PRone positioN in Patients With spontanEous ventiLation and Acute Hypoxemic respIratory FailurE

Respiratory Failure With Hypoxia Clinical Trial

— PRONELIFE  

Official title:

PRone positioN in Patients With spontanEous ventiLation and Acute Hypoxemic respIratory FailurE

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04142736
• Other study ID #: 2019/68-UCI-HUSC
• Status: Suspended
• Phase: N/A
• Start date: February 7, 2022
• Est. completion date: November 2023

Study information

• Verified date: October 2022
• Source: Corporacion Parc Tauli
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The proposed randomized controlled trial aims at comparing the application of the prone position in spontaneously breathing patients with acute hypoxemic respiratory failure from any cause versus standard treatment on the rate of invasive mechanical ventilation or all-cause of mortality. The secondary endpoints will include time to tracheal intubation and effects of awake proning on the oxygenation parameters, dyspnea sensation, complications, and tolerance. Other endpoints are ventilation free-days at 28 days, duration of invasive ventilation, length of ICU and hospital stay, ICU and hospital mortality, and 28, 60, and 90-day mortality.

Description:

The investigators intend to recruit acute hypoxemic respiratory failure patients with a respiratory rate of more than 25 breaths per minute, SpO2 < 94% and FiO2 of at least 40% or more by either Venturi facemask, HFNC, or NIV/CPAP and, absence of decompensated respiratory acidosis during two years. Currently, the investigators expect about 35 centers to participate in the trial.

Demographic data and clinical characteristics on screened patients, regardless of enrolment criteria match, will be recorded (registry). The investigators will randomize 650 patients admitted to the participating centers' intensive care units and expect each participating center to randomize at least 25 patients who meet all inclusion criteria.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 650
• Est. completion date: November 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria

• >18 years

• Acute respiratory failure from any cause

• Admitted to a participating ICU

• Written informed consent

Exclusion criteria

• Presence of any contraindication to prone position (APPENDIX i)

• The patient meets the criteria for intubation (see item 7.2.3)

• Participating in other interventional studies with the same primary outcome

• Receiving comfort care only

• Pregnancy

Related Conditions & MeSH terms

• Hypercapnia
• Hypoxia
• Respiratory Failure With Hypoxia
• Respiratory Failure Without Hypercapnia
• Respiratory Insufficiency

Intervention

Other:
• Prone Position
The best-fitting and most-tolerated oxygen interface will be used in the prone position--this could be different from patient to patient, and different from what is used in the supine position, and could differ between patients but also institutions (i.e., depending on the availability of masks with or without a reservoir bag and with or without the Venturi system, HFNO, CPAP or NIV). The patient will be placed in the prone position for at least 2 hours, which may be prolonged if the patient is comfortable or interrupted if the patient presents any criteria for prone position discontinuation. After the prone position period, the patient will be rotated to the semi-recumbent supine position for at least 2 hours and a maximum of 4 hours. This 2-hour time frame will depend on nursing availability, need for hygiene, complementary explorations, or diet.

Locations

Country	Name	City	State
Spain	I3PT Institut d'Investigació i Innovació Parc Taulí	Sabadell	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

References & Publications (4)

Frat JP, Thille AW, Mercat A, Girault C, Ragot S, Perbet S, Prat G, Boulain T, Morawiec E, Cottereau A, Devaquet J, Nseir S, Razazi K, Mira JP, Argaud L, Chakarian JC, Ricard JD, Wittebole X, Chevalier S, Herbland A, Fartoukh M, Constantin JM, Tonnelier JM, Pierrot M, Mathonnet A, Béduneau G, Delétage-Métreau C, Richard JC, Brochard L, Robert R; FLORALI Study Group; REVA Network. High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. N Engl J Med. 2015 Jun 4;372(23):2185-96. doi: 10.1056/NEJMoa1503326. Epub 2015 May 17. — View Citation

Guérin C, Reignier J, Richard JC, Beuret P, Gacouin A, Boulain T, Mercier E, Badet M, Mercat A, Baudin O, Clavel M, Chatellier D, Jaber S, Rosselli S, Mancebo J, Sirodot M, Hilbert G, Bengler C, Richecoeur J, Gainnier M, Bayle F, Bourdin G, Leray V, Girard R, Baboi L, Ayzac L; PROSEVA Study Group. Prone positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013 Jun 6;368(23):2159-68. doi: 10.1056/NEJMoa1214103. Epub 2013 May 20. — View Citation

Riera J, Pérez P, Cortés J, Roca O, Masclans JR, Rello J. Effect of high-flow nasal cannula and body position on end-expiratory lung volume: a cohort study using electrical impedance tomography. Respir Care. 2013 Apr;58(4):589-96. doi: 10.4187/respcare.02086. — View Citation

Scaravilli V, Grasselli G, Castagna L, Zanella A, Isgrò S, Lucchini A, Patroniti N, Bellani G, Pesenti A. Prone positioning improves oxygenation in spontaneously breathing nonintubated patients with hypoxemic acute respiratory failure: A retrospective study. J Crit Care. 2015 Dec;30(6):1390-4. doi: 10.1016/j.jcrc.2015.07.008. Epub 2015 Jul 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite endpoint comprising the rate of tracheal intubation or all-cause of mortality during the first fourteen days of enrolment.		14 days
Secondary	Mortality at day 14	Effect of prone position on mortality	14 days
Secondary	Intubation among survivors at day 24	Effect of prone position on the rate of intubation	24 days
Secondary	Effects on oxygenation defined by the SpO2	Effects of prone position on oxygenation	4 hours
Secondary	Days under the oxygen support device	Days under the oxygen support device (HFNC, NIV, non-rebreather mask, Venturi mask) 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).	28 days
Secondary	Dyspnea	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.	4 hours
Secondary	Time to tracheal intubation	Effects of prone position on timing for tracheal intubation	14 days
Secondary	Rate of complications related to prone position	Effects of prone position on adverse effects such Oxygen desaturations (SpO2 <90%); Episodes of hemodynamic instability (BPsys < 90mmHg or BPsys drop > 10mmHg if BPsys < 90 before the maneuver); Need of orotracheal intubation; Cardiac arrest; Displacement of the non-invasive respiratory support device; Removal of central venous line, if documented; Displacement of an arterial line, if documented; Displacement of a urinary catheter, if documented	4 hours
Secondary	Respiratory rate	Effects of prone position of respiratory rate	4 hours
Secondary	Duration of invasive mechanical ventilation	Duration of invasive mechanical ventilation in those patients who required intubation	90 days
Secondary	Ventilation-free days (VFD) at 28 days from ICU admission,	Ventilation-free days (VFD) at 28 days from ICU admission, defined as the number of days alive and free from IMV during the first 28 days from start of IMV	28 days
Secondary	ICU-free days and hospital-free days	ICU-free days and hospital-free days at day 90	90 days
Secondary	Mortality	Mortality at day 28 and day 90	28 and 90 days