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Trial record 20 of 199 for:    Recruiting, Not yet recruiting, Available Studies | Neonatal respiratory distress syndrome

Individualized Positive End-expiratory Pressure Guided by End-expiratory Lung Volume in the Acute Respiratory Distress Syndrome (IPERPEEP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04012073
Recruitment Status : Not yet recruiting
First Posted : July 9, 2019
Last Update Posted : July 9, 2019
Sponsor:
Collaborators:
ClinicalTrialCenter
FerrarioDati
General Electric
Information provided by (Responsible Party):
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary:

During the acute respiratory distress syndrome (ARDS), patients' response to positive end-expiratory pressure (PEEP) is variable according to different degrees of lung recruitability. The search for a tool to individualize PEEP on the basis of patients' individual response is warranted.

Measurement of end-expiratory lung volume (EELV) by the nitrogen washin-washout technique, bedside available from recent ICU ventilators, has been shown to reliably estimate PEEP-induced alveolar recruitment and may therefore help titrate PEEP on patient's individual requirements.

The authors designed an open-label, multicenter, randomized trial to test whether an individualized PEEP setting protocol driven by EELV may improve a composite clinical outcome in patients with moderate-to-severe ARDS.


Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome, Adult Device: Invasive Mechanical ventilation Drug: Neuromuscular Blocking Agents Procedure: Prone positioning Procedure: Resume of spontaneous breathing Procedure: Rescue treatments Procedure: Weaning from PEEP Procedure: Weaning from mechanical ventilation Procedure: Extubation Phase 3

Detailed Description:

ARDS patients with a PaO2/FiO2 ratio equal or below 150 mmHg (during mechanical ventilation with PEEP 5 cmH2O) will be enrolled within 24 hours from endo-tracheal intubation.

To standardize lung volumes at study initiation, all patients will undergo mechanical ventilation with tidal volume set at 6 ml/kg of predicted body weight and PEEP set to obtain a plateau pressure within 28 and 30 cmH2O for thirty minutes (Express PEEP).

Afterwards, a 5-step decremental PEEP trial will be conducted (Express PEEP to PEEP 5 cmH2O), and EELV will be measured at each step. PEEP-induced alveolar recruitment will be calculated for each PEEP range as the difference between PEEP-induced change EELV and the predicted increase in lung volume due to PEEP (PEEP-induced overdistension, equal to the product of respiratory system compliance and PEEP change).

Patients will be then randomized to receive mechanical ventilation with PEEP set according to the optimal recruitment observed in the PEEP trial (IPERPEEP arm) trial or according to the Express strategy (Control arm, PEEP set to achieve a plateau pressure of 28-30 cmH2O).

In both groups, tidal volume size, the use of prone positioning and neuromuscular blocking agents will be standardized.

Primary endpoint of the study is a composite clinical outcome incorporating in-ICU mortality, 60-day ventilator free days and the area under the curve of serum Interleukin 6 over the course of the initial 72 hours.

Prespecified subgroup analysis will be conducted according to:

  • [(Express PEEP EELV)-(EELV PEEP 5 cmH2O)]/Functional residual capacity (FRC) ≥ and < 73% during the PEEP trial
  • Rec ≥ 19 ml/cmH2O and Rec < 19 ml/cmH2O across the range between the lowest and highest PEEP tested during the PEEP trial
  • P/F ratio≥ and <100 mmHg at study inclusion
  • IL-6≥ and <400 pg/ml at study inclusion

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomization will be stratified according to Recruitment/cmH2O ≥ or < 19 ml/cmH2O across the range between the lowest and highest PEEP tested during the initial PEEP trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Individualized Positive End-expiRatory Pressure Guided by End-Expiratory Lung Volume in Moderate-to-severe Acute resPiratory Distress Syndrome.The IPERPEEP Study
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : April 30, 2022


Arm Intervention/treatment
Experimental: IPERPEEP

End expiratory lung volume (EELV) will be measured at each step during a 5-step decremental PEEP trial.

Set PEEP will be ≥5 cmH2O and chosen to ensure the maximum recruitment, with a maximum plateau pressure of 30 cmH2O. Recruitment across two adjacent PEEP levels will be normalized to the changes in applied PEEP: Recruitment/cmH2O (Rec) will be computed as the ratio of recruitment and PEEP difference.

  • Rec ≥ 19 ml/cmH2O will lead to the higher PEEP value.
  • Rec< 7 ml/cmH2O will lead to lower PEEP value.
  • 19 ml/cmH2O >Rec≥7ml/cmH2O: the choice among two adjacent PEEP levels will be left to the attending physician.

In patients with airway closure, no PEEP lower than airway opening pressure will be tested or used (due to interferences with EELV measurement) for the whole duration of treatment. A 5-step PEEP trial will re-assess EELV at different PEEP levels every 12-24 hours,after body position or ventilator settings changes.

Device: Invasive Mechanical ventilation

Volume-control ventilation with tidal volume will be set at 6 mL/Kg of predicted body weight, respiratory rate to maintain pH>7.30 and PaCO2<50 mmHg and FiO2 will be set to achieve a SpO2>88-95%.

In case of hypercapnia with Ph<7.30 despite a respiratory rate=30-35, an increase in tidal volume up to 8 ml/kg will be allowed.

In both groups, the assigned ventilation protocol will be followed for a minimum of 72 hours from randomization and any time fully controlled ventilation is deemed necessary by the attending physician up to 14 days from randomization. After 14 days from randomization, PEEP will be set according to the clinical practice of each institution.

After 72 hours from the study protocol, the PEEP setting protocol according to the assigned treatment will be resumed at any time within 14 days from enrolment if fully controlled ventilation is established, according to the decision of the attending physician in charge.


Drug: Neuromuscular Blocking Agents
All patients will receive NMBA for 48 hours after the enrolment. The decision to stop NMBA administration after 48 hours will be left to the attending physician, but muscle paralysis will be strongly encouraged if PaO2/FiO2 ratio remains lower than 80-100 mmHg. NMBA administration will be resumed anytime deemed necessary by the attending physician.

Procedure: Prone positioning
Prone positioning will be used in all enrolled patients as a standard of care: the decision about the timing and the duration of prone position sessions will be left to the attending physician and the time spent by the patient in the prone and in the supine position will be recorded: PEEP will be re-set according to the protocol of the allocated treatment anytime patient's position is changed.

Procedure: Resume of spontaneous breathing

Assist/control and assist ventilation will be allowed after 72 hours from the enrolment if deemed appropriate by the attending physician.

During spontaneous breathing, PEEP will be set according to the decision of the attending physician and the practice of each institution: however, in order to standardize the treatments, moderate PEEP (10-15 cmH2O) will be encouraged in case of moderate hypoxemia (PaO2/FiO2<150 mmHg) in control group, while PEEP close to the value set during controlled ventilation according to the treatment protocol but <15 cmH2O will be suggested in the intervention group.

During assist/control and assisted ventilation, PEEP will never be higher than the last PEEP set according to the assigned protocol during controlled ventilation.

Fully controlled mechanical ventilation will be resumed any time during the study period if the patient meets the criteria described above or any time deemed necessary by the physicians in charge


Procedure: Rescue treatments
Recruitment maneuvers, extracorporeal membrane oxygenation (ECMO), extracorporeal CO2 removal (ECCO2-R) after randomization will be allowed in both groups as rescue therapies and according to the decision of attending physicians: any of these procedures will be accurately recorded on the case report form.

Procedure: Weaning from PEEP

In order not to delay weaning from mechanical ventilation, when a patient is managed with assist/control or assist ventilation with PEEP higher than 8 cmH2O, a daily PEEP weaning trial will be performed whether PaO2/FIO2 ratio>150 mm Hg and FIO2<0.5: PEEP will be decreased to 8-5 cm H2O and arterial blood gas will be sampled after 20 -0 minutes. Previous ventilatory settings will be resumed if during the procedure transcutaneous oxyhemoglobin saturation decreases below 88%, PaO2/FIO2 falls below 150 mm Hg or if the patient experiences abnormal changes in respiratory rate or other clinical signs suggestive of respiratory distress.

