HFNC Compared With Facial Mask in Patients With Chest Trauma Patients

Официальное название

Noninvasive Ventilation With High Flow Nasal Cannula Compared With Facial Mask in Patients With Chest Trauma: a Randomized Controlled Study

Обзор

Guidelines for noninvasive ventilation (NIV) recommend continuous positive airway pressure in patients with thoracic trauma who remain hypoxic . However, no any suggestion was applied for high flow nasal cannula (HFNC). Therefore, Our aim was to determine whether HFNC reduces intubation in severe trauma-related hypoxemia.

Подробное описание

This would be a three-center randomized clinical trial of a level I trauma hospital. Inclusion criteria were patients with Arterial oxygen level (Pao2/)fraction of inspired oxygen inspired oxygen fraction(Fio2)\<300 while receiving oxygen by high-flow mask within the first 72 h after thoracic trauma. Patients were randomized to remain on high-flow oxygen mask/ noninvasive ventilation or to receive HFNC. The interface was selected based on the associated injuries.

Вмешательства

• Процедура high flow nasal cannula
  the patient receives HFNC after randomization. All patients will have FiO2 started at 0.4 and titrated to maintain oxygen saturation (SpO2) ≥ 95%.
• Процедура Oxygen mask
  All patients will have FiO2 started at 0.4 and titrated to maintain oxygen saturation (SpO2) ≥ 95%.

Первичные конечные точки

• Rate of event of intubation or pneumonia [Срок оценки: 30 days after randomization]

Вторичные конечные точки (2)

• P/F ratio [Срок оценки: 48 hrs after randomization]
• pneumonia rate /tracheostomy rate [Срок оценки: 30 days after randomization]

Критерии участия

Критерии включения

Patients who have the following condition within 72 hours of chest trauma despite receiving standard nasal cannula oxygen therapy \[≥10 L/min\], are eligible for inclusion.

• severe hypoxemic respiratory failure \[Arterial partial pressure of oxygen (PaO2)/fraction of inspired oxygen fraction(FiO2) <300 mmHg\]
• with a respiratory rate >25 breaths/minute and difficulty breathing, or respiratory distress
• PaCO2 of 45 mmHg or higher (if the patient requires emergency surgery with endotracheal intubation and mechanical ventilation, the time of inclusion will be the start of the post-extubation period. (Note: For patients who receive emergency trauma surgery with endotracheal intubation and mechanical ventilation, the time of inclusion assessment will be 72 hours after extubation.)

Критерии исключения

• Patients with a Glasgow Coma Scale less than 8 or severe brain injury.
• Patients with any contraindications to non-invasive ventilation, including acute gastrointestinal bleeding, upper airway obstruction, or hemodynamic instability.
• Facial trauma involving skull base fractures, facial bone fractures, or orbital floor fractures.
• Severe injuries involving the nasal sinuses.
• Patients with cervical spine injuries.
• Patients with increased intracranial pressure.
• Patients with facial, nasal, or airway structural abnormalities or surgery that prevents the use of appropriate nasal cannula.
• Patients after upper airway surgery.
• Patients who are unable to clearly express their willingness to sign informed consent.

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

Лечение

Центры проведения

Тайвань · 2 центра

• Department of Traumatology, National Taiwain University Hospital — Taipei
• NTUH Hsin-Chu Branch; NTUH Yun-Lin Branch — Taipei

Идентификаторы

NCT: NCT05828030 · 202211029DIND

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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