SuspendedNot Applicable

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

Stopped: low recruitment rate

Spain650 participantsStarted 2022-02-07

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Composite endpoint comprising the rate of tracheal intubation or all-cause of mortality during the first fourteen days of enrolment.

Timeframe: 14 days

Trial details

NCT IDNCT04142736

SponsorCorporacion Parc Tauli

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-11

View on ClinicalTrials.gov More Respiratory Failure With Hypoxia trials