Trial Outcomes & Findings for Lung Ultrasonography vs Fiberoptic Bronchoscopy for Aiding Lung Collapse in Patient Using Double Lumen Tube (NCT NCT03314519)

NCT ID: NCT03314519

Last Updated: 2020-03-12

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 200 participants
• Primary outcome timeframe: 30 minutes
• Results posted on: 2020-03-12

Participant Flow

Participant milestones

Measure	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	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
Overall Study STARTED	100	100
Overall Study COMPLETED	97	98
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Measure	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	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
Overall Study Protocol Violation	3	2

Baseline Characteristics

There are protocol deviations of 3 patients in Group US and 2 patients in group FOB.

Baseline characteristics by cohort

Measure	Ultrasonography n=97 Participants 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	Fiberoptic Bronchoscopy n=98 Participants 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	Total n=195 Participants Total of all reporting groups
Age, Continuous	60.4 years STANDARD_DEVIATION 15.6 • n=97 Participants • There are protocol deviations of 3 patients in Group US and 2 patients in group FOB.	60.6 years STANDARD_DEVIATION 12.8 • n=98 Participants • There are protocol deviations of 3 patients in Group US and 2 patients in group FOB.	60.5 years STANDARD_DEVIATION 14.3 • n=195 Participants • There are protocol deviations of 3 patients in Group US and 2 patients in group FOB.
Sex: Female, Male Female	59 Participants n=97 Participants • There are protocol deviations of 3 patients in Group US and 2 patients in group FOB.	50 Participants n=98 Participants • There are protocol deviations of 3 patients in Group US and 2 patients in group FOB.	109 Participants n=195 Participants • There are protocol deviations of 3 patients in Group US and 2 patients in group FOB.
Sex: Female, Male Male	38 Participants n=97 Participants • There are protocol deviations of 3 patients in Group US and 2 patients in group FOB.	48 Participants n=98 Participants • There are protocol deviations of 3 patients in Group US and 2 patients in group FOB.	86 Participants n=195 Participants • There are protocol deviations of 3 patients in Group US and 2 patients in group FOB.
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Thailand	97 participants n=97 Participants	98 participants n=98 Participants	195 participants n=195 Participants
BMI	24.4 kg/m^2 STANDARD_DEVIATION 4.4 • n=97 Participants	24.0 kg/m^2 STANDARD_DEVIATION 4.3 • n=98 Participants	24.2 kg/m^2 STANDARD_DEVIATION 4.3 • n=195 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Ultrasonography n=97 Participants 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	Fiberoptic Bronchoscopy n=98 Participants 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
Number of Patients of Lung Collapse in Ultrasonography and Fiberoptic Bronchoscopy	89 Participants	83 Participants

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Ultrasonography n=97 Participants 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	Fiberoptic Bronchoscopy n=98 Participants 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
Timing to Detect Lung Collapse	14 minutes Interval 9.5 to 20.0	9 minutes Interval 5.0 to 14.3

SECONDARY outcome

Timeframe: 30 minutes

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

Outcome measures

Measure	Ultrasonography n=97 Participants 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	Fiberoptic Bronchoscopy n=98 Participants 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
Accuracy of Detection of Lung Collapse in Ultrasonography Method in Cardiovascular and Thoracic Anesthesia Fellow	89 Participants	83 Participants

Adverse Events

Ultrasonography

Serious events: 0 serious events

Other events: 33 other events

Deaths: 0 deaths

Fiberoptic Bronchoscopy

Serious events: 0 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Ultrasonography n=97 participants at risk 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	Fiberoptic Bronchoscopy n=98 participants at risk 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
Cardiac disorders Hypotension	34.0% 33/97 • Number of events 33 • Total intraoperative period, an average of 1 hour Desaturation	29.6% 29/98 • Number of events 29 • Total intraoperative period, an average of 1 hour Desaturation
Cardiac disorders Desaturation	16.5% 16/97 • Number of events 16 • Total intraoperative period, an average of 1 hour Desaturation	11.2% 11/98 • Number of events 11 • Total intraoperative period, an average of 1 hour Desaturation

Additional Information

Kasana Raksamanee

Mahidol University

Phone: 66967841010

Email: kasana@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place