Pulmonary DiseaseNCT06310577
Evaluation of Leak-Free Bronchoscope Adapter to Limit Ventilated Air Volume Loss During Bronchoscopy
A study testing Leak-free bronchoscope adapter in people with Pulmonary Disease, run by Endeavor Health at 1 site in United States.
Trial summary
The purpose of this research is to evaluate the ability of a new bronchoscope adapter called "leak-free adapter" to limit the amount of air leaking out to the operating room (OR) from the ventilator in intubated patients who undergo bronchoscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Disease
- What is being tested?
- Leak-free bronchoscope adapter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2024to Nov 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who will be undergoing elective intubation for either a surgical or bronchoscopic procedure (diagnostic or therapeutic)
- Both males and females
- Adults 18 years and older
Who cannot join
- Significant protocol deviation
- Significant non-compliance with protocol or study requirements
- An adverse event which requires discontinuation which results in the inability to continue to comply with study procedures.
- Consent is withdrawn.
Trial locations and contacts
1 site in 1 country.
United States1 site
NorthShore University HealthSystem
Chicago, Illinois, 60201
About this study
Official title: Evaluation of Leak-free Bronchoscope Adapter to Limit Ventilated Air Volume Loss and Aerosolization From Intubated Patients Who Undergo Bronchoscopy
The purpose of this research is to evaluate the ability of a new bronchoscope adapter called "leak-free adapter" to limit the amount of air leaking out to the operating room (OR) from the ventilator in intubated patients who undergo bronchoscopy.
Read the detailed description
Bronchoscopy is a commonly performed procedure where a camera tipped device is used to look into a patient's lung. To perform bronchoscopy, a "standard commercial adapter" is connected to the ventilator tubing, which lets the doctors use the bronchoscope.The design of the "standard commercial adapter" can cause about 20% of air to escape from the ventilator to the OR. This leaked air causes two issues: first, this can lead to lower oxygen levels and can limit the amount of time your physician can perform bronchoscopy. Second, the leaked air can lead to the spread of harmful particles like anesthesia gas to the OR. These particles can harm the staff in the operating room or spread to other patients in the hospital.
This study will compare the benefit of the "standard commercial adapter" to the newly developed "leak-free adapter". The investigational procedure being studied here is repeating the bronchoscopy with the leak-free adapter. Outcomes (which measure the benefit of the new adapter) will be measured for each adapter independently. Bronchoscopy using both devices will be performed by the physician performing the procedure.
- Conditions
- Pulmonary Disease
- Being tested
- Leak-free bronchoscope adapter
- Keywords
- Bronchoscope adapter
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leak-free bronchoscope adapterDevice
Bronchoscopy using both a standard adapter and a leak-free adapter will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Leak free bronchoscope adapter | Experimental | As a standard part of procedure, bronchoscopy will be performed using the "standard commercial adapter". Following the standard bronchoscope adapter use, leak-free bronchoscope adapter will be tested to compare the amount, and quality of air leaked between the"standard commercial adapter" and the "leak-free adapter. Receives: Device: Leak-free bronchoscope adapter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants able to undergo bronchoscopic evaluation using the "leak-free adapter"
Assessment of the capacity to complete the full bronchoscopic procedure using the "leak-free adapter" device.
Measured: During the bronchoscopy procedure
Heart rate (bpm)
Prior to the initiation of the bronchoscopic procedure, the patient's will heart rate will be recorded. These values will be continuously monitored and recorded throughout the bronchoscopic procedure.
Measured: Immediately before the procedure and during the procedure
Blood pressure (mmHg)
Prior to the initiation of the bronchoscopic procedure, the patient's blood pressure will be recorded. These values will be continuously monitored and recorded throughout the bronchoscopic procedure.
Measured: Immediately before the procedure and during the procedure
Oxygenation as measured by SpO2
Quantification and comparison of patient oxygenation using the "leak-free bronchoscope adapter" vs. the "standard commercial adapter". A pulse oximeter will be used to measure the patient's oxygen saturation (SpO2). Prior to bronchoscopy, the patients circulating oxygen saturation will be recorded during 10 ventilated breaths. Upon initiation of bronchoscopy, the SpO2 level will be measured throughout the procedure.
Measured: Immediately before the procedure and during the procedure
Assessment of adverse events
Any adverse events related to the leak-free adapter use will be evaluated.
Measured: During the procedure and immediately after the procedure
Secondary outcomes (4)
Evaluation of bronchoscope adapter tidal volume loss efficacy
Quantification and comparison of the proportion of tidal volume delivered to a patient by the ventilator during bronchoscopy using the "leak-free bronchoscope adapter" vs. the "standard commercial adapter".
Measured: During the bronchoscopy procedure
Evaluation of bronchoscope adapter aerosolization efficacy
Quantification and comparison of aerosolized gas delivered to the ambient environment by the ventilator during bronchoscopy using the "leak-free bronchoscope adapter" vs. the "standard commercial adapter".
Measured: During the bronchoscopy procedure
Peak airway pressure (cmH2O)
Quantification and comparison of pulmonary pressure parameters by the ventilator during bronchoscopy. Peak airway pressure (cmH2O) will be obtained from ventilator during bronchoscopy using the "leak-free bronchoscope adapter" vs. the "standard commercial adapter".
Measured: During the bronchoscopy procedure
Dynamic compliance (mL/CmH2O)
Quantification and comparison of pulmonary pressure parameters by the ventilator during bronchoscopy. Dynamic compliance (mL/CmH2O) will be obtained from ventilator during bronchoscopy using the "leak-free bronchoscope adapter" vs. the "standard commercial adapter".
Measured: During the bronchoscopy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start17 Jan 2024 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Why it stopped: No participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary DiseaseStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Self-controlled
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Su, Endeavor Health
- Investigators
- Katherine Su, MD, Principal investigator, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06310577
- Sponsor's protocol ID
- EH23-343
- Status last verified
- Dec 2025
- First submitted
- 19 Feb 2024
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Leak-free Bronchoscope Adapter to Limit Ventilated Air Volume Loss and Aerosolization From Intubated Patients Who Undergo Bronchoscopy
- ClinicalTrials.gov ID
- NCT06310577
- Acronym / sponsor ID
- EH23-343
- Conditions
- Pulmonary Disease
- Keywords
- Bronchoscope adapter
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Study start
- 17 Jan 2024 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 15 Mar 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 purpose of this research is to evaluate the ability of a new bronchoscope adapter called "leak-free adapter" to limit the amount of air leaking out to the operating room (OR) from the ventilator in intubated patients who undergo bronchoscopy.
Detailed description
Bronchoscopy is a commonly performed procedure where a camera tipped device is used to look into a patient's lung. To perform bronchoscopy, a "standard commercial adapter" is connected to the ventilator tubing, which lets the doctors use the bronchoscope.The design of the "standard commercial adapter" can cause about 20% of air to escape from the ventilator to the OR. This leaked air causes two issues: first, this can lead to lower oxygen levels and can limit the amount of time your physician can perform bronchoscopy. Second, the leaked air can lead to the spread of harmful particles like anesthesia gas to the OR. These particles can harm the staff in the operating room or spread to other patients in the hospital.
This study will compare the benefit of the "standard commercial adapter" to the newly developed "leak-free adapter". The investigational procedure being studied here is repeating the bronchoscopy with the leak-free adapter. Outcomes (which measure the benefit of the new adapter) will be measured for each adapter independently. Bronchoscopy using both devices will be performed by the physician performing the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Self-controlled
| Arm | Type | Receives |
|---|---|---|
| Leak free bronchoscope adapter | Experimental | Device: Leak-free bronchoscope adapterAs a standard part of procedure, bronchoscopy will be performed using the "standard commercial adapter". Following the standard bronchoscope adapter use, leak-free bronchoscope adapter will be tested to compare the amount, and quality of air leaked between the"standard commercial adapter" and the "leak-free adapter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants who will be undergoing elective intubation for either a surgical or bronchoscopic procedure (diagnostic or therapeutic)
- Both males and females
- Adults 18 years and older
Key exclusion criteria (4 listed)
- Significant protocol deviation
- Significant non-compliance with protocol or study requirements
- An adverse event which requires discontinuation which results in the inability to continue to comply with study procedures.
- Consent is withdrawn.
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 |
|---|---|---|
| Leak-free bronchoscope adapterBronchoscopy using both a standard adapter and a leak-free adapter will be performed. | Device | Leak free bronchoscope adapter |
Primary outcome
Number of participants able to undergo bronchoscopic evaluation using the "leak-free adapter"
Time frame: During the bronchoscopy procedure
Assessment of the capacity to complete the full bronchoscopic procedure using the "leak-free adapter" device.
Heart rate (bpm)
Time frame: Immediately before the procedure and during the procedure
Prior to the initiation of the bronchoscopic procedure, the patient's will heart rate will be recorded. These values will be continuously monitored and recorded throughout the bronchoscopic procedure.
Blood pressure (mmHg)
Time frame: Immediately before the procedure and during the procedure
Prior to the initiation of the bronchoscopic procedure, the patient's blood pressure will be recorded. These values will be continuously monitored and recorded throughout the bronchoscopic procedure.
Oxygenation as measured by SpO2
Time frame: Immediately before the procedure and during the procedure
Quantification and comparison of patient oxygenation using the "leak-free bronchoscope adapter" vs. the "standard commercial adapter". A pulse oximeter will be used to measure the patient's oxygen saturation (SpO2). Prior to bronchoscopy, the patients circulating oxygen saturation will be recorded during 10 ventilated breaths. Upon initiation of bronchoscopy, the SpO2 level will be measured throughout the procedure.
Assessment of adverse events
Time frame: During the procedure and immediately after the procedure
Any adverse events related to the leak-free adapter use will be evaluated.
4 secondary outcomes
Evaluation of bronchoscope adapter tidal volume loss efficacy
Time frame: During the bronchoscopy procedure
Evaluation of bronchoscope adapter aerosolization efficacy
Time frame: During the bronchoscopy procedure
Peak airway pressure (cmH2O)
Time frame: During the bronchoscopy procedure
Dynamic compliance (mL/CmH2O)
Time frame: During the bronchoscopy procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2025.
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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.
Katherine Su, MD principal investigator
Endeavor Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leak-free bronchoscope adapter in people with Pulmonary Disease, run by Endeavor Health at 1 site in United States.
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 3 inclusion and 4 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: withdrawn, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Number of participants able to undergo bronchoscopic evaluation using the "leak-free adapter" (time frame: During the bronchoscopy procedure). The study lists 5 primary outcomes in all. 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 30 Dec 2025.