Oxygen Therapy During Acute Respiratory Failure in Immuno-compromised Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2015-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Acute Respiratory Failure Immunocompromised Host High Flow Oxygen Cannula

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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%.

Group Type ACTIVE_COMPARATOR

Venturi mask

Intervention Type DEVICE

Oxygen

Intervention Type DRUG

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.

Group Type EXPERIMENTAL

High Flow Nasal Canula (HFNC)

Intervention Type DEVICE

Oxygen

Intervention Type DRUG

Interventions

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High Flow Nasal Canula (HFNC)

Intervention Type DEVICE

Venturi mask

Intervention Type DEVICE

Oxygen

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No