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PRone positioN in patiEnts With de Novo Acute hypOxemic Respiratory faiLure Under Nasal hIgh Flow Oxygen theErapy (PRONELIFE)

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ClinicalTrials.gov Identifier: NCT04142736
Recruitment Status : Not yet recruiting
First Posted : October 29, 2019
Last Update Posted : November 30, 2020
Sponsor:
Information provided by (Responsible Party):
Luis Morales, Hospital Quiron Sagrado Corazon

Brief Summary:
This is a trial of a new way of treating patients with respiratory failure. The investigators propose to deliver a multi-centre clinical trial to determine whether prone position in patients with de novo acute hypoxemic respiratory failure under high flow nasal oxygen therapy prevent endotracheal intubation at 28 days after randomisation, in comparison with standard care in patients who are treated with high flow nasal oxygen therapy in the supine position.

Condition or disease Intervention/treatment Phase
Respiratory Failure With Hypoxia Respiratory Failure Without Hypercapnia Other: Prone Position Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 678 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: PRone positioN in patiEnts With de Novo Acute hypOxemic Respiratory faiLure Under Nasal hIgh Flow Oxygen theErapy
Estimated Study Start Date : January 2021
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Prone position
Patients with acute respiratory failure with high flow nasal oxygen therapy and prone position
Other: Prone Position

Patients will undergo HFNC during a 15-minute monitoring window in the supine position. HFNC will be started at 50 l/min and flow set to the patient's tolerance. FiO2 will be titrated to 92% >SpO2 <96 %. If SpO2/FiO2 <123 mmHg or RR>35 bpm, the patient will be excluded for safety reasons. Prone position will last for at least 2 hours. After the PP period, he/she will be turned to supine for 2-4 hours. The total duration of the study will be 48 hours.

Weaning success is considered if the patient remains on standard O2 > 48 hours.


No Intervention: Supine position
Patients with acute respiratory failure with high flow nasal oxygen therapy and supine position



Primary Outcome Measures :
  1. Number of patients who needed endotracheal intubation [ Time Frame: 28 days ]
    Rate of endotracheal intubation in patients under prone position and high flow nasal oxygen therapy


Secondary Outcome Measures :
  1. Number of patients that tolerate the procedure and complete the study according to the protocol without serious adverse events. The following will be considered serious adverse events [ Time Frame: 2 hours ]

    The following will be considered serious adverse events:

    1. Oxygen desaturations (SpO2 <90%)
    2. Episodes of hemodynamic instability (Systolic arterial pressure<80 mmHg or FC>120 bpm)
    3. Displacement of central venous line, if documented
    4. Displacement of arterial line, if documented

  2. Oxygenation [ Time Frame: 2 hours ]
    Effects of prone position on oxygenation, defined by PaO2/FiO2 ratio

  3. Respiratory rate [ Time Frame: 2 hours ]
    Effects of prone position on respiratory rate

  4. Comfort [ Time Frame: 2 hours ]

    Effects of prone position on comfort, defined according a visual analog comfort scale (VAS).

    The VAS is a straight horizontal line of fixed length. The ends are defined as the extreme limits of the parameter to be measured (symptom,pain,health) orientated from the left (worst) to the right (best).


  5. Dyspnea [ Time Frame: 2 hours ]

    Effects of prone position on dyspnea, defined according modified Borg dyspnea scale.

    This is a scale rates the difficulty of breathing. It starts at number 0 where dyspnea is causing no difficulty at all and progresses through to number 10 where dyspnea is maximal.


