Recruiting

High Flow Nasal Cannula

Sponsor:

The Cooper Health System

Code:

NCT05203328

Conditions

Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Vapotherm

Regular nasal canula

Study Details

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.

Conditions

Lung Cancer

Study ID

NCT05203328

Start date

Feb 1, 2022

Status verified date

Sep, 2025

Completion date

May, 2026

Anticipated

Primary completion date

Mar, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • age>18 years
  • patient undergoing EBUS bronchoscopy with moderate conscious sedation.

Exclusion Criteria:

  • 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

Study Design

Enrollment

198 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: High flow nasal cannula oxygen

High flow nasal cannula oxygen will be provided during the procedure using a Vapotherm device

active comparator: Regular nasal cannula

Regular nasal cannula oxygen will be provided during the procedure

Interventions

Vapotherm

Monitored anesthesia care with oxygen supplementation through a high-flow nasal cannula

Regular nasal canula

Monitored anesthesia care with oxygen supplementation through a regular nasal cannula

Primary outcome measure

  • Number of interruption during EBUS procedure for hypoxia [ Time Frame: 1 day ]

Central Contacts and Locations

Central contacts

Wissam Abouzgheib, MD

(800) 826-6737Abouzgheib-Wissam@cooperhealth.edu

Locations

Cooper University Hospital

Recruiting

Camden, New Jersey, United States, 08103

Contacts

Wissam Abouzgheib, MD

800-826-6737abouzgheib-wissam@cooperhealth.edu

Christopher Ambrogi, DO

ambrogi-christopher@cooperhealth.edu

Principal Investigator:

Wissam Abouzgheib, MD

More Information

Sponsor

The Cooper Health System

Last update posted

Sep 25, 2025

Last verified

Sep, 2025

Keywords

  • EBUS
  • bronchoscopy
  • Vapotherm
  • high-flow nasal cannula
  • monitored anesthesia care (MAC)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cooper Health System on 2025-09-25.