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| Name | Class |
|---|---|
| M.D. Anderson Cancer Center | OTHER |
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This prospective, randomized, comparative study is intended to enroll a total of 148 patients with a BMI 30-49.9 kg/m2 undergoing surgery at Parkland Hospital. The efficacy and performance of a second-generation LMA will be compared to endotracheal intubation. A standardized anesthetic protocol that is usual and customary for the type of operation the patient is having will be provided to the anesthesia teams of enrolled subjects. The remainder of the anesthetic care of the subject will not deviate from the standard of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Endotracheal Tube | No Intervention | ||
| Second-Generation LMA | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Second-Generation Laryngeal Mask Airway | Device | A second-generation LMA will be used for airway management (instead of ETT). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With Postoperative Hypoxia | Patients in the 2 groups will be assessed for postoperative hypoxia (1 or more episodes) in the PACU using a visual analog scale. | Up to 80 minutes post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Alterations in Blood Pressure | Blood pressure monitor readings (events) will be recorded throughout the surgery and compared to baseline pre-operative values. | Intra-operatively |
| Alterations in Heart Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tiffany S Moon, M.D. | University of Texas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parkland Health & Hospital System | Dallas | Texas | 75211 | United States | ||
| MD Anderson Cancer Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Endotracheal Tube | Normal endotracheal tube |
| FG001 | Second-Generation LMA | Second-Generation Laryngeal Mask Airway: A second-generation LMA will be used for airway management (instead of ETT). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Endotracheal Tube | 7.0/8.0 ETT |
| BG001 | Second-Generation LMA | Second-Generation Laryngeal Mask Airway: A second-generation LMA will be used for airway management (instead of ETT). |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Proportion of Participants With Postoperative Hypoxia | Patients in the 2 groups will be assessed for postoperative hypoxia (1 or more episodes) in the PACU using a visual analog scale. | Posted | Number | percentage of participants | Up to 80 minutes post-operatively |
|
until 1 hour after PACU arrival
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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 | Standard Endotracheal Tube | Direct laryngoscopy performed and endotracheal tubeinserted. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tiffany Moon | UT Southwestern Medical Center | 469/419-5790 | Tiffany.Moon@UTSouthwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 28, 2021 | Mar 28, 2025 | Prot_SAP_000.pdf |
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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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Heart rate monitor readings (events) will be recorded throughout the surgery and compared to baseline pre-operative values.
| Intra-operatively |
| Alterations in Oxygen Saturation (at Baseline) | Oxygen saturation readings (events) will be recorded throughout the surgery and compared to baseline pre-operative values. Number of participants that did not require O2 is reported in the data table below. | Baseline |
| Alterations in Oxygen Saturation (at T15) | Oxygen saturation readings (at T15- after 15 mins in PACU) will be recorded throughout the surgery and compared to baseline pre-operative values. | at 15 mins postoperatively |
| Alterations in Oxygen Saturation (at T45) | Oxygen saturation readings (at T45- after 45 mins in PACU) will be recorded throughout the surgery and compared to baseline pre-operative values. | at 45 mins postoperatively |
| Alterations in Oxygen Saturation (at T80) | Oxygen saturation readings (at T80- after 80 mins in PACU) will be recorded throughout the surgery and compared to baseline pre-operative values. | at 80 mins postoperatively |
| Alterations in Respiratory Rate | Respiratory rate readings (events) will be recorded at baseline. | Baseline |
| Houston |
| Texas |
| 77030 |
| United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m2 |
|
| Smoking Status | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Alterations in Blood Pressure | Blood pressure monitor readings (events) will be recorded throughout the surgery and compared to baseline pre-operative values. | Posted | Number | events | Intra-operatively |
|
|
|
| Secondary | Alterations in Heart Rate | Heart rate monitor readings (events) will be recorded throughout the surgery and compared to baseline pre-operative values. | Posted | Number | events | Intra-operatively |
|
|
|
| Secondary | Alterations in Oxygen Saturation (at Baseline) | Oxygen saturation readings (events) will be recorded throughout the surgery and compared to baseline pre-operative values. Number of participants that did not require O2 is reported in the data table below. | Posted | Number | events | Baseline |
|
|
|
| Secondary | Alterations in Oxygen Saturation (at T15) | Oxygen saturation readings (at T15- after 15 mins in PACU) will be recorded throughout the surgery and compared to baseline pre-operative values. | Posted | Count of Participants | Participants | at 15 mins postoperatively |
|
|
|
| Secondary | Alterations in Oxygen Saturation (at T45) | Oxygen saturation readings (at T45- after 45 mins in PACU) will be recorded throughout the surgery and compared to baseline pre-operative values. | Posted | Count of Participants | Participants | at 45 mins postoperatively |
|
|
|
| Secondary | Alterations in Oxygen Saturation (at T80) | Oxygen saturation readings (at T80- after 80 mins in PACU) will be recorded throughout the surgery and compared to baseline pre-operative values. | Posted | Count of Participants | Participants | at 80 mins postoperatively |
|
|
|
| Secondary | Alterations in Respiratory Rate | Respiratory rate readings (events) will be recorded at baseline. | Posted | Mean | Standard Deviation | events | Baseline |
|
|
|
| 0 |
| 48 |
| 0 |
| 48 |
| 0 |
| 48 |
| EG001 | Second-Generation LMA | Second-Generation Laryngeal Mask Airway: A second-generation LMA will be used for airway management (instead of ETT). | 0 | 49 | 0 | 49 | 0 | 49 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| O2 not required |
|
| O2 not required |
|