A new way to treat patients with respiratory failure: lying on the front while awake

ISRCTN	ISRCTN11536318
DOI	https://doi.org/10.1186/ISRCTN11536318
ClinicalTrials.gov (NCT)	NCT04142736
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	Nil known
Sponsor	Institute of Research and Innovation Parc Tauli
Funder	Institut d'Investigació i Innovació Parc Taulí (I3PT)

Submission date: 15/09/2021
Registration date: 17/09/2021
Last edited: 28/02/2025

Recruitment status: Suspended
Overall study status: Suspended
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Intubation is when doctor puts a tube down your throat and into your windpipe to make it easier to get air into and out of your lungs. A machine called a ventilator pumps in air with extra oxygen. Hypoxemic respiratory failure means that you don't have enough oxygen in your blood.
It is uncertain whether awake prone positioning (lying on the front) can prevent the need for intubation for invasive ventilation in critically ill patients with acute hypoxemic respiratory failure. Awake prone positioning could benefit these patients for various reasons, including a reduction in direct harm to lung tissue, and prevention of tracheal intubation-related complications.
The aim is to compare standard care with awake prone positioning versus standard care without awake prone positioning in patients with acute hypoxemic respiratory failure.

Who can participate?
Adult patients with acute hypoxemic respiratory failure.

What does the study involve?
Participants will be randomly allocated to be placed into the prone position or to receive treatment as usual. Patients will be followed up for 90 days.

What are the possible benefits and risks of participating?
Expected benefits are patient's symptomatology improvement which can hasten recovery, improve long and short term outcomes, reduce ICU and hospital length of stay.
Possible risk are those associated to the procedure, such as removal of catheter or devices already been in placed, worsening hypoxemia resulting in emergent orotracheal intubation.

Where is the study run from?
Institut d'Investigació i Innovació Parc Taulí (I3PT) (Spain)

When is the study starting and how long is it expected to run for?
September 2019 to January 2025

Who is funding the study?
Institut d'Investigació i Innovació Parc Taulí (I3PT) (Spain)

Who is the main contact?
Dr Luis Morales-Quinteros, luchomq2077@gmail.com

Contact information

Dr Luis Morales-Quinteros
Scientific

Carrer de Sant Quintí, 89
Barcelona
08041
Spain

ORCID ID	0000-0002-8937-9824
Phone	+34 648493973
Email	luisfernando.morales@vallhebron.cat

