Bronchoscopy for Thoracic Trauma Patients

NCT06264856 | Suspended

• 1 other identifier: 202210096RIND
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Chest Trauma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Intensive Care Unit admission interval

  30 days

• admission interval

  up to 24 weeks (from randomization to discharge)

• tracheostomy rate

  up to 24 weeks (from randomization to discharge)

• intubation rate

  90 days

Study Arms (2)

bronchoscopic suction

EXPERIMENTAL

Bronchoscopic suction is a medical procedure used to remove excess mucus, secretions, and foreign objects from the airways through a bronchoscope. The patient would receive bronchoscopic sputum suction every 24-48 hrs after randomization until leaving ICU.. The patient could still receive blind negative pressure aspiration suction as the usual medical routine(every 2-4 hrs sputum suction if needed).

Procedure: bronchoscopic sputum suction

blind negative pressure aspiration suction

ACTIVE COMPARATOR

Negative pressure aspiration suction is a medical procedure that uses suction to remove fluids, mucus, or other materials from the body by creating a negative pressure or vacuum. 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 would receive blind negative pressure aspiration suction as the usual medical routine(every 2-4 hrs sputum suction if needed).

Procedure: negative pressure aspiration suction

Interventions

bronchoscopic sputum suction PROCEDURE

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.

bronchoscopic suction

negative pressure aspiration suction PROCEDURE

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.

blind negative pressure aspiration suction

Eligibility Criteria

• Age: 20 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (2)

Department of Traumatology, National Taiwain University Hospital

Taipei, 10002, Taiwan

Location

NTUH Hsin-Chu Branch; NTUH Yun-Lin Branch

Taipei, 100; 300; 640; 280, Taiwan

Location

MeSH Terms

Conditions

Thoracic Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Hsien-Chi Liao, MD

  Department of Traumatology, National Taiwain University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: February 20, 2024
• Study Start: December 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 20, 2024

Record last verified: 2023-04

Locations

TW (2)