When PaO2/FIO2 is no lower than 200 mm Hg at PEEP≤8 cmH2O, the patient will be considered to have acceptable gas exchange on 8-5 cmH2O of PEEP and will be deemed capable to tolerate this setting


Procedure: Weaning from mechanical ventilation

A 30-120-minute spontaneous breathing trial will be initiated as the following criteria are met and whether the patient tolerates fully assist ventilation with PEEP≤8 cmH2O for at least 4 hours without experiencing hypoxemia (SpO2<88% or PaO2/FiO2<150mmHg):

  • improvement or resolution of the underlying cause of acute respiratory failure
  • normal sensorium
  • correction of arterial hypoxemia (PaO2 ≥ 60 mmHg at a FiO2 ≤ 0.4 with PEEP ≤ 8 cmH2O);
  • absence of fever (≥ 38 °C) or sepsis;
  • blood hemoglobin concentration of 7 g/dL or more;
  • hemodynamic stability

For the purpose of the study, success of the spontaneous breathing trial will be defined as presence of the following criteria:

  • respiratory rate < 35/min,
  • arterial oxygen saturation ≥ 90%,
  • heart rate < 120/min,
  • systolic blood pressure > 90 and < 160 mmHg
  • adequate cough. If the spontaneous breathing trial is successful, the patient will be extubated.

Procedure: Extubation

Each extubated patient will undergo oxygen therapy via high flow nasal cannula (maximum flows tolerated and FiO2 titrated to obtain 96%>SpO2>92%). Pre-emptive noninvasive ventilation (NIV) after extubation will be allowed in prolonged to wean patients (i.e. more than 3 SBT failure or more than 7 days from the first spontaneous breathing trial to being extubated) if deemed necessary by the physician in charge.

In case of respiratory failure during oxygen therapy via high flow nasal cannula after extubation and, a rescue NIV trial will be allowed before intubation in both groups at the discretion of the attending physician.


Active Comparator: EXPRESS
PEEP set so that the plateau pressure is within the following limits: 28 cmH2O≤Pplat≤ 30 cmH2O
Device: Invasive Mechanical ventilation

Volume-control ventilation with tidal volume will be set at 6 mL/Kg of predicted body weight, respiratory rate to maintain pH>7.30 and PaCO2<50 mmHg and FiO2 will be set to achieve a SpO2>88-95%.

In case of hypercapnia with Ph<7.30 despite a respiratory rate=30-35, an increase in tidal volume up to 8 ml/kg will be allowed.

In both groups, the assigned ventilation protocol will be followed for a minimum of 72 hours from randomization and any time fully controlled ventilation is deemed necessary by the attending physician up to 14 days from randomization. After 14 days from randomization, PEEP will be set according to the clinical practice of each institution.

After 72 hours from the study protocol, the PEEP setting protocol according to the assigned treatment will be resumed at any time within 14 days from enrolment if fully controlled ventilation is established, according to the decision of the attending physician in charge.


Drug: Neuromuscular Blocking Agents
All patients will receive NMBA for 48 hours after the enrolment. The decision to stop NMBA administration after 48 hours will be left to the attending physician, but muscle paralysis will be strongly encouraged if PaO2/FiO2 ratio remains lower than 80-100 mmHg. NMBA administration will be resumed anytime deemed necessary by the attending physician.

Procedure: Prone positioning
Prone positioning will be used in all enrolled patients as a standard of care: the decision about the timing and the duration of prone position sessions will be left to the attending physician and the time spent by the patient in the prone and in the supine position will be recorded: PEEP will be re-set according to the protocol of the allocated treatment anytime patient's position is changed.

Procedure: Resume of spontaneous breathing

Assist/control and assist ventilation will be allowed after 72 hours from the enrolment if deemed appropriate by the attending physician.

