Trial Outcomes & Findings for One-Lung Ventilation in the Morbidly Obese Patient: Comparison of Double Lumen Versus Bronchial Blockers (NCT NCT00813176)

Results Overview

For each group, the time in minutes required for the anesthesiologist to successfully place the endotracheal tube. Intubation time was recorded as the time from when the tracheal tube passed the vocal cords until the anesthetist concluded that the DLT (Arm 1) or the single-lumen tube with the Arndt blocker (Arm 2) was correctly placed and optimal position was confirmed with the fiberoptic bronchoscope.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

This measurement occurred after the patient was in the operating room and the randomization group was determined. This measurement began and ended during the intubation procedure.

Results posted on

2018-06-04

Participant Flow

Participant milestones

Participant milestones
Measure	Double Lumen Endotracheal Tube Double Lumen Endotracheal Tube This group was one arm of this research to determine the advantages of this group versus a comparative bronchial blocker group. We assessed 56 subjects and enrolled 50. A total of 6 were excluded because they did not meet criteria (4) or refused to participate (2).	Arndt Bronchial Blocker Arndt Bronchial Blocker We assessed 56 subjects and enrolled 50. A total of 6 were excluded because they did not meet criteria (4) or refused to participate (2).
Overall Study STARTED	25	25
Overall Study COMPLETED	25	25
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

One-Lung Ventilation in the Morbidly Obese Patient: Comparison of Double Lumen Versus Bronchial Blockers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Double Lumen Endotracheal Tube n=25 Participants Double Lumen Endotracheal Tube Device where lung collapse can be achieved by clamping one of the lumens (the operated lung) 25 subjects were enrolled in this group	Arndt Bronchial Blocker n=25 Participants Arndt Bronchial Blocker in conjunction with a single lumen endotracheal tube. Device that allows collapse of one lung (the operated lung). 25 subjects were enrolled in this group	Total n=50 Participants Total of all reporting groups
Age, Continuous	52 years n=5 Participants	53 years n=7 Participants	52 years n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
double lumen tubes versus bronchial blockers	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Body Mass Index	39.9 kg/m^2 STANDARD_DEVIATION 4.8 • n=5 Participants	40.2 kg/m^2 STANDARD_DEVIATION 4.5 • n=7 Participants	40 kg/m^2 STANDARD_DEVIATION 4.5 • n=5 Participants
Body Weight	114.5 Kilograms STANDARD_DEVIATION 17.1 • n=5 Participants	116.5 Kilograms STANDARD_DEVIATION 22.4 • n=7 Participants	115.6 Kilograms STANDARD_DEVIATION 19.9 • n=5 Participants
Neck Circumference	46 Centimeters STANDARD_DEVIATION 4 • n=5 Participants	47 Centimeters STANDARD_DEVIATION 7 • n=7 Participants	46.3 Centimeters STANDARD_DEVIATION 5.9 • n=5 Participants

PRIMARY outcome

Timeframe: This measurement occurred after the patient was in the operating room and the randomization group was determined. This measurement began and ended during the intubation procedure.

For each group, the time in minutes required for the anesthesiologist to successfully place the endotracheal tube. Intubation time was recorded as the time from when the tracheal tube passed the vocal cords until the anesthetist concluded that the DLT (Arm 1) or the single-lumen tube with the Arndt blocker (Arm 2) was correctly placed and optimal position was confirmed with the fiberoptic bronchoscope.

Outcome measures

Outcome measures
Measure	Arndt Bronchial Blocker n=25 Participants Arndt Bronchial Blocker	Double Lumen Endotracheal Tube n=25 Participants Left-sided double lumen endotracheal tube Broncho-Cath®
Time Taken for Endotracheal Tube Placement Procedure.	4.1 minutes Standard Deviation 5.2	3.4 minutes Standard Deviation 1.8

PRIMARY outcome

Timeframe: This data measure was occurred during surgery.

