Benefits of noninvasive continuous positive airway pressure ventilation (NIV-CPAP) for severe blunt chest injuries: A randomized controlled study

Phase 1

Completed

• Conditions: Several studies have suggested that non-invasive ventilator reduced mortality and intubation rate in respiratory failure. However, the benefits of NIV-CPAP for the management of severe blunt chest trauma are still controversial.; Noninvasive ventilator continuous positive airway pressure, blunt chest injury, thoracic trauma severity score

• Registration Number: TCTR20211025006
• Lead Sponsor: Faculty of Medicine Siriraj Hospital Mahidol University

Brief Summary

The results of this study suggested that early use of NIV-CPAP was potential to be useful in the management of severe traumatic blunt chest injury patients, reduce intubation rate and improve oxygenation. However, the trial was prematurely stopped due to significant higher rate of intubation in the control group.

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-07-19
• Study Start: 2021-10-25
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Between 18 - 65 years old concomitant with blunt chest injury, patent airway in the first seen
2. Trauma thoracic severity score between 5 - 15 points or chest abbreviated injury scale (AIS) more than 3 points

Exclusion Criteria

1. Included moderate to severe hypoxemia (PaO2 < 65 mmHg or SpO2 < 90 % at room air)
2. Required emergency surgery following admission
3. Required endotracheal tube intubation immediately on admission
4. Uncooperative patients
5. Severe mid facial injury which was not suitable for applying the face mask
6. Hypercarbia (PaCO2 > 45 mm Hg)
7. Severe acidosis with pH < 7.2
8. Hemodynamic instability after proper resuscitation
9. Significant co-morbidity (cerebrovascular accident, recent coronary arterial disease, poor control diabetic mellitus, end stage renal disease)
10. Claustrophobic or oronasal mask intolerance
11. Contraindication for epidural analgesia or other analgesic agents

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the intubation rate at 12 months after end of the intervention Chi square or Fisher exact test

Secondary Outcome Measures

Name	Time	Method
length of ICU stay at 12 months after end of the intervention t-test and Mann-Whitney U test logistic regression