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

Primary Purpose

Lung Diseases, Ultrasonography, Fiberoptic Bronchoscopy

Status

Completed

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

Lung ultrasonography by experienced anaesthesiologist

Fiberoptic bronchoscopy for double lumen tube's position

About this trial

This is an interventional diagnostic trial for Lung Diseases focused on measuring Lung ultrasonography, Lung collapse, fiberoptic bronchoscopy, double lumen tube, compare, one lung ventilation, thoracic surgery, thoracic anaesthesia, lung ultrasound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Mahidol University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ultrasonography

Fiberoptic bronchoscopy

Arm Description

Patients in this group receive lung ultrasonography to detect lung collapse after insert double lumen tube and finally compare lung collapse by the surgeon's visual grading scale of lung collapse when entering pleural cavity.

Patients in this group receive fiberoptic bronchoscope to detect lung collapse after inserting a double lumen tube and finally compare lung collapse by the surgeon's visual grading scale of lung collapse when entering the pleural cavity.

Outcomes

Primary Outcome Measures

Number of Patients of Lung Collapse in Ultrasonography and Fiberoptic Bronchoscopy

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 Outcome Measures

Timing to Detect Lung Collapse

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)

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

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

Full Information

NCT ID

NCT03314519

First Posted

October 15, 2017

Last Updated

March 10, 2020

Sponsor

Mahidol University

1. Study Identification

Unique Protocol Identification Number

NCT03314519

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

October 20, 2017 (Actual)

Primary Completion Date

July 10, 2019 (Actual)

Study Completion Date

July 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mahidol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lung Diseases, Ultrasonography, Fiberoptic Bronchoscopy, One Lung Ventilation, Thoracic Surgery, Lung Collapse

Keywords

Lung ultrasonography, Lung collapse, fiberoptic bronchoscopy, double lumen tube, compare, one lung ventilation, thoracic surgery, thoracic anaesthesia, lung ultrasound

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Compare lung collapse of lung ultrasonography to fiberoptic bronchoscopy.

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ultrasonography

Arm Type

Experimental

Arm Description

Arm Title

Fiberoptic bronchoscopy

Arm Type

Active Comparator

Arm Description

Intervention Type

Diagnostic Test

Intervention Name(s)

Lung ultrasonography by experienced anaesthesiologist

Intervention Description

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

Intervention Type

Diagnostic Test

Intervention Name(s)

Fiberoptic bronchoscopy for double lumen tube's position

Intervention Description

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 Outcome Measure Information:

Title

Number of Patients of Lung Collapse in Ultrasonography and Fiberoptic Bronchoscopy

Description

Time Frame

30 minutes

Secondary Outcome Measure Information:

Title

Timing to Detect Lung Collapse

Description

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)

Time Frame

30 minutes

Title

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

Description

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

Time Frame

30 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kasana Raksamani, MD

Organizational Affiliation

Siriraj Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mahidol University

City

Bangkok Noi

State/Province

Bangkok

ZIP/Postal Code

10700

Country

Thailand

12. IPD Sharing Statement

Plan to Share IPD

Citations:

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Citation

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

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