Oxygen Therapy During Acute Respiratory Failure in Immuno-compromised Patients (RESPIR-OH)
Primary Purpose
Acute Respiratory Failure, Immunocompromised Host, High Flow Oxygen Cannula
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
High Flow Nasal Canula (HFNC)
Venturi mask
Oxygen
Sponsored by
About this trial
This is an interventional treatment trial for Acute Respiratory Failure
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Venturi group
HFNC group
Arm Description
Venturi group : Oxygen is delivered using oxygen Venturi mask FiO2 is started at 60% (15l/min) and modified to maintain SpO2 over 94%.
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.
Outcomes
Primary Outcome Measures
Oxygenation failure
Oxygenation failure is defined with the need of invasive Mechanical Ventilation or Non invasive ventilation during the two hours study period
Secondary Outcome Measures
comfort (0-10 Visual analog Scale)
0-10 Visual analog Scale
comfort (0-10 Visual analog Scale)
0-10 Visual analog Scale
dyspnea (0-10 Visual analog Scale)
0-10 Visual analog Scale
dyspnea (0-10 Visual analog Scale)
0-10 Visual analog Scale
thirst (0-10 Visual analog Scale)
0-10 Visual analog Scale
thirst (0-10 Visual analog Scale)
0-10 Visual analog Scale
Full Information
NCT ID
NCT02424773
First Posted
April 20, 2015
Last Updated
April 15, 2016
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT02424773
Brief Title
Oxygen Therapy During Acute Respiratory Failure in Immuno-compromised Patients
Acronym
RESPIR-OH
Official Title
Oxygen Therapy During Acute Respiratory Failure in Immuno-compromised Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Failure, Immunocompromised Host, High Flow Oxygen Cannula
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Venturi group
Arm Type
Active Comparator
Arm Description
Venturi group : Oxygen is delivered using oxygen Venturi mask FiO2 is started at 60% (15l/min) and modified to maintain SpO2 over 94%.
Arm Title
HFNC group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
High Flow Nasal Canula (HFNC)
Intervention Type
Device
Intervention Name(s)
Venturi mask
Intervention Type
Drug
Intervention Name(s)
Oxygen
Primary Outcome Measure Information:
Title
Oxygenation failure
Description
Oxygenation failure is defined with the need of invasive Mechanical Ventilation or Non invasive ventilation during the two hours study period
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
comfort (0-10 Visual analog Scale)
Description
0-10 Visual analog Scale
Time Frame
1 hour
Title
comfort (0-10 Visual analog Scale)
Description
0-10 Visual analog Scale
Time Frame
2 hours
Title
dyspnea (0-10 Visual analog Scale)
Description
0-10 Visual analog Scale
Time Frame
1 hour
Title
dyspnea (0-10 Visual analog Scale)
Description
0-10 Visual analog Scale
Time Frame
2 hour
Title
thirst (0-10 Visual analog Scale)
Description
0-10 Visual analog Scale
Time Frame
1 hour
Title
thirst (0-10 Visual analog Scale)
Description
0-10 Visual analog Scale
Time Frame
2 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophie COURTIAL DESTEMBERT
Organizational Affiliation
DRCD APHP Paris
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
26521922
Citation
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.
Results Reference
result
Learn more about this trial
Oxygen Therapy During Acute Respiratory Failure in Immuno-compromised Patients
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