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 range18 Years

SexALL

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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.
✕. Consent is withdrawn.

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

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