NCT02424773

Brief Summary

In immunocompromised patients, Acute Respiratory Failure (ARF) is associated with a high case-fatality, particularly when invasive Mechanical Ventilation (MV) is required. In the most hypoxemic patients, oxygen administration through High Flow Nasal Cannula (HFNC) has been reported as an alternative to the venturi mask. The aim of this study is to compare HFNC and venturi mask on early respiratory deterioration and patient's comfort in that setting. The investigators planned a prospective randomized study in 4 Intensive Care Units (ICUs). As respiratory deterioration occurs early after ICU admission, patients are randomized to receive two hours of oxygen therapy either through HFNC or venturi mask. The primary endpoint is defined as the need for invasive or noninvasive MV in the 2-hour period. Secondary endpoints include comfort, dyspnea and thirst.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2012

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

Study Start

First participant enrolled

November 1, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 23, 2015

Completed
Last Updated

April 18, 2016

Status Verified

April 1, 2015

Enrollment Period

2 years

First QC Date

April 20, 2015

Last Update Submit

April 15, 2016

Conditions

Acute Respiratory FailureImmunocompromised HostHigh Flow Oxygen Cannula

Outcome Measures

Primary Outcomes (1)

  • Oxygenation failure

    Oxygenation failure is defined with the need of invasive Mechanical Ventilation or Non invasive ventilation during the two hours study period

    2 hours

Secondary Outcomes (6)

  • comfort (0-10 Visual analog Scale)

    1 hour

  • comfort (0-10 Visual analog Scale)

    2 hours

  • dyspnea (0-10 Visual analog Scale)

    1 hour

  • dyspnea (0-10 Visual analog Scale)

    2 hour

  • thirst (0-10 Visual analog Scale)

    1 hour

  • +1 more secondary outcomes

Study Arms (2)

Venturi group

ACTIVE COMPARATOR

Venturi group : Oxygen is delivered using oxygen Venturi mask FiO2 is started at 60% (15l/min) and modified to maintain SpO2 over 94%.

Device: Venturi maskDrug: Oxygen

HFNC group

EXPERIMENTAL

HFNC group : Oxygen is delivered using HFNC. HFNC is started with FIO2 =1 and modified to maintain SpO2 over 94%, flow is settled at 40-50l/min.

Device: High Flow Nasal Canula (HFNC)Drug: Oxygen

Interventions

High Flow Nasal Canula (HFNC)DEVICE
HFNC group
Venturi maskDEVICE
Venturi group
OxygenDRUG
HFNC groupVenturi group

Eligibility Criteria

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

You may qualify if:

  • Age over 18 years.
  • Admission to ICU for ARF. ARF was defined with the need of oxygen over 6l/min to maintain SpO2 over 95% or symptom of respiratory distress (intercostal recession or tachypnea \>30/min or dyspnea at rest).
  • Immunosuppression. Immunosuppressed conditions were solid tumor, hematological malignancy, steroid treatment or other immunosuppressive treatment, or HIV infection.

You may not qualify if:

  • Hypercapnia (above 47 mmHg)
  • Chronic respiratory failure
  • Previous mechanical ventilation in the days before admission
  • Need of immediate NIV or intubation
  • Refusal
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Lemiale V, Mokart D, Mayaux J, Lambert J, Rabbat A, Demoule A, Azoulay E. The effects of a 2-h trial of high-flow oxygen by nasal cannula versus Venturi mask in immunocompromised patients with hypoxemic acute respiratory failure: a multicenter randomized trial. Crit Care. 2015 Nov 2;19:380. doi: 10.1186/s13054-015-1097-0.

    PMID: 26521922RESULT

MeSH Terms

Interventions

Oxygen

Intervention Hierarchy (Ancestors)

ChalcogensElementsInorganic ChemicalsGases

Study Officials

  • Sophie COURTIAL DESTEMBERT

    DRCD APHP Paris

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2015

First Posted

April 23, 2015

Study Start

November 1, 2012

Primary Completion

November 1, 2014

Study Completion

April 1, 2015

Last Updated

April 18, 2016

Record last verified: 2015-04