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Clinical Trials/NCT02424773
NCT02424773
Completed
Phase 3

Oxygen Therapy During Acute Respiratory Failure in Immuno-compromised Patients

Assistance Publique - Hôpitaux de Paris0 sites100 target enrollmentNovember 2012

Overview

Phase
Phase 3
Intervention
Venturi mask
Conditions
Acute Respiratory Failure
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
100
Primary Endpoint
Oxygenation failure
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2012
End Date
April 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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
  • Pregnancy

Arms & Interventions

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%.

Intervention: Venturi mask

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%.

Intervention: Oxygen

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.

Intervention: High Flow Nasal Canula (HFNC)

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.

Intervention: Oxygen

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • comfort (0-10 Visual analog Scale)(2 hours)
  • thirst (0-10 Visual analog Scale)(2 hour)
  • dyspnea (0-10 Visual analog Scale)(2 hour)

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