During spontaneous breathing, PEEP will be set according to the decision of the attending physician and the practice of each institution: however, in order to standardize the treatments, moderate PEEP (10-15 cmH2O) will be encouraged in case of moderate hypoxemia (PaO2/FiO2<150 mmHg) in control group, while PEEP close to the value set during controlled ventilation according to the treatment protocol but <15 cmH2O will be suggested in the intervention group.

During assist/control and assisted ventilation, PEEP will never be higher than the last PEEP set according to the assigned protocol during controlled ventilation.

Fully controlled mechanical ventilation will be resumed any time during the study period if the patient meets the criteria described above or any time deemed necessary by the physicians in charge


Procedure: Rescue treatments
Recruitment maneuvers, extracorporeal membrane oxygenation (ECMO), extracorporeal CO2 removal (ECCO2-R) after randomization will be allowed in both groups as rescue therapies and according to the decision of attending physicians: any of these procedures will be accurately recorded on the case report form.

Procedure: Weaning from PEEP

In order not to delay weaning from mechanical ventilation, when a patient is managed with assist/control or assist ventilation with PEEP higher than 8 cmH2O, a daily PEEP weaning trial will be performed whether PaO2/FIO2 ratio>150 mm Hg and FIO2<0.5: PEEP will be decreased to 8-5 cm H2O and arterial blood gas will be sampled after 20 -0 minutes. Previous ventilatory settings will be resumed if during the procedure transcutaneous oxyhemoglobin saturation decreases below 88%, PaO2/FIO2 falls below 150 mm Hg or if the patient experiences abnormal changes in respiratory rate or other clinical signs suggestive of respiratory distress.

When PaO2/FIO2 is no lower than 200 mm Hg at PEEP≤8 cmH2O, the patient will be considered to have acceptable gas exchange on 8-5 cmH2O of PEEP and will be deemed capable to tolerate this setting


Procedure: Weaning from mechanical ventilation

A 30-120-minute spontaneous breathing trial will be initiated as the following criteria are met and whether the patient tolerates fully assist ventilation with PEEP≤8 cmH2O for at least 4 hours without experiencing hypoxemia (SpO2<88% or PaO2/FiO2<150mmHg):

  • improvement or resolution of the underlying cause of acute respiratory failure
  • normal sensorium
  • correction of arterial hypoxemia (PaO2 ≥ 60 mmHg at a FiO2 ≤ 0.4 with PEEP ≤ 8 cmH2O);
  • absence of fever (≥ 38 °C) or sepsis;
  • blood hemoglobin concentration of 7 g/dL or more;
  • hemodynamic stability

For the purpose of the study, success of the spontaneous breathing trial will be defined as presence of the following criteria:

  • respiratory rate < 35/min,
  • arterial oxygen saturation ≥ 90%,
  • heart rate < 120/min,
  • systolic blood pressure > 90 and < 160 mmHg
  • adequate cough. If the spontaneous breathing trial is successful, the patient will be extubated.

Procedure: Extubation

Each extubated patient will undergo oxygen therapy via high flow nasal cannula (maximum flows tolerated and FiO2 titrated to obtain 96%>SpO2>92%). Pre-emptive noninvasive ventilation (NIV) after extubation will be allowed in prolonged to wean patients (i.e. more than 3 SBT failure or more than 7 days from the first spontaneous breathing trial to being extubated) if deemed necessary by the physician in charge.

In case of respiratory failure during oxygen therapy via high flow nasal cannula after extubation and, a rescue NIV trial will be allowed before intubation in both groups at the discretion of the attending physician.





