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.

N/ANot Yet RecruitingNCT06213168

Assistance Publique - Hôpitaux de Paris1,084 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

1,084

Conditions

De Novo Hypoxemic Acute Respiratory Failure (hARF)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Adults (≥ 18 years old) 2. Admitted in the ICU for ≤ 24 hours 3. De novo hARF defined by the three following criteria: 1. Respiratory rate \> 25 breaths/min or signs of respiratory distress such as labored breathing or paradoxical inspiration 2. PaO2/FiO2 ≤ 200 mmHg under HFNC with flow ≥ 45 L/min, actual FiO2 being considered. 3. Uni or bilateral pulmonary infiltrate on chest X-ray or CT scan 4. 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: 1. Refusal of study participation by the patient or the proxy 2. Anatomical factors precluding the use of a nasal cannula or CPAP 3. Long term oxygen 4. Home CPAP or NIV 5. Hypercapnia indicating NIV (PaCO2 \> 45 mmHg) 6. Isolated cardiogenic pulmonary oedema indicating NIV 7. Known pregnancy or breastfeeding 8. Absence of coverage by the French statutory health care insurance system 9. Surgery within the last 6 days 10. Use of vasopressors (norepinephrine\>0.3 mcg/kg/min) 11. Glasgow coma scale \< 13 12. Urgent need for endotracheal intubation 13. Patients at an end-of-life stage receiving compational oxygenation

Outcomes

Primary Outcomes

Mortality

Time to death within the 90 days after randomization

Time frame: 90 days

Secondary Outcomes

Time from randomization to intubation.

Time frame: 28 days

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

Respiratory rate

Time frame: 6, 12 and 24 hours

ROX index

Time frame: 6, 12 and 24 hours

Evaluation of intolerance to oxygenation technique until intubation

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

Time frame: 12 and 24 hours

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

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

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

1. the constitution of a clear indication such as acute-on-chronic respiratory failure with respiratory acidosis (pH \< 7.35) or acute cardiogenic pulmonary edema, 2. pre oxygenation before intubation, 3. fiberoptic bronchoscopy.

Time frame: through study completion

Death within the ICU

Time frame: through patient participation period,180 days maximum

Time to death

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

Death within the hospital and time to death.

Time frame: through patient participation period,180 days maximum

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

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.

Time frame: Between day 1 and day 28

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

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.

Time frame: Between day 1 and day 28.

ICU length of stay.

Time frame: through patient participation period,180 days maximum

Hospital length of stay.

Time frame: through patient participation period,180 days maximum

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

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.

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts