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NCT Number: NCT06213168

Impact on Mortality of a Strategy Including Continuous Positive Airway Pressure Plus High Flow Nasal Cannula Oxygen Therapy Versus High Flow Nasal Cannula Oxygen Therapy Alone in Patients With de Novo Acute Hypoxemic Respiratory Failure: a Prospective, Randomized Controlled Trial.

De novo hypoxemic acute respiratory failure (hARF) is one of the main causes of intensive care unit (ICU) admission. In de novo hARF, intubation is associated with a dramatic increase in mortality rate. Compared to standard oxygen, the use of high-flow oxygen nasal cannula (HFNC) might be beneficial to prevent intubation and mortality, although the results of trials and meta-analyses are conflicting. Even with HFNC, the intubation rate remains high. This is the reason why adjunctive therapies, administered in addition to HFNC are needed.

Continuous positive airway pressure (CPAP) is one of these adjunctive therapies. CPAP provides high level of positive end-expiratory pressure that ensures lung recruitment, but without adding inspiratory pressure support, which prevents ventilator induced lung injury. In addition, as opposed to pressure support, CPAP is well tolerated during long periods of time. Therefore, applying CPAP in addition to HFNC may reduce intubation rate and in turn mortality rate.

The present trial will evaluate the impact on mortality of a strategy including continuous positive airway pressure plus high flow nasal cannula oxygen therapy versus high flow nasal cannula oxygen therapy alone in patients with de novo acute hypoxemic respiratory failure: a Prospective, Randomized Controlled Trial

Recruiting

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Key information

Conditions

De Novo Hypoxemic Acute Respiratory Failure (hARF)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens-Picardie, Amiens, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults (≥ 18 years old)
  • Admitted in the ICU for ≤ 24 hours
  • De novo hARF defined by the three following criteria:
  • Respiratory rate > 25 breaths/min or signs of respiratory distress such as labored breathing or paradoxical inspiration
  • PaO2/FiO2 ≤ 200 mmHg under HFNC with flow ≥ 45 L/min, actual FiO2 being considered.
  • Uni or bilateral pulmonary infiltrate on chest X-ray or CT scan
  • Informed consent from the patient or her/his next of kin or another substitute decision maker, or inclusion procedure in emergency if the patient is unable to consent

Exclusion criteria

  • Refusal of study participation by the patient or the proxy
  • Anatomical factors precluding the use of a nasal cannula or CPAP
  • Long term oxygen
  • Home CPAP or NIV or CPAP or NIV initiated prior to ICU admission
  • Hypercapnia indicating NIV (PaCO2 > 45 mmHg)
  • Isolated cardiogenic pulmonary oedema indicating NIV
  • Known pregnancy or breastfeeding
  • Absence of coverage by the French statutory health care insurance system (including AME)
  • Abdominal, thoracic or cardiac surgery within the last 6 days
  • Use of vasopressors (norepinephrine>0.3 mcg/kg/min)
  • Glasgow coma scale < 13
  • Urgent need for endotracheal intubation
  • Patients at an end-of-life stage receiving compational oxygenation
  • Exacerbation of a chronic respiratory disease
  • Legal protection (curatorship or tutorship)
  • Undrained pneumothorax

Treatment and study plan

HFNC

Other

Patients assigned to the control group will be continuously treated by HFNC. HFNC will be initiated within one hour following randomization

Other names: High flow nasal cannula oxygen therapy

CPAP and HFNC

Other

Patients assigned to the intervention group will receive high flow nasal oxygen plus CPAP sessions

Other names: Continuous positive airway pressure and High flow nasal canulae

Primary outcomes

  1. Mortality

    Time frame: 90 days

    Time to death within the 90 days after randomization

Secondary outcomes

  1. Time from randomization to intubation.

    Time frame: 28 days

  2. Intensity of dyspnea until intubation as assessed by a visual analogic scale from zero (no dyspnea) to 100 (maximum possible dyspnea).

    Time frame: 2, 6, 12 and 24 hours

  3. Respiratory rate

    Time frame: 6, 12 and 24 hours

  4. ROX index

    Time frame: 6, 12 and 24 hours

  5. Evaluation of intolerance to oxygenation technique until intubation

    Time frame: 12 and 24 hours

    evaluation based on the following physical criteria: eyes dryness, nose dryness and/or feeling of gastric distention

  6. Discomfort associated with the interface as assessed by a visual analogic scale from zero (no discomfort) to 100 (maximum possible discomfort).

    Time frame: 12 and 24 hours

  7. Level of oxygenation assessed by blood gas that will be sampled on the request of the physician in charge (clinical purpose only).

    Time frame: First 24 hours or until intubation

  8. Use of NIV for one of the following predefined indication criteria.

    Time frame: through study completion

    • the constitution of a clear indication such as acute-on-chronic respiratory failure with respiratory acidosis (pH < 7.35) or acute cardiogenic pulmonary edema,
    • pre oxygenation before intubation,
    • fiberoptic bronchoscopy.

  9. Death within the ICU

    Time frame: through patient participation period,180 days maximum

  10. Time to death

    Time frame: through patient participation period, an average of 180 days maximum

  11. Death within the hospital and time to death.

    Time frame: through patient participation period,180 days maximum

  12. Number of invasive ventilation-free days at 28 days defined as days alive and without intubation.

    Time frame: Between day 1 and day 28

    One point will be given for each day during the measurement period, i.e. from the first day of randomization to day 28 that patients will be both alive and free of invasive mechanical ventilation. Zero value will be given for patients who die before day 28.

  13. Number of HFNC-free days at 28 days defined as days non-intubated, alive and without HFNC.

    Time frame: Between day 1 and day 28.

    One point will be given for each day during the measurement period, i.e. from the first day of randomization to day 28 that patients will be both alive and free of HFNO and invasive mechanical ventilation. Zero value will be given for patients who die or are intubated before day 28.

  14. ICU length of stay.

    Time frame: through patient participation period,180 days maximum

  15. Hospital length of stay.

    Time frame: through patient participation period,180 days maximum

  16. Occurrence of any adverse event during the ICU stay, with a particular focus on hospital or ventilator associated pneumonia, non-respiratory infections, cardiac arrhythmia, and cardiac arrest.

    Time frame: through patient participation period,180 days maximum

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandre DEMOULE

CONTACT

[email protected]

+33 (0)1 42 16 77 61

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Impact on Mortality of a Strategy Including Continuous Positive Airway Pressure Plus High Flow Nasal Cannula Oxygen Therapy Versus High Flow Nasal Cannula Oxygen Therapy Alone in Patients With de Novo Acute Hypoxemic Respiratory Failure: a Prospective, Randomized Controlled Trial

Acronym: HighCPAP

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 19, 2024
Registry last updated
Apr 13, 2026

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.