Evaluation Of One Lung Ventilation With Ultrasound in Thorax Surgery Operations

September 26, 2023 updated by: Hale Aksu, Dokuz Eylul University

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.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

This prospective observational study was carried out in the Department of Anesthesiology and Reanimation, with the permission of the Ethics Committee of Dokuz Eylul University Medical Faculty Hospital (Ethics Committee Decision No:2021/17-04). Between 01.07.2021 and 01.12.2021, cases requiring single-lung ventilation by thoracic surgery in the operating room of Dokuz Eylul University Faculty of Medicine were included in the study.

Over 18 years old, patients who need OLV and undergoing elective surgery was determined as inclusion criteria. Furthermore patients did not want to participate in the study, with a narrowed trachea and/or a narrowed main bronchus that does not allow DLT placement, 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 and patients who will undergo emergency surgery determined as exclusion criteria for the study.

On the day of surgery, all patients were premedicated after a 20 G cannula was placed on the back of the hand before they were taken to the operating room. Routine anesthesia induction was performed after preoxygenation with 100% O2 for 5 minutes by monitoring 3-lead electrocardiography, peripheral oxygen saturation and noninvasive blood pressure in the patients who were taken to the operating room. After anesthesia induction, patients underwent double lumen tube intubation and after confirming single lung ventilation with thoracic USG (GE Healthcare LOGIQ e), tube location was confirmed by fiberoptic bronchoscopy (FOB) and clinical evaluation and recorded. Slip sign on USG was evaluated with M-mode imaging in the right and left lower quadrants of the thorax at the level of the costophrenic angles. When the bronchial lumen was clamped, the tube was considered to be positioned correctly if the left shift sign was selectively lost.

Age, gender, body mass index (BMI), AmericanSociety of Anesthesiologists score, co-morbidities (Hypertension, diabetes mellitus, malignancy, chronic obstructive pulmonary disease) duration of surgery, clinical and FOB evaluation results of the patients included in the study, in the supine position and in the lateral position during the intraoperative period. The determined DLT malpositions and the manipulations performed to correct them and the results of the evaluation with the thorax USG method, as well as the intraoperative surgeon satisfaction were recorded by the doctor who followed the case.

Study Type

Observational

Enrollment (Actual)

130

Contacts and Locations

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

Study Locations

      • İzmir, Turkey, 35340
        • Dokuz Eylül University

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

Sampling Method

Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thoracic USG sensitive and specificity values
Time Frame: immediatelay after the Replacement of double lumen ETT
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

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Hale Aksu, Associated prof

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

July 1, 2021

Primary Completion (Actual)

December 1, 2021

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

September 19, 2023

First Submitted That Met QC Criteria

September 26, 2023

First Posted (Actual)

October 3, 2023

Study Record Updates

Last Update Posted (Actual)

October 3, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2021/17-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

If researchers ask for share then will be decided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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