NCT06064773

Brief Summary

BACKGROUND: The aim of this study is to evaluate the confirmation of double lumen tube placement with thoracic Ultrasound (USG) in thorax surgery operations with one lung ventilation. METHODS: In this prospective and observational study, 130 patients aged between 18-65 years in ASA (American Society of Anesthesiology) I-III risk class who will undergo thoracic surgery with the application of single-lung ventilation were included in the study. A double-lumen endobronchial tube was placed in the patients blindly. One-lung ventilation (OLV) was confirmed by thoracic USG by the anesthesiologist. The patient's demographic data, rapid clinical evaluation and USG data results, and intraoperative surgeon satisfaction were recorded.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 3, 2023

Completed
Last Updated

October 3, 2023

Status Verified

September 1, 2023

Enrollment Period

5 months

First QC Date

September 19, 2023

Last Update Submit

September 26, 2023

Conditions

Keywords

One Lung VentilationUltrasound

Outcome Measures

Primary Outcomes (1)

  • Thoracic USG sensitive and specificity values

    confirmation of DLT location with thorax USG in thoracic surgery operations in which Single Lung ventilation was applied, sensitive and specificity values

    immediatelay after the Replacement of double lumen ETT

Interventions

thoracic USGDIAGNOSTIC_TEST

the confirmation of double lumen tube placement with thoracic USG in thoracic surgery operations with one lung ventilation.

Eligibility Criteria

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

Over 18 years old, patients who need OLV and undergoing elective surgery

You may qualify if:

  • Over 18 years old, patients
  • who need OLV and undergoing elective surgery

You may not qualify if:

  • patients did not want to participate in the study,
  • with a narrowed trachea and/or a narrowed main bronchus
  • with endobronchial lesion in the main bronchus,
  • with subcutaneous emphysema,
  • having a chest tube due to pneumothorax,
  • with pleural effusion,
  • having a history of pleurodesis,
  • bullous lung,
  • patients with a history of tracheostomy
  • patients who will undergo emergency surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylul University

Izmir, 35340, Turkey (Türkiye)

Location

Related Publications (1)

  • Kanavitoon S, Raksamani K, Troy MP, Suphathamwit A, Thongcharoen P, Suksompong S, Oh SS. Lung ultrasound is non-inferior to bronchoscopy for confirmation of double-lumen endotracheal tube positioning: a randomized controlled noninferiority study. BMC Anesthesiol. 2022 May 30;22(1):168. doi: 10.1186/s12871-022-01707-4.

Study Officials

  • Hale Aksu

    Associated prof

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

September 19, 2023

First Posted

October 3, 2023

Study Start

July 1, 2021

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

October 3, 2023

Record last verified: 2023-09

Locations