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Oxygen Therapy During Acute Respiratory Failure in Immuno-compromised Patients

Oxygen Therapy During Acute Respiratory Failure in Immuno-compromised Patients

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02424773
Acronym
RESPIR-OH
Enrollment
100
Registered
2015-04-23
Start date
2012-11-30
Completion date
2015-04-30
Last updated
2016-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Failure, Immunocompromised Host, High Flow Oxygen Cannula

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.

Interventions

DEVICEHigh Flow Nasal Canula (HFNC)
DRUGOxygen

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Oxygenation failure2 hoursOxygenation failure is defined with the need of invasive Mechanical Ventilation or Non invasive ventilation during the two hours study period

Secondary

MeasureTime frameDescription
comfort (0-10 Visual analog Scale)1 hour0-10 Visual analog Scale
dyspnea (0-10 Visual analog Scale)1 hour0-10 Visual analog Scale
thirst (0-10 Visual analog Scale)1 hour0-10 Visual analog Scale

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026