Chest TraumaNCT06264856
Bronchoscopy for Thoracic Trauma Patients
A study testing bronchoscopic sputum suction and negative pressure aspiration suction in people with Chest Trauma, run by National Taiwan University Hospital at 2 sites in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 99 years
- Conditions the study is for
- Chest Trauma
- What is being tested?
- bronchoscopic sputum suction and negative pressure aspiration suction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesTaiwan
- Study dates
- 1 Dec 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Department of Traumatology, National Taiwain University Hospital
Taipei, 10002
NTUH Hsin-Chu Branch; NTUH Yun-Lin Branch
Taipei, 100; 300; 640; 280
About this study
Official title: Flexible-bronchoscopy Trial for Moderate and Severe Thoracic Trauma Patients Without Brain Injury
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.
Read the 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.
- Conditions
- Chest Trauma
- Being tested
- bronchoscopic sputum suction, negative pressure aspiration suction
- Medical subject headings
- Thoracic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bronchoscopic sputum suctionProcedure or surgery
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 suctionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Procedure: negative pressure aspiration suction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days after randomization
Secondary outcomes (4)
Intensive Care Unit admission interval
measure the time of total Intensive Care Unit admission interval
Measured: 30 days
admission interval
measure the time of total admission interval
Measured: up to 24 weeks (from randomization to discharge)
tracheostomy rate
measure the rate of patient who receive tracheostomy in this admission
Measured: up to 24 weeks (from randomization to discharge)
intubation rate
measure the rate of intubation rate
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 Dec 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Why it stopped: The principal investigator will be studying abroad for one year. The study is expected to resume enrollment from December 1, 2024.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chest TraumaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hsien-Chi Liao, MD, Principal investigator, Department of Traumatology, National Taiwain University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06264856
- Sponsor's protocol ID
- 202210096RIND
- Status last verified
- Apr 2023
- First submitted
- 3 Apr 2023
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flexible-bronchoscopy Trial for Moderate and Severe Thoracic Trauma Patients Without Brain Injury
- ClinicalTrials.gov ID
- NCT06264856
- Acronym / sponsor ID
- 202210096RIND
- Conditions
- Chest Trauma
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The principal investigator will be studying abroad for one year. The study is expected to resume enrollment from December 1, 2024.
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bronchoscopic suction | Experimental | Procedure: bronchoscopic sputum suctionBronchoscopic 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). |
| blind negative pressure aspiration suction | Active comparator | Procedure: negative pressure aspiration suctionNegative 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). |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bronchoscopic sputum suctionBronchoscopy 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. | Procedure or surgery | bronchoscopic suction |
| negative pressure aspiration suctionThe 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. | Procedure or surgery | blind negative pressure aspiration suction |
Primary outcome
Rate of pneumonia
Time frame: 30 days after randomization
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.
4 secondary outcomes
Intensive Care Unit admission interval
Time frame: 30 days
admission interval
Time frame: up to 24 weeks (from randomization to discharge)
tracheostomy rate
Time frame: up to 24 weeks (from randomization to discharge)
intubation rate
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hsien-Chi Liao, MD principal investigator
Department of Traumatology, National Taiwain University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bronchoscopic sputum suction and negative pressure aspiration suction in people with Chest Trauma, run by National Taiwan University Hospital at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of pneumonia (time frame: 30 days after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.