Fiberoptic Bronchoscopy, Lung Collapse, Lung Diseases, One Lung Ventilation, Thoracic Surgery, Ultrasonography
Conditions
Keywords
Lung ultrasonography, Lung collapse, fiberoptic bronchoscopy, double lumen tube, compare, one lung ventilation, thoracic surgery, thoracic anaesthesia, lung ultrasound
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.
Interventions
DIAGNOSTIC_TESTLung ultrasonography by experienced anaesthesiologist
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
DIAGNOSTIC_TESTFiberoptic bronchoscopy for double lumen tube's position
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
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
Compare lung collapse of lung ultrasonography to fiberoptic bronchoscopy.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients of Lung Collapse in Ultrasonography and Fiberoptic Bronchoscopy | 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
| Measure | Time frame | Description |
|---|---|---|
| Timing to Detect Lung Collapse | 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) |
| Accuracy of Detection of Lung Collapse in Ultrasonography Method in Cardiovascular and Thoracic Anesthesia Fellow | 30 minutes | Accuracy of detection of lung collapse in thoracic patient with lung ultrasonography in cardiac anaesthesiologist after training lung ultrasonography |
Countries
Thailand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ultrasonography 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.
Lung ultrasonography by experienced anaesthesiologist: 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 | 97 |
| Fiberoptic Bronchoscopy 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.
Fiberoptic bronchoscopy for double lumen tube's position: 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 | 98 |
| Total | 195 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 3 | 2 |
Baseline characteristics
| Characteristic | Ultrasonography | Fiberoptic Bronchoscopy | Total |
|---|---|---|---|
| Age, Continuous | 60.4 years STANDARD_DEVIATION 15.6 | 60.6 years STANDARD_DEVIATION 12.8 | 60.5 years STANDARD_DEVIATION 14.3 |
| BMI | 24.4 kg/m^2 STANDARD_DEVIATION 4.4 | 24.0 kg/m^2 STANDARD_DEVIATION 4.3 | 24.2 kg/m^2 STANDARD_DEVIATION 4.3 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Thailand | 97 participants | 98 participants | 195 participants |
| Sex: Female, Male Female | 59 Participants | 50 Participants | 109 Participants |
| Sex: Female, Male Male | 38 Participants | 48 Participants | 86 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 97 | 0 / 98 |
| other Total, other adverse events | 33 / 97 | 29 / 98 |
| serious Total, serious adverse events | 0 / 97 | 0 / 98 |
Outcome results
Primary
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
Time frame: 30 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ultrasonography | Number of Patients of Lung Collapse in Ultrasonography and Fiberoptic Bronchoscopy | 89 Participants |
| Fiberoptic Bronchoscopy | Number of Patients of Lung Collapse in Ultrasonography and Fiberoptic Bronchoscopy | 83 Participants |
Secondary
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
Time frame: 30 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ultrasonography | Accuracy of Detection of Lung Collapse in Ultrasonography Method in Cardiovascular and Thoracic Anesthesia Fellow | 89 Participants |
| Fiberoptic Bronchoscopy | Accuracy of Detection of Lung Collapse in Ultrasonography Method in Cardiovascular and Thoracic Anesthesia Fellow | 83 Participants |
Secondary
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)
Time frame: 30 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ultrasonography | Timing to Detect Lung Collapse | 14 minutes |
| Fiberoptic Bronchoscopy | Timing to Detect Lung Collapse | 9 minutes |