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CompletedNCT06064773Updated Oct 3, 2023

Evaluation Of One Lung Ventilation With Ultrasound in Thorax Surgery Operations

An observational study in One Lung Ventilation, sponsored by Dokuz Eylul University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-10-03.

Sponsored by Dokuz Eylul University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
130
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • One Lung Ventilation

Keywords

  • One Lung Ventilation
  • Ultrasound
03

In context

Lead sponsor

Dokuz Eylul University is the lead sponsor of 252 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
130 participants (actual)
Target follow-up
1 Day
Patient registry
Yes

Interventions

  • Diagnostic testthoracic USG

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

06

What researchers measure

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

    Time frame: immediatelay after the Replacement of double lumen ETT

07

Study locations

1 site
  • Dokuz Eylul University
    İzmir, 35340, Turkey
08

References and documents

Publications

  • 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. Erratum In: BMC Anesthesiol. 2024 Jan 23;24(1):38. doi: 10.1186/s12871-024-02409-9. PubMed 35637457 ↗

Individual participant data

Plan to share: Undecided — If researchers ask for share then will be decided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06064773
Lead sponsor
Dokuz Eylul University
Responsible party
Hale Aksu (associate professor, Dokuz Eylul University) — Principal investigator
First posted
Oct 3, 2023
Start date
Jul 1, 2021
Primary completion
Dec 1, 2021
Completion
Dec 1, 2021
Last update
Oct 3, 2023

Study contacts

Hale Aksu
principal investigator · Associated prof

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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