  6. Nurse workload [ Time Frame: 5 hours ]
    The nurse in charge will be asked to anonymously rate in minutes the additional workload due to the entire procedure (both proning and unproning)

  7. Feasibility scale [ Time Frame: 5 hours ]
    At the end of the study, the nurse in charge will be asked to anonymously judge the feasibility of the procedure using an analog scale ranging from 0 (completely unfeasible) to 10 (totally feasible)

  8. Safety scale [ Time Frame: 5 hours ]
    At the end of the study, the nurse in charge will be asked to anonymously to judge the safety of the procedure using an analog scale ranging from 0 (completely unsafe) to 10 (totally safe)



Information from the National Library of Medicine

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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. > 18 years
  2. Respiratory rate>20 bpm and <35 bpm.
  3. SpO2/FiO2 < 201 in the supine position, measured after 15 minutes of high flow treatment with nasal cannula (50 lt/min, temperature of the humidification chamber set at 37°C, FiO2 more than 0.5 set to achieve a SpO2 >92% and <96%). Given the use of the high flows, nominal FiO2 will be considered a reliable estimate of the actual one.

Exclusion Criteria:

  1. PaO2/FiO2< 100 at inclusion
  2. PaCO2 > 45mmHg
  3. Urgent indication of orotracheal intubation (e.g. cardiac arrest, imminent respiratory arrest, respiratory rate < 12 rpm, respiratory pauses)
  4. More than > 24 hours under HFNC
  5. Anatomical factors precluding the use of HFNC
  6. Contraindication to prone position
  7. Obesity, defined as a body mass index ≥ 30 kg/m2 36
  8. Presence of any contraindication to PP (Appendix 1)
  9. More than 48 hours from the ICU admission
  10. Exacerbation of asthma or chronic obstructive pulmonary disease (COPD) as a cause of acute respiratory failure
  11. Chest trauma
  12. Cardiogenic pulmonary edema as a cause of acute respiratory failure
  13. Severe neutropenia (<500 WBC/mm3)
  14. Shock defined as a Sequential Organ Failure Assessment (SOFA) score of 3 or 4 (on a scale of 0 to 4 for each of six organ systems, with higher scores indicating more severe organ dysfunction) for at least two organs and at least 6 hours, and receipt of vasopressor therapy (norepinephrine, epinephrine, or any other vasopressor at a dose of ≥0.25 μg per kilogram of body weight per minute or ≥1 mg per hour) for at least 6 hours to maintain a systolic blood pressure of at least 90 mm Hg or a mean blood pressure of at least 65 mm Hg
  15. Metabolic Acidosis (pH <7.35 HCO3- < 24 mEq/l)
  16. Chronic kidney failure requiring dialysis before ICU admission
  17. Glasgow coma scale <13
  18. Vomiting and/or upper gastrointestinal bleeding
  19. Pregnancy or breastfeeding
  20. Participation in other interventional studies
  21. Patients not expected to survive 6 months on the basis of premorbid health status
  22. History of uncontrolled, major psychiatric disorder
  23. Therapeutic restriction (DNR), moribund patient or not expected to survive current hospitalization
  24. Consent declined

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): NCT04142736


Contacts
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Contact: Luis Morales-Quinteros, MD + 34 648493973 luchomq2077@gmail.com
Contact: Diego de Mendoza, MD +34 647613915 diego.mendoza@quironsalud.es

Locations
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Spain
Hospital Universitari Sagrat Cor, Grupo Quironsalud
Barcelona, Spain, 08029
Contact: Luis Morales, MD    +34 648493973    luchomq2077@gmail.com   
Contact: Diego de Mendoza, MD    +34 647613915    diego.mendoza@quironsalud.es   
Sponsors and Collaborators
Hospital Quiron Sagrado Corazon
Investigators
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Principal Investigator: Antonio Artigas, MD Hospital Universitari Sagrat Cor, Grupo Quironsalud
Publications:

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Responsible Party: Luis Morales, Study Coordinator, Hospital Quiron Sagrado Corazon
ClinicalTrials.gov Identifier: NCT04142736    
Other Study ID Numbers: 2019/68-UCI-HUSC
First Posted: October 29, 2019    Key Record Dates
Last Update Posted: November 30, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Data will be available within 6 months of study completion
Access Criteria: Data access request will be reviewed by an External Independent Review Panel. Requestors will be required to signed a Data Access Agreement

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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 Luis Morales, Hospital Quiron Sagrado Corazon:
Prone position
High flow oxygen therapy
Additional relevant MeSH terms:
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Respiratory Insufficiency
Hypoxia
Hypercapnia
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory