Oxygen Therapy During Acute Respiratory Failure in Immuno-compromised Patients

Acute Respiratory Failure Clinical Trial

— RESPIR-OH  

Official title:

Oxygen Therapy During Acute Respiratory Failure in Immuno-compromised Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02424773
• Other study ID #: K101201
• Status: Completed
• Phase: Phase 3
• First received: April 20, 2015
• Last updated: April 15, 2016
• Start date: November 2012
• Est. completion date: April 2015

Study information

• Verified date: April 2015
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Générale de la SantéFrance: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Respiratory Failure
• High Flow Oxygen Cannula
• Immunocompromised Host
• Respiratory Distress Syndrome, Adult
• Respiratory Insufficiency

Intervention

Device:
• High Flow Nasal Canula (HFNC)

• Venturi mask

Drug:
• Oxygen

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygenation failure	Oxygenation failure is defined with the need of invasive Mechanical Ventilation or Non invasive ventilation during the two hours study period	2 hours	No
Secondary	comfort (0-10 Visual analog Scale)	0-10 Visual analog Scale	1 hour	No
Secondary	comfort (0-10 Visual analog Scale)	0-10 Visual analog Scale	2 hours	No
Secondary	dyspnea (0-10 Visual analog Scale)	0-10 Visual analog Scale	1 hour	No
Secondary	dyspnea (0-10 Visual analog Scale)	0-10 Visual analog Scale	2 hour	No
Secondary	thirst (0-10 Visual analog Scale)	0-10 Visual analog Scale	1 hour	No
Secondary	thirst (0-10 Visual analog Scale)	0-10 Visual analog Scale	2 hour	No