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.

Официальное название

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

Обзор

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

Вмешательства

• Другое HFNC
  Patients assigned to the control group will be continuously treated by HFNC. HFNC will be initiated within one hour following randomization
• Другое CPAP and HFNC
  Patients assigned to the intervention group will receive high flow nasal oxygen plus CPAP sessions

Первичные конечные точки

• Mortality [Срок оценки: 90 days]

Вторичные конечные точки (12)

• Time from randomization to intubation. [Срок оценки: 28 days]
• Intensity of dyspnea until intubation as assessed by a visual analogic scale from zero (no dyspnea) to 100 (maximum possible dyspnea). [Срок оценки: 2, 6, 12 and 24 hours]
• Respiratory rate [Срок оценки: 6, 12 and 24 hours]
• ROX index [Срок оценки: 6, 12 and 24 hours]
• Evaluation of intolerance to oxygenation technique until intubation [Срок оценки: 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). [Срок оценки: 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). [Срок оценки: First 24 hours or until intubation]
• Use of NIV for one of the following predefined indication criteria. [Срок оценки: through study completion]
• Death within the ICU [Срок оценки: through patient participation period,180 days maximum]
• Time to death [Срок оценки: through patient participation period, an average of 180 days maximum]
• Death within the hospital and time to death. [Срок оценки: through patient participation period,180 days maximum]
• Number of invasive ventilation-free days at 28 days defined as days alive and without intubation. [Срок оценки: Between day 1 and day 28]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

Франция · 29 центров

• CHU Amiens-Picardie — Amiens
• CHU Angers — Angers
• Centre Hospitalier Victor Dupouy — Argenteuil
• Hôpital Avicenne — Bobigny
• Centre Hospitalier de Bourg-en-Bresse - Site de Fleyriat — Bourg-en-Bresse
• Hôpital Louis-Mourier — Colombes
• Centre Hospitalier Sud Francilien — Corbeil-Essonnes
• Hôpital Henri-Mondor — Créteil
• … и ещё 21 центр

Идентификаторы

NCT: NCT06213168 · APHP220813

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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