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Completed

NCT Number: NCT03314519

Lung Ultrasonography vs Fiberoptic Bronchoscopy for Aiding Lung Collapse in Patient Using Double Lumen Tube

The study contains the result from a comparison of diagnostic outcomes about lung collapse by using lung ultrasonography as a new diagnostic test compares to fiberoptic bronchoscopy as the standard test.

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Key information

Conditions

Lung Diseases Fiberoptic Bronchoscopy Lung Collapse One Lung Ventilation Pulmonary Atelectasis Respiratory Tract Diseases Thoracic Surgery Ultrasonography

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mahidol University

Bangkok Noi, Bangkok, 10700, Thailand

About this study

The study contains the result from a comparison of diagnostic outcomes about lung collapse by using lung ultrasonography as a new diagnostic test compares to fiberoptic bronchoscopy as a standard test. Both of them detect lung collapse reported as surgical grading lung collapse by the thoracic surgeons. The protocol was performed in a randomized controlled trial whether the subject was allocated to the ultrasonography group or the fiberoptic bronchoscopy group.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients, age ≥18 years old
  • American Society of Anesthesiologists(ASA) physical status classification I - III
  • Scheduled for elective thoracic surgery which requires One lung ventilation(OLV) with Left-sided double lumen tube

Exclusion criteria

  • Anticipated difficult intubation or with the tracheostomy tube
  • Patient with pneumothorax, pleural effusion, emphysema or past history of pleurodesis
  • Patient with deranges pulmonary function test (out of forced expiration volume in 1 s, total lung capacity, forced vital capacity <50% of the predicted values)
  • The patient refuses to participate.

Treatment and study plan

Lung ultrasonography by experienced anaesthesiologist

Diagnostic Test

Use ultrasound image of lung at upper and lower lobe to detect lung collapse and compare grading of lung collapse by surgeon as gold standard

Fiberoptic bronchoscopy for double lumen tube's position

Diagnostic Test

Use fiberoptic bronchoscope via double lumen tube to detect optimum position of double lumen tube and record grading of lung collapse by surgeon as gold standard

Primary outcomes

  1. Number of Patients of Lung Collapse in Ultrasonography and Fiberoptic Bronchoscopy

    Time frame: 30 minutes

    Compare number of patients with lung collapse detected by ultrasonography and fiberoptic bronchoscopy in patient with double lumen tube by report as specificity and sensitivity of detection of lung collapse by compare to visual grading of lung collapse by surgeon

Secondary outcomes

  1. Timing to Detect Lung Collapse

    Time frame: 30 minutes

    Time point from evaluation of lung collapse by each test to time point of grading lung collapse by gold standard( visual grading of lung collapse by surgeon)

  2. Accuracy of Detection of Lung Collapse in Ultrasonography Method in Cardiovascular and Thoracic Anesthesia Fellow

    Time frame: 30 minutes

    Accuracy of detection of lung collapse in thoracic patient with lung ultrasonography in cardiac anaesthesiologist after training lung ultrasonography

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

A Randomized Controlled Study Compare Lung Ultrasonography to Fiberoptic Bronchoscopy Confirming Double Lumen Tube Positioning for Thoracic Surgery.

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 19, 2017
Registry last updated
Mar 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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