Endotracheal Tube, Laryngeal Mask Airway, Obese
Conditions
Brief summary
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.
Interventions
A second-generation LMA will be used for airway management (instead of ETT).
Sponsors
M.D. Anderson Cancer Center
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 18-80 years old * Obese (BMI \> or equal to 30 kg/m2 * Scheduled for a non-emergent surgery that requires general anesthesia (e.g., orthopedic, breast, urological, colorectal, ENT, vascular, general surgery) * Willing and able to consent in English or Spanish * No current history of advanced pulmonary or cardiac disease
Exclusion criteria
* Age less than 18 or older than 80 * BMI ≥50 or \< 30 kg/m2 * Patient does not speak English or Spanish * Expected surgical duration longer than 4 hours * Planned postoperative ICU admission * Patient refusal * Monitored anesthesia care (MAC) or regional anesthesia planned * Pregnant or nursing women * Stat (emergent) cases * Known or suspected difficult airway * Full stomach/significant aspiration risk (gastroparesis, emergency surgery, untreated moderate to severe gastroesophageal reflux disease, hiatal hernia) * No history of gastric surgery * Surgery in position other than supine (e.g., Trendelenburg) * Laparoscopic surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants With Postoperative Hypoxia | Up to 80 minutes post-operatively | Patients in the 2 groups will be assessed for postoperative hypoxia (1 or more episodes) in the PACU using a visual analog scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Alterations in Heart Rate | Intra-operatively | Heart rate monitor readings (events) will be recorded throughout the surgery and compared to baseline pre-operative values. |
| Alterations in Oxygen Saturation (at Baseline) | 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. |
| Alterations in Oxygen Saturation (at T15) | at 15 mins postoperatively | Oxygen saturation readings (at T15- after 15 mins in PACU) will be recorded throughout the surgery and compared to baseline pre-operative values. |
| Alterations in Blood Pressure | Intra-operatively | Blood pressure monitor readings (events) will be recorded throughout the surgery and compared to baseline pre-operative values. |
| Alterations in Oxygen Saturation (at T80) | at 80 mins postoperatively | Oxygen saturation readings (at T80- after 80 mins in PACU) will be recorded throughout the surgery and compared to baseline pre-operative values. |
| Alterations in Respiratory Rate | Baseline | Respiratory rate readings (events) will be recorded at baseline. |
| Alterations in Oxygen Saturation (at T45) | at 45 mins postoperatively | Oxygen saturation readings (at T45- after 45 mins in PACU) will be recorded throughout the surgery and compared to baseline pre-operative values. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Endotracheal Tube 7.0/8.0 ETT | 48 |
| Second-Generation LMA Second-Generation Laryngeal Mask Airway: A second-generation LMA will be used for airway management (instead of ETT). | 49 |
| Total | 97 |
Baseline characteristics
| Characteristic | Standard Endotracheal Tube | Second-Generation LMA | Total |
|---|---|---|---|
| Age, Continuous | 45.38 years STANDARD_DEVIATION 13.63 | 47.06 years STANDARD_DEVIATION 14.32 | 46.23 years STANDARD_DEVIATION 13.93 |
| BMI | 34.53 kg/m2 STANDARD_DEVIATION 4.91 | 35.8 kg/m2 STANDARD_DEVIATION 5.11 | 35.17 kg/m2 STANDARD_DEVIATION 5.03 |
| Race/Ethnicity, Customized Black | 5 Participants | 14 Participants | 19 Participants |
| Race/Ethnicity, Customized Hispanic | 36 Participants | 30 Participants | 66 Participants |
| Race/Ethnicity, Customized White | 7 Participants | 5 Participants | 12 Participants |
| Sex: Female, Male Female | 28 Participants | 27 Participants | 55 Participants |
| Sex: Female, Male Male | 20 Participants | 22 Participants | 42 Participants |
| Smoking Status Current Smoker | 4 Participants | 6 Participants | 10 Participants |
| Smoking Status Never | 34 Participants | 34 Participants | 68 Participants |
| Smoking Status Used to but quit | 10 Participants | 9 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 48 | 0 / 49 |
| other Total, other adverse events | 0 / 48 | 0 / 49 |
| serious Total, serious adverse events | 0 / 48 | 0 / 49 |
Outcome results
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.
