Oxygen Therapy During Acute Respiratory Failure in Immuno-compromised Patients (RESPIR-OH)

April 15, 2016 updated by: Assistance Publique - Hôpitaux de Paris
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Venturi group
Venturi group : Oxygen is delivered using oxygen Venturi mask FiO2 is started at 60% (15l/min) and modified to maintain SpO2 over 94%.
Drug: Oxygen
Device: Venturi mask
Experimental: HFNC group
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.
Drug: Oxygen
Device: High Flow Nasal Canula (HFNC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygenation failure
Time Frame: 2 hours
Oxygenation failure is defined with the need of invasive Mechanical Ventilation or Non invasive ventilation during the two hours study period
2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
comfort (0-10 Visual analog Scale)
Time Frame: 1 hour
0-10 Visual analog Scale
1 hour
comfort (0-10 Visual analog Scale)
Time Frame: 2 hours
0-10 Visual analog Scale
2 hours
dyspnea (0-10 Visual analog Scale)
Time Frame: 1 hour
0-10 Visual analog Scale
1 hour
dyspnea (0-10 Visual analog Scale)
Time Frame: 2 hour
0-10 Visual analog Scale
2 hour
thirst (0-10 Visual analog Scale)
Time Frame: 1 hour
0-10 Visual analog Scale
1 hour
thirst (0-10 Visual analog Scale)
Time Frame: 2 hour
0-10 Visual analog Scale
2 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Study Director: Sophie COURTIAL DESTEMBERT, DRCD APHP Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

April 20, 2015

First Submitted That Met QC Criteria

April 22, 2015

First Posted (Estimate)

April 23, 2015

Study Record Updates

Last Update Posted (Estimate)

April 18, 2016

Last Update Submitted That Met QC Criteria

April 15, 2016

Last Verified

April 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K101201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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