NCT01320384

Brief Summary

The aim of the study is to compare, in patients with acute respiratory failure/acute lung injury the efficacy of three different methods of oxygenation to prevent endotracheal intubation :

  1. 1.conventional oxygen therapy (O2 conventional)
  2. 2.high flow nasal oxygen therapy (O2-HFN)
  3. 3.association of high flow nasal oxygen therapy with non invasive positive pressure ventilation (O2-HFN/NPPV).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
313

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

Status
completed

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 7, 2010

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 22, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

October 11, 2016

Status Verified

October 1, 2016

Enrollment Period

2.3 years

First QC Date

October 7, 2010

Last Update Submit

October 10, 2016

Conditions

Acute Lung InjuryAcute Respiratory Failure

Keywords

ALI

Outcome Measures

Primary Outcomes (1)

  • To compare the number of patients in each group who require endotracheal intubation with mechanical ventilation

    at day 28

Secondary Outcomes (2)

  • mechanical ventilation-free to day 28

    28 days

  • ICU morbidity

    at day 28

Study Arms (3)

O2 conventional : standard low flow therapy

ACTIVE COMPARATOR

in order to obtain a SpO2\>92%

Other: O2 conventional

O2-HNF : high flow nasal oxygen therapy

EXPERIMENTAL

set between 30 to 50 l/min,adjusted in order to obtain a SpO2 \>92%.

Device: O2-HFN : high flow nasal oxygen therapy

O2-HFN/NPPV

EXPERIMENTAL

cycling of NIV and O2-HDN

Device: O2-HFN/NPPV : association of high flow nasal oxygen therapy and non invasive positive pressure ventilation

Interventions

O2 conventionalOTHER

standard low flow therapy

O2 conventional : standard low flow therapy
O2-HFN : high flow nasal oxygen therapyDEVICE

The patient will receive high flow nasal of humidified oxygen, set between 30 to 50 l/min. The inspired fraction of oxygen (FiO2) will be adjusted in order to obtain a SpO2 \>92%.

O2-HNF : high flow nasal oxygen therapy
O2-HFN/NPPV : association of high flow nasal oxygen therapy and non invasive positive pressure ventilationDEVICE

The patient will receive successively in a day NPPV and O2-HFN. The NPPV will be applied with an airway humidification achieved by using a heated humidifier and a facial mask adapted to the morphology of the patient. The settings will be adjusted as follow : an inspiratory pressure between 6 to 14 cmH2O, in order to obtain a tidal volume between 7 to 10 ml/kg of predicted weight, a positive expiratory pressure between 0 to 10 cmH2O in order to obtain a SpO2 \>92% with the minimal FiO2.

O2-HFN/NPPV

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Hypoxemic and no hypercapnic acute respiratory failure :
  • severe dyspnea at rest with a respiratory rate \>25 breaths/min
  • PaO2/FiO2 \<300
  • PaCO2 \<45 mmHg,

You may not qualify if:

  • age \<18 years
  • NPPV contraindications
  • past history of respiratory chronic disease (COPD, cystic fibrosis…)
  • cardiac pulmonary edema
  • Pre-defined intubation
  • other than respiratory organ failure : systolic pressure \<90 mmHg,current treatment with epinephrine or norepinephrine, decreased level of consciousness ( Glasgow score ≤ 12)
  • profound aplasia (white cells count \<1000/mm 3)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Poitiers University Hospital

Poitiers, 86021, France

Location

Related Publications (2)

  • Demoule A, Baptiste A, Thille AW, Similowski T, Ragot S, Prat G, Mercat A, Girault C, Carteaux G, Boulain T, Perbet S, Decavele M, Belin L, Frat JP; from the REVA Network (Research Network in Mechanical Ventilation). Dyspnea is severe and associated with a higher intubation rate in de novo acute hypoxemic respiratory failure. Crit Care. 2024 May 23;28(1):174. doi: 10.1186/s13054-024-04903-5.

    PMID: 38783367DERIVED

  • 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: 25981908DERIVED

MeSH Terms

Conditions

Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 7, 2010

First Posted

March 22, 2011

Study Start

March 1, 2011

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

October 11, 2016

Record last verified: 2016-10

Locations

FR(1)