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Artificial Increase in Chest Wall Elastance as an Alternative to Prone Positioning in Moderate-to-severe ARDS. (ALTERPRONE)

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ClinicalTrials.gov Identifier: NCT03719937
Recruitment Status : Recruiting
First Posted : October 25, 2018
Last Update Posted : October 25, 2018
Sponsor:
Information provided by (Responsible Party):
Massimo Antonelli, Catholic University of the Sacred Heart

Brief Summary:

During moderate to severe ARDS, sessions of prone positioning lead to lung and chest wall mechanics changes that modify regional ventilation, with a final redistribution of tidal volume and PEEP towards dependent lung regions: this limits ventilator-induced lung injury, increases oxygenation and convincingly improves clinical outcome.

Physiological data indicate that the increase in chest wall elastance is crucial in determining the benefit by prone positioning on oxygenation. In some patients, however, prone positioning may not be feasible or safe due to particular comorbidities and/or technical issues.

In the present pilot-feasibility study enrolling 15 subjects with moderate to severe ARDS in whom prone positioning is contraindicated or unfeasible, we aim at assessing whether and to what extent an artificial increase in chest wall elastance while the patient is in the supine position may yield a significant benefit to oxygenation. The increase in chest wall elastance will be achieved placing 100g/kg weight on the anterior chest wall of the patient while he/she is in the supine position: this approach previoulsy appeared safe and effective in case reports and small case series. Patient's position will be standardized (30 degrees head-up, semi seated position).

This one-arm sequential study will evaluate the effects of the procedure on gas exchange, haemodynamics, lung and chest wall mechanics, alveolar recruitment (measured with the nitrogen washout-technique and multiple PV curves) and tidal volume and PEEP distribution (assessed with electrical impedance tomography).


Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome Device: weight on the anterior chest of the patient Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Sequential Assignment
Intervention Model Description: pilot-feasibility study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ArtificiaL Increase in chesT Wall Elastance as an alteRnative to PRONE Positioning in Moderate-to-severe ARDS: a Physiological Study The ALTERPRONE Study
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : April 1, 2020
Estimated Study Completion Date : April 2020


Arm Intervention/treatment
Experimental: anterior chest wall weight
moderate to severe ARDS patients in whom prone positioning is contraindicated. Patients will have a 100 g/kg weight placed on the anterior chest wall, while in the supine/semirecumbant position. The weights will be placed on the patients' chest for 120 minutes, and then removed. A number of measurements will be recorded before and after the procedure.
Device: weight on the anterior chest of the patient
The investigators aim at assessing whether and to what extent an artificial increase in chest wall elastance, while the patient is in the supine position, may yield a significant benefit to oxygenation. The increase in chest wall elastance will be will be achieved placing a 100 g/kg weight on the anterior chest wall of the patient while he/she is in the supine/semirecumbant position. The weights will be placed on the patients' chest for 120 minutes, and then removed. A number of measurements will be recorded before and after the procedure.




Primary Outcome Measures :
  1. oxygenation [ Time Frame: 120 minutes after the intervention ]
    PaO2/FiO2 ratio


Secondary Outcome Measures :
  1. Alveolar recruitment [ Time Frame: 1 and 2 hours after the intervention ]

    Changes in End expiratory lung impedance (EELI), measured with electrical impedance tomography

    A ten-minute period EIT signals will be recorded and offline reviewed using a dedicated software. Image acquisition rate will be 30 Hz. Lungs will be divided into four regions (ventral, mid-ventral, mid-dorsal and dorsal): the % of impedance variation related to tidal volume and the % EELI in the four regions as compared to the absolute values will be calculated


  2. tidal volume dsitribution [ Time Frame: 1 and 2 hours after the intervention ]

    Changes in Tidal volume distribution in 4 area of the lungs (Ventral, mid ventral, mid-dorsal, dorsal)

    A ten-minute period EIT signals will be recorded and offline reviewed using a dedicated software. Image acquisition rate will be 30 Hz. Lungs will be divided into four regions (ventral, mid-ventral, mid-dorsal and dorsal): the % of impedance variation related to tidal volume and the % EELI in the four regions as compared to the absolute values will be calculated


  3. Lung stress [ Time Frame: 1 and 2 hours after the intervention ]

    Measured at the end of an end-inspiratory occlusion, as: airway pressure - esophageal pressure + esophageal pressure at atmospheric pressure

    Static and dynamic strain will be calculated according to the following formulas:

    Lung Stress= PplatAW-PplatESO-PEEPES,ZEEP Dynamic strain = VT/FRCPEEPset Static strain= Strain due to peep ([PEEPvolume-RecZEEP at PEEP/FRCPEEPset) Pressure-volume curves at PEEP0 AND set PEEP will be conducted to confirm the reliability of the previous calculations at the end of each of the study steps


  4. Dynamic strain [ Time Frame: 1 and 2 hours after the intervention ]

    Computed as the ratio of tidal volume to functional residual capacit, with the latter measured with the nitrogen washin-washout technique

    Static and dynamic strain will be calculated according to the following formulas:

    Lung Stress= PplatAW-PplatESO-PEEPES,ZEEP Dynamic strain = VT/FRCPEEPset Static strain= Strain due to peep ([PEEPvolume-RecZEEP at PEEP/FRCPEEPset) Pressure-volume curves at PEEP0 AND set PEEP will be conducted to confirm the reliability of the previous calculations at the end of each of the study steps


  5. Driving pressure [ Time Frame: 1 and 2 hours after the intervention ]
    Respiratory system elastic pressure, measured as plateau pressure-PEEP

  6. Transpulmonary Driving pressure [ Time Frame: 1 and 2 hours after the intervention ]
    Lung elastic pressure, measured as transpulmonary plateau pressure- transpulmonary PEEP

  7. Chest wall elastance [ Time Frame: 1 and 2 hours after the intervention ]
    Elastance of abdomen/chest wall, measured as tidal change in Pes/tidal volume



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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

Inclusion Criteria:

  1. Patients with ARDS and moderate to severe oxygenation impairment (PaO2/FiO2≤150 mmHg while receiving controlled mechanical ventilation with PEEP=5 cmH2O) will be the studied population.

    Acute respiratory failure within 1 week of a known clinical insult or new or worsening respiratory symptoms;

    • Bilateral infiltrates at the chest x-ray or CT scan, not fully explained by effusions, lobar/lung collapse, or nodules;
    • Respiratory failure not fully explained by cardiac failure or fluid overload; objective assessment required to exclude hydrostatic edema if no risk factor present.
    • PaO2/FiO2 ratio<150 mmHg after 30 mins - 1 hour of mechanical ventilation with PEEP=5 cmH2O(14).
    • Written informed consent.
  2. Prone positioning deemed non-feasible by the attending clinician, or presence of at least one of the following absolute contraindications for prone positioning(5)

    • Serious facial trauma or facial surgery during the previous 15 days
    • Deep venous thrombosis treated for less than 2 days
    • Unstable spine, femur, or pelvic fractures
    • Pregnant women
    • Intracranial pressure >30 mm Hg or cerebral perfusion pressure <60 mm

Exclusion Criteria:

  • Chest trauma
  • Cardiothoracic surgery in the last 4/6 weeks
  • Cardiac PM inserted the last 2 days
  • Haemodynamic instability (MAP < 65 mmHg despite vasoactive/inotrope support)
  • Chest tube with air leaks
  • Presence of intrinsic PEEP > 1 cmH2O
  • BMI < 18
  • Height < 150 cm
  • More than 48 hours from endotracheal intubation to the time of randomization

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): NCT03719937


Contacts
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Contact: Roberta Barelli, MD +39 32860011430 robertabarelli@me.com
Contact: Domenico L Grieco, MD +39 3397681623 dlgrieco@outlook.it

Locations
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Italy
General ICU, A. Gemelli hospital Recruiting
Rome, Italy, 00100
Contact: Domenico Luca Grieco, MD    +393397681623    dlgrieco@ymail.com   
Sub-Investigator: Antonio Maria Dell'Anna, MD         
Sub-Investigator: Davide Eleuteri, MD         
Sub-Investigator: Gian Marco Anzellotti, MD         
Sub-Investigator: Sonia D'Arrigo, MD, PhD         
Sub-Investigator: Giovanna Mercurio, MD         
Sub-Investigator: Eloisa Sofia Tanzarella, MD         
Sub-Investigator: Maria Teresa Santantonio, MD         
Sub-Investigator: Giorgia Spinazzola, MD         
Sub-Investigator: Giuliano Ferrone, MD         
Sub-Investigator: Anselmo Caricato, MD         
Sub-Investigator: Giorgio Conti, MD         
Principal Investigator: Roberta Barelli, MD         
Sub-Investigator: Domenico Luca Grieco, MD         
Sponsors and Collaborators
Catholic University of the Sacred Heart
Investigators
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Study Chair: Massimo Antonelli, MD Catholic University of the Sacred Heart

Publications of Results:

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Responsible Party: Massimo Antonelli, Head of the department of Anesthesia and Intensive care medicine, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT03719937     History of Changes
Other Study ID Numbers: 1505
First Posted: October 25, 2018    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Massimo Antonelli, Catholic University of the Sacred Heart:
prone positioning
chest wall mechanics
alveolar recruitment
acute respiratory distress syndrome
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury