NCT04142736

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
650

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 29, 2019

Completed
2.3 years until next milestone

Study Start

First participant enrolled

February 7, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

October 13, 2022

Status Verified

October 1, 2022

Enrollment Period

1.7 years

First QC Date

October 25, 2019

Last Update Submit

October 11, 2022

Conditions

Respiratory Failure With HypoxiaRespiratory Failure Without Hypercapnia

Keywords

Prone positionAcute Respiratory Failure

Outcome Measures

Primary Outcomes (1)

  • Composite endpoint comprising the rate of tracheal intubation or all-cause of mortality during the first fourteen days of enrolment.

    14 days

Secondary Outcomes (12)

  • Mortality at day 14

    14 days

  • Intubation among survivors at day 24

    24 days

  • Effects on oxygenation defined by the SpO2

    4 hours

  • Days under the oxygen support device

    28 days

  • Dyspnea

    4 hours

  • +7 more secondary outcomes

Study Arms (2)

Prone position

EXPERIMENTAL

Patients with acute hypoxemic respiratory failure from any cause

Other: Prone Position

Supine position

NO INTERVENTION

Patients with acute hypoxemic respiratory failure from any cause

Interventions

Prone PositionOTHER

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.

Prone position

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>18 years
  • Acute respiratory failure from any cause
  • Admitted to a participating ICU
  • Written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

I3PT Institut d'Investigació i Innovació Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

Related Publications (5)

  • Frat JP, Thille AW, Mercat A, Girault C, Ragot S, Perbet S, Prat G, Boulain T, Morawiec E, Cottereau A, Devaquet J, Nseir S, Razazi K, Mira JP, Argaud L, Chakarian JC, Ricard JD, Wittebole X, Chevalier S, Herbland A, Fartoukh M, Constantin JM, Tonnelier JM, Pierrot M, Mathonnet A, Beduneau G, Deletage-Metreau C, Richard JC, Brochard L, Robert R; FLORALI Study Group; REVA Network. High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. N Engl J Med. 2015 Jun 4;372(23):2185-96. doi: 10.1056/NEJMoa1503326. Epub 2015 May 17.

    PMID: 25981908BACKGROUND

  • Guerin C, Reignier J, Richard JC, Beuret P, Gacouin A, Boulain T, Mercier E, Badet M, Mercat A, Baudin O, Clavel M, Chatellier D, Jaber S, Rosselli S, Mancebo J, Sirodot M, Hilbert G, Bengler C, Richecoeur J, Gainnier M, Bayle F, Bourdin G, Leray V, Girard R, Baboi L, Ayzac L; PROSEVA Study Group. Prone positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013 Jun 6;368(23):2159-68. doi: 10.1056/NEJMoa1214103. Epub 2013 May 20.

    PMID: 23688302BACKGROUND

  • Scaravilli V, Grasselli G, Castagna L, Zanella A, Isgro S, Lucchini A, Patroniti N, Bellani G, Pesenti A. Prone positioning improves oxygenation in spontaneously breathing nonintubated patients with hypoxemic acute respiratory failure: A retrospective study. J Crit Care. 2015 Dec;30(6):1390-4. doi: 10.1016/j.jcrc.2015.07.008. Epub 2015 Jul 16.

    PMID: 26271685BACKGROUND

  • Riera J, Perez P, Cortes J, Roca O, Masclans JR, Rello J. Effect of high-flow nasal cannula and body position on end-expiratory lung volume: a cohort study using electrical impedance tomography. Respir Care. 2013 Apr;58(4):589-96. doi: 10.4187/respcare.02086.

    PMID: 23050520BACKGROUND

  • Morales-Quinteros L, Schultz MJ, Serpa-Neto A, Antonelli M, Grieco DL, Roca O, Juffermans NP, de Haro C, de Mendoza D, Blanch L, Camprubi-Rimblas M, Goma G, Artigas-Raventos A; PRONELIFE collaborative group. Awake prone positioning in nonintubated spontaneous breathing ICU patients with acute hypoxemic respiratory failure (PRONELIFE)-protocol for a randomized clinical trial. Trials. 2022 Jan 10;23(1):30. doi: 10.1186/s13063-021-05991-2.

    PMID: 35012606DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Interventions

Prone Position

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Antonio Artigas, MD, PhD

    I3PT Institut d'Investigació i Innovació Parc Taulí

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Coordinator

Study Record Dates

First Submitted

October 25, 2019

First Posted

October 29, 2019

Study Start

February 7, 2022

Primary Completion

November 1, 2023

Study Completion

November 1, 2023

Last Updated

October 13, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will share

De-identified individual participant data for all primary and secondary outcome measures will be made available

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Data will be available within 6 months of study completion
Access Criteria
Data access request will be reviewed by an External Independent Review Panel. Requestors will be required to signed a Data Access Agreement

Locations

ES(1)