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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Double Lumen Endotracheal Tube | Active Comparator | We used a device called a double lumen tube ( DLT Broncho-Cath®). It is a bifurcated endotracheal tube designed to independently collapse the operated lung. |
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| Arndt Bronchial Blocker | Active Comparator | We used a device called a bronchial blocker (9 Fr Arndt® blocker) along with a standard single-lumen tracheal tube (8.0-9.0 mm ID). The Arndt bronchial blocker is a single device, with a distal balloon that is passed thru the single lumen endotracheal once the patient is intubated. The Arndt bronchial blocker is designed to collapse the operated lung. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Double Lumen Endotracheal Tube | Device |
| ||
| Arndt Bronchial Blocker |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| 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 | This data measure was occurred during surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | This measure occured during surgery just after intubation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Javier H Campos, MD | Iowa Health Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa | Iowa City | Iowa | 52241 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Arndt Bronchial Blocker |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | minutes | 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. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Double Lumen Endotracheal Tube | Left-sided double lumen endotracheal tube Broncho-Cath® |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| failure to intubate at first attempt | Respiratory, thoracic and mediastinal disorders | failure to intubate | Systematic Assessment | failure to intubate at first attempt |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Javier H Campos | University of Iowa | 3193567208 | javier-campos@uiowa.edu |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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prospective randomized study
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| Device |
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| 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. | This measurement occurred during surgery. |
| Number of Participants With Successful Reinflation | In each group, the number of Participants in which successful lung reinflation occurred. | This occurred during surgery. |
| 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. | This measure occured during surgery. |
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
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| double lumen tubes versus bronchial blockers | Count of Participants | Participants |
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| Body Mass Index | Body Mass Index of obesity or being underweight. It is body weight divided by body height squared (BMI=kg/m^2) | Mean | Standard Deviation | kg/m^2 |
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| Body Weight | Mean | Standard Deviation | Kilograms |
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| Neck Circumference | Mean | Standard Deviation | Centimeters |
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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 |
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| 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 | Posted | Count of Participants | Participants | This data measure was occurred during surgery. |
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| 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. | Posted | Count of Participants | Participants | This measure occured during surgery just after intubation. |
|
|
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| 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. | Posted | Mean | Standard Deviation | Minutes | This measurement occurred during surgery. |
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| Secondary | Number of Participants With Successful Reinflation | In each group, the number of Participants in which successful lung reinflation occurred. | Posted | Count of Participants | Participants | This occurred during surgery. |
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|
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| 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. | Posted | Mean | Standard Deviation | kPa | This measure occured during surgery. |
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|
| 3 |
| 25 |
| 0 |
| 25 |
| EG001 | Arndt Bronchial Blocker | 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. | 2 | 25 | 0 | 25 |
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| Respiratory, thoracic and mediastinal disorders | there were no complications or adverse events related to this study |
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| low PaO2 was seen in two patients one in each group and required Continuous positive airway pressure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | low Pao2 that was seen in one patient in each group and it was corrected with continuous positive airway pressure ventilation |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Poor |
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| Lung Colapse not Required |
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