Oxygen Therapy During Acute Respiratory Failure in Immuno-compromised Patients

Phase 3

Completed

• Conditions: Acute Respiratory Failure; Immunocompromised Host; High Flow Oxygen Cannula
• Interventions: Device: Venturi mask; Device: High Flow Nasal Canula (HFNC); Drug: Oxygen

• Registration Number: NCT02424773
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Primary Completion: 2014-11
• Status Verified: 2015-04
• Study Completion: 2015-04
• Study First Submitted: 2015-04-20
• Study First Submitted QC: 2015-04-22
• Study First Posted: 2015-04-23
• Last Update Submitted: 2016-04-15
• Last Update Posted: 2016-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Venturi group	Venturi mask	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	High Flow Nasal Canula (HFNC)	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.
Venturi group	Oxygen	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	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.

Primary Outcome Measures

Name	Time	Method
Oxygenation failure	2 hours	Oxygenation failure is defined with the need of invasive Mechanical Ventilation or Non invasive ventilation during the two hours study period

Secondary Outcome Measures

Name	Time	Method
comfort (0-10 Visual analog Scale)	2 hours	0-10 Visual analog Scale
thirst (0-10 Visual analog Scale)	2 hour	0-10 Visual analog Scale
dyspnea (0-10 Visual analog Scale)	2 hour	0-10 Visual analog Scale