Clinical trial NCT03314519: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2017-10-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Compare lung collapse of lung ultrasonography to fiberoptic bronchoscopy.
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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.

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.

Primary outcomes:
measure: Number of Patients of Lung Collapse in Ultrasonography and Fiberoptic Bronchoscopy
timeFrame: 30 minutes
Secondary outcomes:
measure: Timing to Detect Lung Collapse
timeFrame: 30 minutes
measure: Accuracy of Detection of Lung Collapse in Ultrasonography Method in Cardiovascular and Thoracic Anesthesia Fellow
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Bangkok Noi
country: Thailand
facility: Mahidol University
state: Bangkok
Study officials:
affiliation: Siriraj Hospital
name: Kasana Raksamani, MD
role: PRINCIPAL_INVESTIGATOR
References:
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