Clinical trial NCT04142736: PRone positioN in Patients With spontanEous ventiLation and Acute Hypoxemic respIratory FailurE
Official title: PRone positioN in Patients With spontanEous ventiLation and Acute Hypoxemic respIratory FailurE
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Respiratory Failure With Hypoxia
Respiratory Failure Without Hypercapnia
Keywords: Prone position
Acute Respiratory Failure
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2019-10-29
Enrollment: 650
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite endpoint comprising the rate of tracheal intubation or all-cause of mortality during the first fourteen days of enrolment.
timeFrame: 14 days
Secondary outcomes:
measure: Mortality at day 14
timeFrame: 14 days
measure: Intubation among survivors at day 24
timeFrame: 24 days
measure: Effects on oxygenation defined by the SpO2
timeFrame: 4 hours
measure: Days under the oxygen support device
timeFrame: 28 days
measure: Dyspnea
timeFrame: 4 hours
measure: Time to tracheal intubation
timeFrame: 14 days
measure: Rate of complications related to prone position
timeFrame: 4 hours
measure: Respiratory rate
timeFrame: 4 hours
measure: Duration of invasive mechanical ventilation
timeFrame: 90 days
measure: Ventilation-free days (VFD) at 28 days from ICU admission,
timeFrame: 28 days
measure: ICU-free days and hospital-free days
timeFrame: 90 days
measure: Mortality
timeFrame: 28 and 90 days
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: I3PT Institut d'Investigació i Innovació Parc Taulí
state: Barcelona
Study officials:
affiliation: I3PT Institut d'Investigació i Innovació Parc Taulí
name: Antonio Artigas, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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, Beduneau G, Deletage-Metreau 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.
citation: Guerin 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.
citation: Scaravilli V, Grasselli G, Castagna L, Zanella A, Isgro 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.
citation: Riera J, Perez P, Cortes 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.
citation: Morales-Quinteros L, Schultz MJ, Serpa-Neto A, Antonelli M, Grieco DL, Roca O, Juffermans NP, de Haro C, de Mendoza D, Blanch L, Camprubi-Rimblas M, Goma G, Artigas-Raventos A; PRONELIFE collaborative group. Awake prone positioning in nonintubated spontaneous breathing ICU patients with acute hypoxemic respiratory failure (PRONELIFE)-protocol for a randomized clinical trial. Trials. 2022 Jan 10;23(1):30. doi: 10.1186/s13063-021-05991-2.