Prospective Study to Evaluate High Flow Nasal Cannula With Monitored Anesthesia Care During EBUS Bronchoscopy
1 other identifier
interventional
198
1 country
1
Brief Summary
Our objective is to assess whether the use of high flow nasal cannula (Vapotherm, Exeter, NH) with monitored anesthesia care (MAC) during an endobronchial ultrasound (EBUS) bronchoscopy procedure will lead to less procedure interruptions, less hypoxic episodes, shorter duration of hypoxic episodes and shorter procedural durations when compared to regular MAC using a regular nasal canula.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable lung-cancer
Started Feb 2022
Typical duration for not_applicable lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 29, 2021
CompletedFirst Posted
Study publicly available on registry
January 24, 2022
CompletedStudy Start
First participant enrolled
February 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedSeptember 25, 2025
September 1, 2025
4.1 years
November 29, 2021
September 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of interruption during EBUS procedure for hypoxia
We will count the number of interruptions during EBUS procedure for hypoxia
1 day
Study Arms (2)
High flow nasal cannula oxygen
EXPERIMENTALHigh flow nasal cannula oxygen will be provided during the procedure using a Vapotherm device
Regular nasal cannula
ACTIVE COMPARATORRegular nasal cannula oxygen will be provided during the procedure
Interventions
Monitored anesthesia care with oxygen supplementation through a high-flow nasal cannula
Monitored anesthesia care with oxygen supplementation through a regular nasal cannula
Eligibility Criteria
You may qualify if:
- age\>18 years
- patient undergoing EBUS bronchoscopy with moderate conscious sedation.
You may not qualify if:
- subjects with previous nasal surgeries
- subjects with oxygen saturation \<90% on room air prior to procedure
- subjects who are pregnant
- subjects with known facial fractures or recent facial trauma
- subjects on any anticoagulation that cannot be discontinued prior to the procedure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cooper University Hospital
Camden, New Jersey, 08103, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 29, 2021
First Posted
January 24, 2022
Study Start
February 1, 2022
Primary Completion
March 1, 2026
Study Completion
May 1, 2026
Last Updated
September 25, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share