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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| high flow nasal cannula group | Experimental | 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 | Active Comparator | All patients will have FiO2 started at 0.4 and titrated to maintain oxygen saturation (SpO2) ≥ 95%. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| high flow nasal cannula | Procedure | the patient receives HFNC after randomization. All patients will have FiO2 started at 0.4 and titrated to maintain oxygen saturation (SpO2) ≥ 95%. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| P/F ratio | P/F ratio would be count at the time 0/4/12/24/48 hours after randomization | 48 hrs after randomization |
| 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. |
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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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hsien-Chi Liao, MD | Contact | +886-972651611 | polarisliao@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hsien-Chi Liao, MD | department of trauma of National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Traumatology, National Taiwain University Hospital | Recruiting | Taipei | Taipei | 10002 | Taiwan |
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| ID | Term |
|---|---|
| D013898 | Thoracic Injuries |
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Oxygen mask | Procedure | All patients will have FiO2 started at 0.4 and titrated to maintain oxygen saturation (SpO2) ≥ 95%. |
|
| 30 days after randomization |
| NTUH Hsin-Chu Branch; NTUH Yun-Lin Branch | Recruiting | Taipei | Taiwan | 100; 300; 640; 280 | Taiwan |
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