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

  • STATUS
    Recruiting
  • End date
    Nov 13, 2023
  • participants needed
    650
  • sponsor
    Corporacion Parc Tauli
Updated on 13 April 2022

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.

Details
Condition Respiratory Failure With Hypoxia, Respiratory Failure Without Hypercapnia
Treatment Prone position
Clinical Study IdentifierNCT04142736
SponsorCorporacion Parc Tauli
Last Modified on13 April 2022

Eligibility

Yes No Not Sure

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
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