PRone positioN in patiEnts With de Novo Acute hypOxemic Respiratory faiLure Under Nasal hIgh Flow Oxygen theErapy (PRONELIFE)
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|ClinicalTrials.gov Identifier: NCT04142736|
Recruitment Status : Not yet recruiting
First Posted : October 29, 2019
Last Update Posted : November 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Failure With Hypoxia Respiratory Failure Without Hypercapnia||Other: Prone Position||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||678 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||PRone positioN in patiEnts With de Novo Acute hypOxemic Respiratory faiLure Under Nasal hIgh Flow Oxygen theErapy|
|Estimated Study Start Date :||January 2021|
|Estimated Primary Completion Date :||January 2023|
|Estimated Study Completion Date :||January 2023|
Experimental: Prone position
Patients with acute respiratory failure with high flow nasal oxygen therapy and prone position
Other: Prone Position
Patients will undergo HFNC during a 15-minute monitoring window in the supine position. HFNC will be started at 50 l/min and flow set to the patient's tolerance. FiO2 will be titrated to 92% >SpO2 <96 %. If SpO2/FiO2 <123 mmHg or RR>35 bpm, the patient will be excluded for safety reasons. Prone position will last for at least 2 hours. After the PP period, he/she will be turned to supine for 2-4 hours. The total duration of the study will be 48 hours.
Weaning success is considered if the patient remains on standard O2 > 48 hours.
No Intervention: Supine position
Patients with acute respiratory failure with high flow nasal oxygen therapy and supine position
- Number of patients who needed endotracheal intubation [ Time Frame: 28 days ]Rate of endotracheal intubation in patients under prone position and high flow nasal oxygen therapy
- Number of patients that tolerate the procedure and complete the study according to the protocol without serious adverse events. The following will be considered serious adverse events [ Time Frame: 2 hours ]
The following will be considered serious adverse events:
- Oxygen desaturations (SpO2 <90%)
- Episodes of hemodynamic instability (Systolic arterial pressure<80 mmHg or FC>120 bpm)
- Displacement of central venous line, if documented
- Displacement of arterial line, if documented
- Oxygenation [ Time Frame: 2 hours ]Effects of prone position on oxygenation, defined by PaO2/FiO2 ratio
- Respiratory rate [ Time Frame: 2 hours ]Effects of prone position on respiratory rate
- Comfort [ Time Frame: 2 hours ]
Effects of prone position on comfort, defined according a visual analog comfort scale (VAS).
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 [ Time Frame: 2 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.
- Nurse workload [ Time Frame: 5 hours ]The nurse in charge will be asked to anonymously rate in minutes the additional workload due to the entire procedure (both proning and unproning)
- Feasibility scale [ Time Frame: 5 hours ]At the end of the study, the nurse in charge will be asked to anonymously judge the feasibility of the procedure using an analog scale ranging from 0 (completely unfeasible) to 10 (totally feasible)
- Safety scale [ Time Frame: 5 hours ]At the end of the study, the nurse in charge will be asked to anonymously to judge the safety of the procedure using an analog scale ranging from 0 (completely unsafe) to 10 (totally safe)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04142736
|Contact: Luis Morales-Quinteros, MD||+ 34 email@example.com|
|Contact: Diego de Mendoza, MD||+34 firstname.lastname@example.org|
|Principal Investigator:||Antonio Artigas, MD||Hospital Universitari Sagrat Cor, Grupo Quironsalud|