Time frame: Up to 80 minutes post-operatively
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Endotracheal Tube | Proportion of Participants With Postoperative Hypoxia | 54.2 percentage of participants |
| Second-Generation LMA | Proportion of Participants With Postoperative Hypoxia | 34.7 percentage of participants |
Secondary
Alterations in Blood Pressure
Blood pressure monitor readings (events) will be recorded throughout the surgery and compared to baseline pre-operative values.
Time frame: Intra-operatively
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Endotracheal Tube | Alterations in Blood Pressure | 0 events |
| Second-Generation LMA | Alterations in Blood Pressure | 0 events |
Secondary
Alterations in Heart Rate
Heart rate monitor readings (events) will be recorded throughout the surgery and compared to baseline pre-operative values.
Time frame: Intra-operatively
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Endotracheal Tube | Alterations in Heart Rate | 0 events |
| Second-Generation LMA | Alterations in Heart Rate | 0 events |
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.
Time frame: Baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Endotracheal Tube | Alterations in Oxygen Saturation (at Baseline) | 0 events |
| Second-Generation LMA | Alterations in Oxygen Saturation (at Baseline) | 0 events |
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.
Time frame: at 15 mins postoperatively
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard Endotracheal Tube | Alterations in Oxygen Saturation (at T15) | O2 required (SpO2<95%) | 10 Participants |
| Standard Endotracheal Tube | Alterations in Oxygen Saturation (at T15) | O2 not required | 38 Participants |
| Second-Generation LMA | Alterations in Oxygen Saturation (at T15) | O2 required (SpO2<95%) | 10 Participants |
| Second-Generation LMA | Alterations in Oxygen Saturation (at T15) | O2 not required | 39 Participants |
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.
Time frame: at 45 mins postoperatively
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard Endotracheal Tube | Alterations in Oxygen Saturation (at T45) | O2 required (SpO2<90%) | 3 Participants |
| Standard Endotracheal Tube | Alterations in Oxygen Saturation (at T45) | O2 required (SpO2<95%) | 3 Participants |
| Standard Endotracheal Tube | Alterations in Oxygen Saturation (at T45) | O2 not required | 42 Participants |
| Second-Generation LMA | Alterations in Oxygen Saturation (at T45) | O2 required (SpO2<90%) | 0 Participants |
| Second-Generation LMA | Alterations in Oxygen Saturation (at T45) | O2 required (SpO2<95%) | 3 Participants |
| Second-Generation LMA | Alterations in Oxygen Saturation (at T45) | O2 not required | 46 Participants |
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.
Time frame: at 80 mins postoperatively
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard Endotracheal Tube | Alterations in Oxygen Saturation (at T80) | O2 required (SpO2<90%) | 3 Participants |
| Standard Endotracheal Tube | Alterations in Oxygen Saturation (at T80) | O2 required (SpO2<95%) | 2 Participants |
| Standard Endotracheal Tube | Alterations in Oxygen Saturation (at T80) | O2 not required | 42 Participants |
| Second-Generation LMA | Alterations in Oxygen Saturation (at T80) | O2 not required | 48 Participants |
| Second-Generation LMA | Alterations in Oxygen Saturation (at T80) | O2 required (SpO2<90%) | 0 Participants |
| Second-Generation LMA | Alterations in Oxygen Saturation (at T80) | O2 required (SpO2<95%) | 1 Participants |
Secondary
Alterations in Respiratory Rate
Respiratory rate readings (events) will be recorded at baseline.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Endotracheal Tube | Alterations in Respiratory Rate | 16.33 events | Standard Deviation 2.04 |
| Second-Generation LMA | Alterations in Respiratory Rate | 16.2 events | Standard Deviation 2.16 |