NCT07107893

Brief Summary

The aim of this study was to compare auscultation, fiberoptic bronchoscopy (FOB) and video double lumen tube (VDLT) double lumen tube (DLT) location confirmation techniques in terms of intraoperative tube location confirmation time, number of tube dislocations, correction time of dislocations, FOB usage rates, lung deflation quality, postoperative sore throat, presence of hoarseness and cost in thoracic surgery patients undergoing one lung ventilation (OLV).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
93

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

January 16, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2025

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 6, 2025

Completed
Last Updated

August 6, 2025

Status Verified

August 1, 2025

Enrollment Period

3 months

First QC Date

July 17, 2025

Last Update Submit

August 3, 2025

Conditions

Keywords

Double lumen tube with videoSingle lung ventilation

Outcome Measures

Primary Outcomes (1)

  • verification of tube location

    The primary endpoint is the identification of a method that allows the quickest confirmation of double-lumen tube location after intubation and possible intraoperative location changes.

    during surgery

Secondary Outcomes (1)

  • evaluation of complications

    during surgery

Other Outcomes (1)

  • cost effectiveness

    during surgery

Study Arms (3)

grup I

Group with confirmed tube location by auscultation

Grup II

Group with confirmed tube location by fiberoptic bronchoscope

Grup III

The group in which double lumen tube with video was used

Device: double lumen tube with video

Interventions

Methods used to confirm tube placement in one-lung ventilation: auscultation, fiberoptic bronchoscopy, and video to evaluate double-lumen tube use

Also known as: fiberoptic bronchoscope
Grup III

Eligibility Criteria

Age18 Years - 84 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Ninety-three patients who would undergo thoracic surgery with single-lung ventilation at the Health Sciences University Kayseri City Training and Research Hospital Anesthesiology and Reanimation Clinic were evaluated for suitability.

You may qualify if:

  • Patients who will undergo TAV and be placed in the lateral position.
  • Patients with ASA scores of I-III.
  • Patients aged 18-84.

You may not qualify if:

  • Patients undergoing emergency surgery
  • Patients with American Society of Anesthesiology (ASA) IV and above
  • Patients with anticipated difficult intubation
  • Patients requiring intubation with a right thoracic duct (CLT)
  • Patients with more than three intubation attempts
  • Patients who refuse to participate in the study
  • Patients who will undergo TAV but will not be placed in the lateral position (sympathectomy)
  • Patients with uncontrolled metabolic disease
  • Mentally retarded patients
  • Patients under 18 or over 84
  • Patients with tracheal or airway abnormalities
  • Pregnant or breastfeeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kayseri Şehir Hastanesi

Kayseri, Kocasinan, 38080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lung NeoplasmsLung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant doctor of anesthesiology and reanimation

Study Record Dates

First Submitted

July 17, 2025

First Posted

August 6, 2025

Study Start

January 16, 2025

Primary Completion

April 15, 2025

Study Completion

April 30, 2025

Last Updated

August 6, 2025

Record last verified: 2025-08

Locations