Primary Outcome Measures :
  1. Composite clinical outcome that incorporates ICU mortality, 60-day ventilation-free days (VFD60) and the Area Under the Curve of the InterLeukin-6 serum concentration (IL6AUC) during the first 72 hours of observation [ Time Frame: 60 days ]
    Composite clinical outcome that incorporates ICU mortality, 60-day ventilation-free days (VFD60) and the Area Under the Curve of the InterLeukin-6 serum blood cytokine concentration (IL6AUC) during the first 72 hours of observation. Every participant in the treatment group will be compared with every participant in the control group and assigned a score resulting from each comparison. Mortality takes precedence over VFD60, which takes precedence over IL6AUC. Two VFD60's will be considered different for the purpose of scoring only if their difference is larger than 5 days. Similarly, two IL6AUC's measurements will be considered different only if their difference exceeds 10% of the smaller of the two. These individual-comparison scores are added up to obtain the cumulative score primary endpoint for each participant. The sum of scores for patients in the treatment group is compared to the sum of scores of subjects in the control group and compared according by use of Mann-Whitney test


Secondary Outcome Measures :
  1. In-ICU mortality [ Time Frame: 90 days ]
    Mortality at ICU discharge

  2. In-Hospital mortality [ Time Frame: 90 days ]
    Mortality at hospital discharge

  3. 90-day mortality [ Time Frame: 90 days ]
    Mortality at 90 days from randomization

  4. 28-day Ventilator free days [ Time Frame: 28 days ]
    The days spent without ventilator assistance within 28 days from randomization

  5. 60-day Ventilator free days [ Time Frame: 28 days ]
    The days spent without ventilator assistance within 60 days from randomization

  6. Time to successful weaning [ Time Frame: 90 days ]
    The time from enrolment to successful liberation from mechanical ventilation

  7. Time spent on assisted ventilation after the enrolment [ Time Frame: 28 days ]
    The time spent on assisted ventilation on 28-day basis

  8. AUC IL-6 [ Time Frame: 72 hours ]
    Area under the curve (AUC) of serum interleukin 6 in the initial 72 hours of treatment

  9. AUC IL-8 [ Time Frame: 72 hours ]
    Area under the curve (AUC) of serum interleukin 8 in the initial 72 hours of treatment

  10. AUC TNF [ Time Frame: 72 hours ]
    Area under the curve (AUC) of serum tumor necrosis factor in the initial 72 hours of treatment

  11. Plateau pressure [ Time Frame: 72 hours ]
    Plateau pressure during the assigned treatment

  12. Total Lung stress-End-inspiratory transpulmonary pressure derived from elastance ratio [ Time Frame: 72 hours ]
    Total increase in transpulmonary pressure due to tidal volume and PEEP during the assigned treatment

  13. Static stress [ Time Frame: 72 hours ]
    Total increase in transpulmonary pressure due to PEEP during the assigned treatment

  14. Set PEEP [ Time Frame: 72 hours ]
    Set PEEP during the assigned treatment

  15. Set PEEP variability [ Time Frame: 72 hours ]
    Ratio of standard deviation to mean PEEP during the assigned treatment

  16. End-expiratory transpulmonary pressure [ Time Frame: 72 hours ]
    Directly measured end-expiratory transpulmonary pressure during the assigned treatment

  17. Dynamic stress-Transpulmonary driving pressure [ Time Frame: 72 hours ]
    Total increase in transpulmonary pressure due to tidal volume during the assigned treatment

  18. Respiratory system driving pressure [ Time Frame: 72 hours ]
    The difference between Plateau Pressure and total PEEP during the assigned treatment

  19. Respiratory system compliance [ Time Frame: 72 hours ]
    Ratio of tidal volume to respiratory system driving pressure during the assigned treatment

  20. Respiratory system compliance normalized to predicted body weight [ Time Frame: 72 hours ]
    Ratio of respiratory system compliance and predicted body weight during the assigned treatment

  21. Lung compliance [ Time Frame: 72 hours ]
    Ratio of tidal volume to transpulmonary driving pressure during the assigned treatment

  22. Dynamic strain [ Time Frame: 30 minutes ]
    Ratio of tidal volume to end-expiratory aerated volume (end-expiratory lung volume plus PEEP-induced alveolar recruitment) at study start

  23. Static strain [ Time Frame: 30 minutes ]
    Ratio of PEEP-induced overdistension volume to end-expiratory aerated volume (end-expiratory lung volume plus PEEP-induced alveolar recruitment) at study start

