NCT06799455

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
11mo left

Started Jun 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress51%
Jun 2025Mar 2027

First Submitted

Initial submission to the registry

January 23, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 29, 2025

Completed
4 months until next milestone

Study Start

First participant enrolled

June 2, 2025

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2027

Last Updated

June 5, 2025

Status Verified

June 1, 2025

Enrollment Period

1.8 years

First QC Date

January 23, 2025

Last Update Submit

June 3, 2025

Conditions

Multiple Pulmonary Diseases

Outcome Measures

Primary Outcomes (1)

  • Desaturation

    Whether a patient will experience any desaturation

    During the procedure

Study Arms (2)

uncuffed endotracheal group

EXPERIMENTAL
Device: Endotracheal tube

no endotracheal tube group/control

NO INTERVENTION

Interventions

Endotracheal tubeDEVICE

participants either receive the ETT during the procedure

uncuffed endotracheal group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any patient that is scheduled for EBUS-TBNA procedure

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

Study Officials

  • H. Erhan Dincer

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jamie Heisdorffer

CONTACT

curre024@umn.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Patient will be randomized 1:1 to UCETT vs no ETT (current standard procedure) when they scheduled for the EBUS-TBNA procedure.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2025

First Posted

January 29, 2025

Study Start

June 2, 2025

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Last Updated

June 5, 2025

Record last verified: 2025-06

Locations

US(1)