Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06310577
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-02-19
Brief Title:
Evaluation of Leak-Free Bronchoscope Adapter to Limit Ventilated Air Volume Loss During Bronchoscopy
Sponsor:
NorthShore University HealthSystem
Organization:
NorthShore University HealthSystem
Study Overview
Official Title:
Evaluation of Leak-free Bronchoscope Adapter to Limit Ventilated Air Volume Loss and Aerosolization From Intubated Patients Who Undergo Bronchoscopy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Bronchoscopy is a commonly performed procedure where a camera tipped device is used to look into a patients lung To perform bronchoscopy a standard commercial adapter is connected to the ventilator tubing which lets the doctors use the bronchoscopeThe 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None