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Completed

NCT Number: NCT02424773

Oxygen Therapy During Acute Respiratory Failure in Immuno-compromised Patients

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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Key information

Conditions

Acute Respiratory Failure High Flow Oxygen Cannula Immunocompromised Host

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Flow Nasal Canula (HFNC)

Device

Venturi mask

Device

Oxygen

Drug

Primary outcomes

  1. 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

  1. comfort (0-10 Visual analog Scale)

    Time frame: 1 hour

    0-10 Visual analog Scale

  2. comfort (0-10 Visual analog Scale)

    Time frame: 2 hours

    0-10 Visual analog Scale

  3. dyspnea (0-10 Visual analog Scale)

    Time frame: 1 hour

    0-10 Visual analog Scale

  4. dyspnea (0-10 Visual analog Scale)

    Time frame: 2 hour

    0-10 Visual analog Scale

  5. thirst (0-10 Visual analog Scale)

    Time frame: 1 hour

    0-10 Visual analog Scale

  6. thirst (0-10 Visual analog Scale)

    Time frame: 2 hour

    0-10 Visual analog Scale

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: RESPIR-OH

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Apr 23, 2015
Registry last updated
Apr 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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