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

Corporacion Parc Tauli

Status: Suspended

Conditions: Respiratory Failure With Hypoxia; Respiratory Failure Without Hypercapnia

Treatments: Other: Prone Position

Study type: Interventional

Funder types: Other

Identifiers

NCT04142736

2019/68-UCI-HUSC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 650 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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650 participants in 2 patient groups

Prone position

Experimental group

Description:

Patients with acute hypoxemic respiratory failure from any cause

Treatment:

Other: Prone Position

Supine position

No Intervention group

Description:

Patients with acute hypoxemic respiratory failure from any cause