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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
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    April 20, 2015
    Last Updated
    April 15, 2016
    Sponsor
    Assistance Publique - Hôpitaux de Paris
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    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

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    Oxygen Therapy During Acute Respiratory Failure in Immuno-compromised Patients

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