Bronchoscopy for Thoracic Trauma Patients

Chest Trauma Clinical Trial

Official title:

Flexible-bronchoscopy Trial for Moderate and Severe Thoracic Trauma Patients Without Brain Injury

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT06264856
• Other study ID #: 202210096RIND
• Status: Suspended
• Phase: N/A
• Start date: December 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2023
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 60
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chest Trauma
• Thoracic Injuries
• Wounds and Injuries

Intervention

Procedure:
• bronchoscopic sputum suction
Bronchoscopy is a medical procedure in which a flexible tube called a bronchoscope is passed through the mouth or nose and into the lungs. Bronchoscopic suction is a technique used during bronchoscopy to remove secretions, mucus, or foreign objects from the airways. The bronchoscope is equipped with a suction port and a suction channel that allows the doctor to remove fluids or other material from the airways. The suction port is connected to a vacuum source, and the suction channel runs through the bronchoscope and terminates at the tip of the instrument.
• negative pressure aspiration suction
The procedure involves inserting a catheter into the airway and applying negative pressure to the catheter to suction out the secretions or fluids. The patient could receive sputum suction as medical routine (every 2-4 hrs) if needed.

Locations

Country	Name	City	State
Taiwan	Department of Traumatology, National Taiwain University Hospital	Taipei
Taiwan	NTUH Hsin-Chu Branch; NTUH Yun-Lin Branch	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of pneumonia	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.	30 days after randomization
Secondary	Intensive Care Unit admission interval	measure the time of total Intensive Care Unit admission interval	30 days
Secondary	admission interval	measure the time of total admission interval	up to 24 weeks (from randomization to discharge)
Secondary	tracheostomy rate	measure the rate of patient who receive tracheostomy in this admission	up to 24 weeks (from randomization to discharge)
Secondary	intubation rate	measure the rate of intubation rate	90 days