HFNC Compared With Facial Mask in Patients With Chest Trauma Patients

Not Applicable

Recruiting

• Conditions: Hypoxia; Chest Trauma
• Interventions: Procedure: high flow nasal cannula; Procedure: Oxygen mask

• Registration Number: NCT05828030
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-04-03
• Study First Submitted QC: 2023-04-13
• Study First Posted: 2023-04-25
• Study Start: 2023-04-26
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-15
• Last Update Posted: 2024-07-16
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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.)

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
high flow nasal cannula group	high flow nasal cannula	All patients will have FiO2 started at 0.4 and titrated to maintain oxygen saturation (SpO2) ≥ 95%. The flow rate will be set at titrated from 60 L/min.
Oxygen Mask group	Oxygen mask	All patients will have FiO2 started at 0.4 and titrated to maintain oxygen saturation (SpO2) ≥ 95%.

Primary Outcome Measures

Name	Time	Method
Rate of event of intubation or pneumonia	30 days after randomization	Intubation criteria included a respiratory rate of \>40 breaths per minute, signs of increased breathing effort, SpO2 of \<90% despite high fraction of inspired oxygen inspired oxygen fraction or acidosis with the quantitative measure of the acidity or basicity of aqueous or other liquid solutions (pH scale) of \<7.35, occurrence of hemodynamic instability or deterioration of neurologic status.

Secondary Outcome Measures

Name	Time	Method
P/F ratio	48 hrs after randomization	P/F ratio would be count at the time 0/4/12/24/48 hours after randomization
pneumonia rate /tracheostomy rate	30 days after randomization	diagnosis of pneumonia was determined according to radiologic evidence of new or progressive infiltrate of more than 48 hours and laboratory detection of a causative agent.; The management and diagnosis of all patients was performed by a trauma specialist.

Trial Locations

Locations (2)

Department of Traumatology, National Taiwain University Hospital; 🇨🇳 Taipei, Taiwan

NTUH Hsin-Chu Branch; NTUH Yun-Lin Branch; 🇨🇳 Taipei, Taiwan