Number of participants in each group in which the tube was successfully positioned at first attempt

Outcome measures

Outcome measures
Measure	Arndt Bronchial Blocker n=25 Participants Arndt Bronchial Blocker	Double Lumen Endotracheal Tube n=25 Participants Left-sided double lumen endotracheal tube Broncho-Cath®
Number of Participants in Which the Tube Was Successfully Positioned at First Attempt	23 Participants	22 Participants

SECONDARY outcome

Timeframe: This measure occured during surgery just after intubation.

For each group, the number of participants in which lung collapse was evaluated as: (i) good-complete collapse without surgical interference, (ii) fair-total collapse, but with residual air, and (iii) poor-no or partial collapse, lung inflated and interfering with the surgical exposure.

Outcome measures

Outcome measures
Measure	Arndt Bronchial Blocker n=25 Participants Arndt Bronchial Blocker	Double Lumen Endotracheal Tube n=25 Participants Left-sided double lumen endotracheal tube Broncho-Cath®
Effectiveness of Lung Collapse Good	17 Participants	16 Participants
Effectiveness of Lung Collapse Fair	7 Participants	7 Participants
Effectiveness of Lung Collapse Poor	1 Participants	1 Participants
Effectiveness of Lung Collapse Lung Colapse not Required	0 Participants	1 Participants

SECONDARY outcome

Timeframe: This measurement occurred during surgery.

For each group, the mean time for lung isolation/collapse was measured from the institution of one-lung ventilation to the time of total lung collapse.

Outcome measures

Outcome measures
Measure	Arndt Bronchial Blocker n=25 Participants Arndt Bronchial Blocker	Double Lumen Endotracheal Tube n=25 Participants Left-sided double lumen endotracheal tube Broncho-Cath®
Time Required to Collapse the Lung	15.8 Minutes Standard Deviation 9.6	18 Minutes Standard Deviation 9.3

SECONDARY outcome

Timeframe: This occurred during surgery.

In each group, the number of Participants in which successful lung reinflation occurred.

Outcome measures

Outcome measures
Measure	Arndt Bronchial Blocker n=25 Participants Arndt Bronchial Blocker	Double Lumen Endotracheal Tube n=25 Participants Left-sided double lumen endotracheal tube Broncho-Cath®
Number of Participants With Successful Reinflation	25 Participants	24 Participants

SECONDARY outcome

Timeframe: This measure occured during surgery.

For each group, the mean intraoperative oxygenation (arterial partial pressure of oxygen measured by arterial blood gases) were taken during two-lung ventilation (baseline) and after 30 min of one-lung ventilation.

Outcome measures

Outcome measures
Measure	Arndt Bronchial Blocker n=25 Participants Arndt Bronchial Blocker	Double Lumen Endotracheal Tube n=25 Participants Left-sided double lumen endotracheal tube Broncho-Cath®
Mean Intraoperative Oxygenation During One-lung Ventilation	18.6 kPa Standard Deviation 10.3	16.8 kPa Standard Deviation 8.8

Adverse Events

Double Lumen Endotracheal Tube

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Arndt Bronchial Blocker

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Double Lumen Endotracheal Tube n=25 participants at risk Left-sided double lumen endotracheal tube Broncho-Cath®	Arndt Bronchial Blocker n=25 participants at risk Arndt® blocker group: Intubation with a standard single-lumen tracheal tube (8.0-9.0 mm ID) followed by the passage of a 9 Fr Arndt® spherical blocker.
Respiratory, thoracic and mediastinal disorders failure to intubate at first attempt	12.0% 3/25 • Number of events 3	8.0% 2/25 • Number of events 2
Respiratory, thoracic and mediastinal disorders	4.0% 1/25 • Number of events 1	4.0% 1/25 • Number of events 1
Respiratory, thoracic and mediastinal disorders low PaO2 was seen in two patients one in each group and required Continuous positive airway pressure	4.0% 1/25 • Number of events 1	4.0% 1/25 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Dr Javier H Campos

University of Iowa

Phone: 3193567208

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place