Uncuffed Endotracheal Tube vs. no Endotracheal Tube

June 3, 2025 updated by: University of Minnesota

Comparison of Uncuffed Endotracheal Tube to no Endotracheal Tube in EBUS-TBNA Procedure Under Moderate Sedation

This is a comparison of uncuffed endotracheal tube (UCETT) vs. no endotracheal tube (ETT) in endobronchial ultrasound-transbronchial needle aspiration (EBUS-TBNA) procedure under moderate sedation in terms of procedure tolerance, duration of the procedure, desaturation, amount of sedation medication usage.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Any patient that is scheduled for EBUS-TBNA procedure

Exclusion Criteria:

  • Those who are not safe to receive moderate sedation or flexible bronchoscopy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: uncuffed endotracheal group
Device: Endotracheal tube
participants either receive the ETT during the procedure
No Intervention: no endotracheal tube group/control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Desaturation
Time Frame: During the procedure
Whether a patient will experience any desaturation
During the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

  • Principal Investigator: H. Erhan Dincer, University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2025

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

January 23, 2025

First Submitted That Met QC Criteria

January 23, 2025

First Posted (Actual)

January 29, 2025

Study Record Updates

Last Update Posted (Estimated)

June 5, 2025

Last Update Submitted That Met QC Criteria

June 3, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PACCS-2024-33033

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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