HFNC Compared With Facial Mask in Patients With Chest Trauma Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-99
SponsorNational Taiwan University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.)
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
high flow nasal cannula
Procedure/Surgerythe patient receives HFNC after randomization. All patients will have FiO2 started at 0.4 and titrated to maintain oxygen saturation (SpO2) ≥ 95%.
Oxygen mask
Procedure/SurgeryAll patients will have FiO2 started at 0.4 and titrated to maintain oxygen saturation (SpO2) ≥ 95%.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: high flow nasal cannula groupExperimental treatment 1 intervention
Group B: Oxygen Mask groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Rate of event of intubation or pneumonia
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.
Time frame
30 days after randomizationSecondary outcomes
1
P/F ratio
P/F ratio would be count at the time 0/4/12/24/48 hours after randomization
Time frame
48 hrs after randomization2
pneumonia rate /tracheostomy rate
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.
Time frame
30 days after randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov