NCT04142736

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

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 650 (estimated)
• Sponsor: Corporacion Parc Tauli · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Respiratory Failure With Hypoxia
• Respiratory Failure Without Hypercapnia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-02-07
• Primary completion: 2023-11-01
• Completion: 2023-11-01
• First posted: 2019-10-29
• Last updated: 2022-10-13

Locations

1 site across 1 country: Spain