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Respiratory Failure With HypoxiaPRONELIFENCT04142736

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

A study testing Prone Position in people with Respiratory Failure With Hypoxia and Respiratory Failure Without Hypercapnia, run by Corporacion Parc Tauli at 1 site in Spain.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Prone Position
Could I receive a placebo?
No, everyone receives an active treatment
How many people
650 participants
Where
1 siteSpain
Study dates
7 Feb 2022to Nov 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Spain1 site

  • I3PT Institut d'Investigació i Innovació Parc Taulí

    Sabadell, Barcelona, 08208

Other trials in Spain

About this study

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.

Read the 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.

Being tested
Prone Position
Keywords
Prone position, Acute Respiratory Failure
Medical subject headings
Respiratory Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT04142736
Study groupRoleWhat they receive
Prone positionExperimentalPatients with acute hypoxemic respiratory failure from any cause
Receives: Other: Prone Position
Supine positionNo interventionPatients with acute hypoxemic respiratory failure from any cause

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 14 days

Secondary outcomes (12)

  1. Mortality at day 14

    Effect of prone position on mortality

    Measured: 14 days

  2. Intubation among survivors at day 24

    Effect of prone position on the rate of intubation

    Measured: 24 days

  3. Effects on oxygenation defined by the SpO2

    Effects of prone position on oxygenation

    Measured: 4 hours

  4. Days under the oxygen support device

    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).

    Measured: 28 days

  5. Dyspnea

    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.

    Measured: 4 hours

  6. Time to tracheal intubation

    Effects of prone position on timing for tracheal intubation

    Measured: 14 days

  7. Rate of complications related to prone position

    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

    Measured: 4 hours

  8. Respiratory rate

    Effects of prone position of respiratory rate

    Measured: 4 hours

  9. Duration of invasive mechanical ventilation

    Duration of invasive mechanical ventilation in those patients who required intubation

    Measured: 90 days

  10. Ventilation-free days (VFD) at 28 days from ICU admission,

    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

    Measured: 28 days

  11. ICU-free days and hospital-free days

    ICU-free days and hospital-free days at day 90

    Measured: 90 days

  12. Mortality

    Mortality at day 28 and day 90

    Measured: 28 and 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2019
  2. Study start7 Feb 2022
  3. Primary completionNov 2023 (estimated)
  4. Study completionNov 2023 (estimated)

Why it stopped: low recruitment rate

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
650 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04142736
Sponsor's protocol ID
2019/68-UCI-HUSC
Acronym
PRONELIFE
Status last verified
Oct 2022
First submitted
25 Oct 2019
Last updated
13 Oct 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available

Publications

  • 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.

    PubMed 25981908

  • 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.

    PubMed 23688302

  • 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.

    PubMed 26271685

  • 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.

    PubMed 23050520

  • 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.

    PubMed 35012606

Questions about this trial

What is this clinical trial studying?

A study testing Prone Position in people with Respiratory Failure With Hypoxia and Respiratory Failure Without Hypercapnia, run by Corporacion Parc Tauli at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite endpoint comprising the rate of tracheal intubation or all-cause of mortality during the first fourteen days of enrolment. (time frame: 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04142736, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022.

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