  24. Oxygenation [ Time Frame: 72 hours ]
    Ratio of PaO2 to FiO2 during the assigned treatment

  25. Oxygenation stretch index [ Time Frame: 72 hours ]
    Ratio of PaO2/FiO2 to respiratory system driving pressure during the assigned treatment

  26. Carbon dioxide [ Time Frame: 72 hours ]
    Arterial pressure of CO2 during the assigned treatment

  27. Heart rate [ Time Frame: 72 hours ]
    Heart rate during the assigned treatment

  28. Arterial pressure [ Time Frame: 72 hours ]
    Mean arterial pressure during the assigned treatment

  29. Simplified organ failure assessment [ Time Frame: 28 days ]
    Simplified organ failure assessment (SOFA) after randomization

  30. Catecholamine requirements per day [ Time Frame: 72 hours ]
    Catecholamin administration ad dosage during the assigned treatment

  31. Organ failure [ Time Frame: 28 days ]
    Organ failure free days on a 28-day basis, as defined by the simplified organ failure assessment (SOFA)

  32. Need for rescue recruitment maneuvers [ Time Frame: 72 hours ]
    The proportion of patients needing rescue recruitment maneuvers during the assigned treatment

  33. Nedd for rescue extra-corporeal membrane oxygenation [ Time Frame: 90 days ]
    The proportion of patients needing rescue extra-corporeal membrane oxygenation due to persistent hypoxemia

  34. Nedd for tracheostomy [ Time Frame: 90 days ]
    The proportion of patients needing tracheostomy to enhance the weaning process



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Eligibility inclusion criteria, according to the ARDS Berlin definition, will be assessed within the first 24 hours from the initiation of invasive mechanical ventilation:

  1. Acute respiratory failure within 1 week of a known clinical insult or new or worsening respiratory symptoms;
  2. Bilateral infiltrates at the chest x-ray or CT scan, not fully explained by effusions, lobar/lung collapse, or nodules;
  3. Respiratory failure not fully explained by cardiac failure or fluid overload; objective assessment required to exclude hydrostatic edema if no risk factor present.
  4. PaO2/FiO2 ratio≤150 mmHg after 30 mins - 1 hour of mechanical ventilation with PEEP=5 cmH2O.
  5. Written informed consent.

Exclusion Criteria:

  1. Pregnancy;
  2. Pneumothorax;
  3. Acute brain injury;
  4. Clinical signs of history of decompensated heart failure (New York Heart Association class 3-4 before the acute phase of the disease or documented ejection fraction<35% or pulmonary capillary wedge pressure>18 mmHg) or acute coronary syndrome;
  5. Intubation as a result of an acute exacerbation of chronic pulmonary disease: chronic obstructive pulmonary disease, asthma, cystic fibrosis, etc;
  6. Clinically evident intrinsic PEEP (≥2 cmH2O) during screening visit (End-expiratory pause to achieve Flow=0);
  7. BMI>35;
  8. BMI<15 or body weight<35 Kg;
  9. Any chronic disease requiring long-term oxygen therapy or mechanical ventilation at home;
  10. Neuromuscular disease of any kind;
  11. Severe chronic liver disease (Child-Pugh C or worse);
  12. Bone marrow transplantation or chemotherapy-induced neutropenia;
  13. History of liver or lung transplant;
  14. Decision to withhold life-sustaining treatment;
  15. Need for therapy with inhaled nitric oxide due to documented pulmonary arterial hypertension;
  16. Life-threatening hypoxemia deemed to require extracorporeal membrane oxygenation (ECMO);
  17. Presence of documented barotrauma;
  18. High risk of mortality within 3 months from other than ARDS (severe neurological damage, age >85 years and cancer patients in terminal stages of the disease).
  19. Persistent hemodynamic instability, intractable shock (norepinephrine>1 mcg/kg/h and/or blood lactate>5 mmol/L and/or considered too hemodynamically unstable for enrolment in the study by the patient's managing physician).
  20. More than 24 hours from endotracheal intubation to the time of the screening visit.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04012073


Contacts
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Contact: Margherita Vernau +39 06 3015 ext 7321 margherita.verneau@clinicaltrialcenter.it

