ObeseNCT03748342
Second Generation LMA Versus Endotracheal Tube in Obese Patients
A study testing Second-Generation Laryngeal Mask Airway in people with Obese and Endotracheal Tube, run by University of Texas Southwestern Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obese, Endotracheal Tube, Laryngeal Mask Airway
- What is being tested?
- Second-Generation Laryngeal Mask Airway
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Jun 2019to 3 Feb 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Parkland Health & Hospital System
Dallas, Texas, 75211
MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: The Use of a Second-Generation Laryngeal Mask Airway Versus Endotracheal Tube in Obese Patients
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.
- Conditions
- Obese, Endotracheal Tube, Laryngeal Mask Airway
- Being tested
- Second-Generation Laryngeal Mask Airway
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Second-Generation Laryngeal Mask AirwayDevice
A second-generation LMA will be used for airway management (instead of ETT).
| Study group | Role | What they receive |
|---|---|---|
| Standard Endotracheal Tube | No intervention | Not described |
| Second-Generation LMA | Active comparator | Not described Receives: Device: Second-Generation Laryngeal Mask Airway |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 80 minutes post-operatively
Secondary outcomes (7)
Alterations in Blood Pressure
Blood pressure monitor readings (events) will be recorded throughout the surgery and compared to baseline pre-operative values.
Measured: Intra-operatively
Alterations in Heart Rate
Heart rate monitor readings (events) will be recorded throughout the surgery and compared to baseline pre-operative values.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at 80 mins postoperatively
Alterations in Respiratory Rate
Respiratory rate readings (events) will be recorded at baseline.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start27 Jun 2019
- Primary completion2 Feb 2024
- Study completion3 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObeseStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- M.D. Anderson Cancer Center
- Responsible party
- Principal investigator, Tiffany B Moon, University of Texas Southwestern Medical Center
- Investigators
- Tiffany S Moon, M.D., Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03748342
- Sponsor's protocol ID
- STU-112017-050
- Status last verified
- Mar 2025
- First submitted
- 22 Oct 2018
- Last updated
- 17 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of a Second-Generation Laryngeal Mask Airway Versus Endotracheal Tube in Obese Patients
- ClinicalTrials.gov ID
- NCT03748342
- Acronym / sponsor ID
- STU-112017-050
- Conditions
- Obese, Endotracheal Tube, Laryngeal Mask Airway
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- M.D. Anderson Cancer Center
- Study start
- 27 Jun 2019 (actual)
- Primary completion
- 2 Feb 2024 (actual)
- Study completion
- 3 Feb 2025 (actual)
- First posted
- 20 Nov 2018 (actual)
- Results
- Posted 17 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Endotracheal Tube | No intervention | – |
| Second-Generation LMA | Active comparator | Device: Second-Generation Laryngeal Mask Airway |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Second-Generation Laryngeal Mask AirwayA second-generation LMA will be used for airway management (instead of ETT). | Device | Second-Generation LMA |
Primary outcome
Proportion of Participants With Postoperative Hypoxia
Time frame: 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.
7 secondary outcomes
Alterations in Blood Pressure
Time frame: Intra-operatively
Alterations in Heart Rate
Time frame: Intra-operatively
Alterations in Oxygen Saturation (at Baseline)
Time frame: Baseline
Alterations in Oxygen Saturation (at T15)
Time frame: at 15 mins postoperatively
Alterations in Oxygen Saturation (at T45)
Time frame: at 45 mins postoperatively
Alterations in Oxygen Saturation (at T80)
Time frame: at 80 mins postoperatively
Alterations in Respiratory Rate
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tiffany S Moon, M.D. principal investigator
University of Texas
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Second-Generation Laryngeal Mask Airway in people with Obese and Endotracheal Tube, run by University of Texas Southwestern Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants With Postoperative Hypoxia (time frame: Up to 80 minutes post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.