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

Respiratory Failure With Hypoxia Clinical Trial

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

Status Suspended

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT04142736
• Study type: Interventional
• Source: Corporacion Parc Tauli
• Status: Suspended
• Phase: N/A
• Start date: February 7, 2022
• Completion date: November 2023