NCT06457763

Brief Summary

The aim of this study was to determine the accuracy and practicality of ultrasound in the selection of double lumen tube and whether the complications that may occur intraoperatively and postoperatively can be reduced. Patients aged 18-75 years with ASA 1-2-3 who give informed consent for left double lumen tube placement for single lung ventilation will be included in this study. Patients with a history of previous difficult intubation, head and neck surgery and radiotherapy, class 3-4 in the Colmark-Lehane classification by the thoracic anaesthetist who will perform the intubation, and patients with previously known hoarseness and chronic cough will not be included in the study. Patients who accept the study will be randomly assigned to one of the anaesthesia groups including ultrasound group (Group 1) and classical method (Group 2). Randomisation will be in a 1:1 ratio and will be done by closed envelope method.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

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

August 1, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 13, 2024

Completed
Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

1 month

First QC Date

May 29, 2024

Last Update Submit

February 15, 2026

Conditions

Keywords

UltrasoundDouble lumen tubePostoperative complication

Outcome Measures

Primary Outcomes (1)

  • postoperative cough and sore throat

    Zero: No sore throat; 1: Mild, sore throat only when swallowing; 2: Moderate, persistent sore throat, aggravated when swallowing; 3: Severe, throat pain affecting the patient's eating, and analgesic drugs were needed

    postoperative first at 24 hours

Study Arms (2)

Ultrasound

ACTIVE COMPARATOR

While the patients were in the supine position on the operating room table, the external tracheal diameter, measured just above the sternoclavicular junction, was measured by ultrasound. Appropriately sized tube size was selected in accordance with previous studies and cadaver studies.

Other: Ultrasound

conventional

ACTIVE COMPARATOR

For female patients, a 37 fr left double lumen tube was chosen for patients taller than 160 cm, and a 35 fr left double lumen tube was chosen for patients shorter than 160 cm. For male patients, a 41 fr left double lumen tube was selected for patients taller than 170 cm and a 39 fr tube was chosen for men shorter than 170 cm.

Other: Ultrasound

Interventions

with ultrasound meauser

Ultrasoundconventional

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who will place a left double lumen tube to perform one lung ventilation
  • Between the ages of 18-75
  • ASA 1-2-3 patients

You may not qualify if:

  • Patients with a previous history of difficult intubation
  • Patients who have previously undergone head and neck surgery or received radiotherapy
  • Patients with a Cormark-Lehane classification of 3-4 by the thoracic anaesthetist performing intubation,
  • Patients with previous cough and sore throat

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University

Istanbul, Maltepe, 34854, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Postoperative Complications

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

May 29, 2024

First Posted

June 13, 2024

Study Start

August 1, 2023

Primary Completion

September 1, 2023

Study Completion

May 29, 2024

Last Updated

February 18, 2026

Record last verified: 2026-02

Locations