PRone positioN in Patients With spontanEous ventiLation and Acute Hypoxemic respIratory FailurE
- Conditions
- Respiratory Failure Without HypercapniaRespiratory Failure With Hypoxia
- Interventions
- Other: Prone Position
- Registration Number
- NCT04142736
- Lead Sponsor
- Corporacion Parc Tauli
- Brief 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.
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 650
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Prone position Prone Position Patients with acute hypoxemic respiratory failure from any cause
- Primary Outcome Measures
Name Time Method Composite endpoint comprising the rate of tracheal intubation or all-cause of mortality during the first fourteen days of enrolment. 14 days
- Secondary Outcome Measures
Name Time Method Intubation among survivors at day 24 24 days Effect of prone position on the rate of intubation
Respiratory rate 4 hours Effects of prone position of respiratory rate
Duration of invasive mechanical ventilation 90 days Duration of invasive mechanical ventilation in those patients who required intubation
Effects on oxygenation defined by the SpO2 4 hours Effects of prone position on oxygenation
Ventilation-free days (VFD) at 28 days from ICU admission, 28 days Ventilation-free days (VFD) at 28 days from ICU admission, defined as the number of days alive and free from IMV during the first 28 days from start of IMV
ICU-free days and hospital-free days 90 days ICU-free days and hospital-free days at day 90
Days under the oxygen support device 28 days Days under the oxygen support device (HFNC, NIV, non-rebreather mask, Venturi mask) The VAS is a straight horizontal line of fixed length. The ends are defined as the extreme limits of the parameter to be measured (symptom,pain,health) orientated from the left (worst) to the right (best).
Dyspnea 4 hours Effects of prone position on dyspnea, defined according modified Borg dyspnea scale.
This is a scale rates the difficulty of breathing. It starts at number 0 where dyspnea is causing no difficulty at all and progresses through to number 10 where dyspnea is maximal.Time to tracheal intubation 14 days Effects of prone position on timing for tracheal intubation
Mortality 28 and 90 days Mortality at day 28 and day 90
Mortality at day 14 14 days Effect of prone position on mortality
Rate of complications related to prone position 4 hours Effects of prone position on adverse effects such Oxygen desaturations (SpO2 \<90%)
* Episodes of hemodynamic instability (BPsys \< 90mmHg or BPsys drop \> 10mmHg if BPsys \< 90 before the maneuver)
* Need of orotracheal intubation
* Cardiac arrest
* Displacement of the non-invasive respiratory support device
* Removal of central venous line, if documented
* Displacement of an arterial line, if documented
* Displacement of a urinary catheter, if documented
Trial Locations
- Locations (1)
I3PT Institut d'Investigació i Innovació Parc Taulí
🇪🇸Sabadell, Barcelona, Spain