Obesity
Conditions
Keywords
Obesity, One-Lung Ventilation, Anesthesia, Thoracic, One-lung ventilation in the morbidly obese patient
Brief summary
The purpose of this study is to determine whether the double-lumen endotracheal tube or the standard single-lumen tracheal tube, with an Arndt® blocker, is superior in providing one lung ventilation during thoracic surgery.
Detailed description
The purpose of the study is to compare a double lumen tube versus the standard single-lumen tracheal tube, with an Arndt® blocker, in the morbidly obese patient who requires one-lung ventilation during surgery. The objects is to determine which device is best for intubation and is most effective in terms of optimal positioning of the device, of lung collapse, and quality of lung isolation.
Interventions
DEVICEArndt Bronchial Blocker
Sponsors
Javier H Campos
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
prospective randomized study
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Subject undergoing thoracic or esophageal surgery requiring one-lung ventilation. 2. Subject is \>18 years of age. 3. Subject's BMI \> 35.
Exclusion criteria
1. Subject \< 18 years of age. 2. Subject's BMI \< 35.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time Taken for Endotracheal Tube Placement Procedure. | 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. |
| Number of Participants in Which the Tube Was Successfully Positioned at First Attempt | This data measure was occurred during surgery. | Number of participants in each group in which the tube was successfully positioned at first attempt |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of Lung Collapse | 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. |
| Time Required to Collapse the Lung | 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. |
| Number of Participants With Successful Reinflation | This occurred during surgery. | In each group, the number of Participants in which successful lung reinflation occurred. |
| Mean Intraoperative Oxygenation During One-lung Ventilation | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Double Lumen Endotracheal Tube 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 | 25 |
| Arndt Bronchial Blocker 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 | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | Arndt Bronchial Blocker | Double Lumen Endotracheal Tube | Total |
|---|---|---|---|
| Age, Continuous | 53 years | 52 years | 52 years |
| Body Mass Index | 40.2 kg/m^2 STANDARD_DEVIATION 4.5 | 39.9 kg/m^2 STANDARD_DEVIATION 4.8 | 40 kg/m^2 STANDARD_DEVIATION 4.5 |
| Body Weight | 116.5 Kilograms STANDARD_DEVIATION 22.4 | 114.5 Kilograms STANDARD_DEVIATION 17.1 | 115.6 Kilograms STANDARD_DEVIATION 19.9 |
| double lumen tubes versus bronchial blockers | 25 Participants | 25 Participants | 50 Participants |
| Neck Circumference | 47 Centimeters STANDARD_DEVIATION 7 | 46 Centimeters STANDARD_DEVIATION 4 | 46.3 Centimeters STANDARD_DEVIATION 5.9 |
| Sex: Female, Male Female | 13 Participants | 14 Participants | 27 Participants |
| Sex: Female, Male Male | 12 Participants | 11 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 3 / 25 | 2 / 25 |
Outcome results
Primary
Number of Participants in Which the Tube Was Successfully Positioned at First Attempt
Number of participants in each group in which the tube was successfully positioned at first attempt
Time frame: This data measure was occurred during surgery.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Double Lumen Endotracheal Tube | Number of Participants in Which the Tube Was Successfully Positioned at First Attempt | 22 Participants |
| Arndt Bronchial Blocker | Number of Participants in Which the Tube Was Successfully Positioned at First Attempt | 23 Participants |
Primary
Time Taken for Endotracheal Tube Placement 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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Double Lumen Endotracheal Tube | Time Taken for Endotracheal Tube Placement Procedure. | 3.4 minutes | Standard Deviation 1.8 |
| Arndt Bronchial Blocker | Time Taken for Endotracheal Tube Placement Procedure. | 4.1 minutes | Standard Deviation 5.2 |
Secondary
Effectiveness of Lung Collapse
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.
Time frame: This measure occured during surgery just after intubation.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Double Lumen Endotracheal Tube | Effectiveness of Lung Collapse | Good | 16 Participants |
| Double Lumen Endotracheal Tube | Effectiveness of Lung Collapse | Fair | 7 Participants |
| Double Lumen Endotracheal Tube | Effectiveness of Lung Collapse | Poor | 1 Participants |
| Double Lumen Endotracheal Tube | Effectiveness of Lung Collapse | Lung Colapse not Required | 1 Participants |
| Arndt Bronchial Blocker | Effectiveness of Lung Collapse | Lung Colapse not Required | 0 Participants |
| Arndt Bronchial Blocker | Effectiveness of Lung Collapse | Good | 17 Participants |
| Arndt Bronchial Blocker | Effectiveness of Lung Collapse | Poor | 1 Participants |
| Arndt Bronchial Blocker | Effectiveness of Lung Collapse | Fair | 7 Participants |
Secondary
Mean Intraoperative Oxygenation During One-lung Ventilation
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.
Time frame: This measure occured during surgery.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Double Lumen Endotracheal Tube | Mean Intraoperative Oxygenation During One-lung Ventilation | 16.8 kPa | Standard Deviation 8.8 |
| Arndt Bronchial Blocker | Mean Intraoperative Oxygenation During One-lung Ventilation | 18.6 kPa | Standard Deviation 10.3 |
Secondary
Number of Participants With Successful Reinflation
In each group, the number of Participants in which successful lung reinflation occurred.
Time frame: This occurred during surgery.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Double Lumen Endotracheal Tube | Number of Participants With Successful Reinflation | 24 Participants |
| Arndt Bronchial Blocker | Number of Participants With Successful Reinflation | 25 Participants |
Secondary
Time Required to Collapse the Lung
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.
Time frame: This measurement occurred during surgery.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Double Lumen Endotracheal Tube | Time Required to Collapse the Lung | 18 Minutes | Standard Deviation 9.3 |
| Arndt Bronchial Blocker | Time Required to Collapse the Lung | 15.8 Minutes | Standard Deviation 9.6 |