Clinical trial NCT06264856: Bronchoscopy for Thoracic Trauma Patients
Official title: Flexible-bronchoscopy Trial for Moderate and Severe Thoracic Trauma Patients Without Brain Injury
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Chest Trauma
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to evaluate the effectiveness of bronchoscopic sputum suction in patients with severe thoracic illness-induced respiratory failure. The study will compare the outcomes of patients who receive bronchoscopic sputum suction versus blind negative pressure aspiration for sputum removal. The study will measure baseline data, postoperative blood gas conditions, and clinical parameters, such as time of invasive ventilation, total time of ventilation, hospital stay, weaning success rate, reintubation rate, ventilator-associated pneumonia incidence, and fatality rate. The study aims to determine whether bronchoscopy-assisted sputum removal is superior to blind negative pressure aspiration in improving patient outcomes.

Detailed description: The aim of the present randomized control trial is to assess the value of bronchoscopic sputum suction in patients with severe thoracic illness-induced respiratory failure. To decrease group differences in baseline characteristics and blood gas conditions, patients will be randomly assigned to receive either bronchoscopy-assisted or negative pressure aspiration for sputum suction, while the remaining treatment course will be the same. The study will measure major clinical indicators such as time of invasive ventilation, total time of ventilation, hospital stay, weaning success rate, reintubation rate, ventilator-associated pneumonia incidence, and fatality rate to provide strong evidence for the efficacy of each suction method.

Eligibility criteria: Inclusion Criteria:

* Participants must be 20 years of age or older.
* Participants of all genders are eligible.
* Participants who are not in good health are not eligible.
* Participants with an Injury Severity Score greater than 9 and who have chest trauma are eligible.

Exclusion Criteria:

* Patients with traumatic brain injury.
* Patients with active pulmonary tuberculosis or other respiratory diseases with suspected contagion.
* Patients with poor blood clotting function or a tendency to bleed.
* Patients with aortic aneurysm. Patients with unstable vital signs or those who cannot maintain oxygen saturation above 90% while performing the test with Fraction of Inspired Oxygen (FiO2) greater than 80% or on 100% oxygen.
* Immunocompromised patients.
* Patients with acute massive hemoptysis.
* Patients with pre-existing neuromuscular diseases or those at high risk for arrhythmias, myocardial ischemia, or pulmonary embolism.
* Patients who are unable to clearly express their willingness to sign the informed consent form.
* Patients who have frequent intermittent sputum suction or are unable to fast for 4 hours due to their medical condition.

Primary outcomes:
measure: Rate of pneumonia
timeFrame: 30 days after randomization
Secondary outcomes:
measure: Intensive Care Unit admission interval
timeFrame: 30 days
measure: admission interval
timeFrame: up to 24 weeks (from randomization to discharge)
measure: tracheostomy rate
timeFrame: up to 24 weeks (from randomization to discharge)
measure: intubation rate
timeFrame: 90 days
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Traumatology, National Taiwain University Hospital
city: Taipei
country: Taiwan
facility: NTUH Hsin-Chu Branch; NTUH Yun-Lin Branch
Study officials:
affiliation: Department of Traumatology, National Taiwain University Hospital
name: Hsien-Chi Liao, MD
role: PRINCIPAL_INVESTIGATOR
References: