WithdrawnNot Applicable

Evaluation of Leak-Free Bronchoscope Adapter to Limit Ventilated Air Volume Loss During Bronchoscopy

Stopped: No participants enrolled

United States0Started 2024-01-17

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of participants able to undergo bronchoscopic evaluation using the "leak-free adapter"

Timeframe: During the bronchoscopy procedure

Heart rate (bpm)

Timeframe: Immediately before the procedure and during the procedure

Blood pressure (mmHg)

Timeframe: Immediately before the procedure and during the procedure

Oxygenation as measured by SpO2

Timeframe: Immediately before the procedure and during the procedure

Assessment of adverse events

Timeframe: During the procedure and immediately after the procedure

Trial details

NCT IDNCT06310577

SponsorEndeavor Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11

View on ClinicalTrials.gov More Pulmonary Disease trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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

Exclusion criteria

. 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.

What they're measuring

Number of participants able to undergo bronchoscopic evaluation using the "leak-free adapter"

Timeframe: During the bronchoscopy procedure

Heart rate (bpm)

Timeframe: Immediately before the procedure and during the procedure

Blood pressure (mmHg)

Timeframe: Immediately before the procedure and during the procedure

Oxygenation as measured by SpO2

Timeframe: Immediately before the procedure and during the procedure

Assessment of adverse events

Timeframe: During the procedure and immediately after the procedure