Study information

Primary study design	Interventional
Study design	International multicenter randomized controlled clinical trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	PRone positioN in patients with spontanEous ventiLation and acute hypoxemic respIratory FailurE- The PRONELIFE Randomized Controlled Trial
Study acronym	PRONELIFE
Study objectives	Awake prone position in patients with acute hypoxemic respiratory failure is associated with a decreased need for intubation
Ethics approval(s)	Approved 08/09/2021, Quiron Salud IRB (CEIm Grupo Hospitalario Quirónsalud-Catalunya. Pedro i Pons, 1 08195 Sant Cugat del Vallès, Barcelona, Spain; +34 93 565 60 00 Ext 5935; ceic.idcsa.cat@idcsalud.es), ref: 2019/68-UCI-HUSC
Health condition(s) or problem(s) studied	Body position during acute hypoxemic respiratory failure
Intervention	PRONE POSITIONING The study intervention will last for at least 48 hours and is divided into 4 blocks of 6 hours each: patients will be placed in the prone position for up to 2 hours, which can be prolonged if the patient feels comfortable, but could also be interrupted if a patient meets any of the discontinuation criteria which are any of the following:  developing a contraindication;  worsening of dyspnea (at any time, according to predefined criteria);  a further and sustained drop in SpO2 refractory to an increase in FiO2;  nausea or vomiting; and  increasing hemodynamic instability that is unrelated to sedatives (if given) and cannot be corrected by vasopressor or inotrope infusion During the change in position, from supine to prone or from prone to supine, FiO2 will be increased by 25% above baseline. Each change in position is guided by two healthcare workers and an attending physician, but more healthcare workers could be needed. While the patient remains in a prone position, skin protection will be used to avoid pressure sores. Also, the application of cushions will enhance patient tolerance. Arms can be at the side, in a swimmer's position, and can be moved to increase comfort. Food and comfort breaks are planned while patients are in supine. If the patient is receiving enteral or oral feeding, this is interrupted from 1 hour before prone until a patient is in a supine 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). STANDARD OF CARE In all patients, whether receiving prone positioning or not, the best standard of care is provided, according to the standard care by the local teams. RANDOMIZATION AND BLINDING Randomization will be performed using a dedicated password–protected website and will be balanced per center. Central randomization with the use of a permutated–block randomization list (with block sizes of 4 to 8) will be used. Participants will be allocated to the prone positioning or standard care on a 1:1 ratio. By the nature of the intervention it will not be possible to blind clinicians to whether a participant has been randomized to awake prone position or standard care.
Intervention type	Other
Primary outcome measure(s)	Composite of tracheal intubation and all–cause mortality in the first 14 days after enrolment measured using patient records
Key secondary outcome measure(s)	Measured using patient records unless otherwise noted: 1. Mortality at day 14 2. Intubation among survivors at day 24 3. Effects on oxygenation defined by the SpO2 at 4 hours 4. Days under the oxygen support device in 28 days 5. Dyspnea defined according modified Borg dyspnea scale at 4 hours 6. Time to tracheal intubation within 14 days 7. Rate of complications related to prone position at 4 hours: 7.1. Oxygen desaturations (SpO2 <90%) 7.2. Episodes of hemodynamic instability (BPsys < 90mmHg or BPsys drop > 10mmHg if BPsys < 90 before the maneuver) 7.3. Need of orotracheal intubation 7.4. Cardiac arrest 7.5. Displacement of the non-invasive respiratory support device 7.6. Removal of central venous line, if documented 7.7. Displacement of an arterial line, if documented 7.8. Displacement of a urinary catheter, if documented 8. Respiratory rate at 4 hours 9. Duration of invasive mechanical ventilation over 90 days 10. 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 11. ICU-free days and hospital-free days at day 90 12. Mortality at day 28 and day 90
Completion date	01/01/2025
Reason abandoned (if study stopped)	Participant recruitment issue

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	650
Key inclusion criteria	1. >18 years 2. Acute respiratory failure from any cause 3. Admitted to a participating ICU 4. Written informed consent
Key exclusion criteria	1. Presence of any contraindication to prone position 2. The patient meets the criteria for intubation 3. Participating in other interventional studies with the same primary outcome 4. Receiving comfort care only 5. Pregnancy
Date of first enrolment	07/02/2022
Date of final enrolment	01/01/2024

Locations

Countries of recruitment

Ecuador
France
Spain

Study participating centres

Hospital de la Santa Creu i Sant Pau.

Carrer de Sant Quintí, 89
Barcelona
08041
Spain

Hospital Universitari Sagrat Cor.

Carrer de Viladomat, 288
Barcelona
08029
Spain

Hospital Universitari General de Catalunya.

Carrer Pedro i Pons, 1
Sant Cugat del Vallès
Barcelona
08195
Spain

Fundació Althaia.

C/ Dr. Joan Soler, 1-3
Manresa
Barcelona
08243
Spain

Hospital Vicente Corral Moscoso.

Av. Los Arupos y Av. 12 de Abril
Cuenca
010107
Ecuador

Centre Hospitalier Universitaire de Lille.

2 Avenue Oscar Lambret
Lille
59000
France

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Other
IPD sharing plan	All data generated or analysed during this study will be included in the subsequent results publication

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

28/02/2025: The study has been placed on hold due to low patient recruitment. Contact details updated.
15/02/2022: The recruitment start date has been changed from 01/02/2022 to 07/02/2022.
24/01/2022: The recruitment start date has been changed from 01/01/2022 to 01/02/2022.
17/09/2021: Trial's existence confirmed by Quiron Salud.