Locations
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Italy
Policlinico di Bari Not yet recruiting
Bari, Italy
Contact: Rosa Di Mussi, MD         
Principal Investigator: Salvatore Grasso, MD         
Policlinico Sant'Orsola Not yet recruiting
Bologna, Italy
Contact: Elisabetta Pierucci, MD         
Principal Investigator: Elisabetta Pierucci, MD         
Principal Investigator: Vito Marco Ranieri, MD         
Sub-Investigator: Antonio Siniscalchi, MD         
Azienda ospedaliero-universitaria Mater Domini Not yet recruiting
Catanzaro, Italy
Contact: Paolo Navalesi, MD         
Principal Investigator: Paolo Navalesi, MD         
Sub-Investigator: Federico Longhini, MD         
Sub-Investigator: Andrea Bruni, MD         
Sub-Investigator: Eugenio Garofalo, MD         
SS. Annunziata hospital Not yet recruiting
Chieti, Italy
Contact: Salvatore M Maggiore, MD, PhD         
Principal Investigator: Salvatore M Maggiore, MD, PhD         
Azienda ospedaliera universitaria di Ferrara-arcispedale Sant'Anna Not yet recruiting
Ferrara, Italy
Contact: Savino Spadaro, MD         
Principal Investigator: Carlo Alberto Volta, MD         
Sub-Investigator: Savino Spadaro, MD         
Ospedale San Martino Not yet recruiting
Genova, Italy
Contact: Lorenzo Ball, MD         
Principal Investigator: Paolo Pelosi, MD         
Sub-Investigator: Nicolò Patroniti, MD         
Sub-Investigator: Lorenzo Ball, MD         
Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico Not yet recruiting
Milan, Italy
Contact: Giacomo Grasselli, MD         
Principal Investigator: Giacomo Grasselli, MD         
Sub-Investigator: Tommaso Mauri, MD         
Ospedale San Gerardo Not yet recruiting
Monza, Italy
Contact: Giuseppe Foti, MD         
Principal Investigator: Giuseppe Foti, MD         
Sub-Investigator: Giacomo Bellani, MD         
Sub-Investigator: Vincenzo Russotto, MD         
Fondazione IRCCS Policlinico San Matteo Not yet recruiting
Pavia, Italy
Contact: Francesco Mojoli, MD         
Principal Investigator: Francesco Mojoli, MD         
Sub-Investigator: Giorgio Iotti, MD         
Sub-Investigator: Guido Tavazzi, MD         
Fondazione Policlinico Universitaro A. Gemelli IRCCS Not yet recruiting
Rome, Italy
Contact: Domenico Luca Grieco, MD         
Principal Investigator: Massimo Antonelli, MD         
Sub-Investigator: Antonio M Dell'Anna, MD         
Sub-Investigator: Filippo Bongiovanni, MD         
Sub-Investigator: Giuseppe Bello, MD         
Sub-Investigator: Gian Marco Anzellotti, MD         
Sponsors and Collaborators
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
ClinicalTrialCenter
FerrarioDati
General Electric
Investigators
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Principal Investigator: Massimo Antonelli, MD Fondazione Policlinico Universitario A. Gemelli IRCCS; Università Cattolica del Sacro Cuore
Principal Investigator: Domenico Luca Grieco, MD Fondazione Policlinico Universitario A. Gemelli IRCCS; Università Cattolica del Sacro Cuore

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Responsible Party: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
ClinicalTrials.gov Identifier: NCT04012073     History of Changes
Other Study ID Numbers: ANT-IPE-18-006
First Posted: July 9, 2019    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual patient data will be made available upon a reasonable request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Fondazione Policlinico Universitario Agostino Gemelli IRCCS:
Positive end-expiratory pressure
Ventilator-induced lung injury
Mechanical ventilation
Respiratory mechanics
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Syndrome
Respiratory Tract Diseases
Infant, Newborn, Diseases
Acute Lung Injury
Disease
Pathologic Processes
Lung Diseases
Respiration Disorders
Infant, Premature, Diseases
Lung Injury
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs