Second-Generation LMA for Obesity

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Obesity+2 MoreSecond-Generation Laryngeal Mask Airway - Device
Eligibility
18 - 80
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare the efficacy of a second-generation LMA to endotracheal intubation in 148 patients with a BMI of 30-49.9 kg/m2.

Eligible Conditions
  • Obesity
  • Laryngeal Mask Airway
  • Endotracheal Tube

Treatment Effectiveness

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Intra-operatively

Intra-operatively
Alterations in blood pressure
Alterations in heart rate
Alterations in oxygen saturation
Alterations in respiratory rate
Up to 80 minutes post-operatively
Postoperative hypoxia

Trial Safety

Trial Design

2 Treatment Groups

Second-Generation LMA
1 of 2
Standard Endotracheal Tube
1 of 2

Active Control

300 Total Participants · 2 Treatment Groups

Primary Treatment: Second-Generation LMA · No Placebo Group · N/A

Second-Generation LMA
Device
ActiveComparator Group · 1 Intervention: Second-Generation Laryngeal Mask Airway · Intervention Types: Device
Standard Endotracheal TubeNoIntervention Group · 1 Intervention: Standard Endotracheal Tube · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: intra-operatively

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
951 Previous Clinical Trials
607,520 Total Patients Enrolled
20 Trials studying Obesity
4,921 Patients Enrolled for Obesity
M.D. Anderson Cancer CenterOTHER
2,802 Previous Clinical Trials
1,788,603 Total Patients Enrolled
9 Trials studying Obesity
2,650 Patients Enrolled for Obesity
Tiffany S Moon, M.D.Principal InvestigatorUniversity of Texas

Eligibility Criteria

Age 18 - 80 · All Participants · 5 Total Inclusion Criteria

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Who else is applying?

What state do they live in?
Texas100.0%
What site did they apply to?
MD Anderson Cancer Center100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
Why did patients apply to this trial?
  • "I have tired so many things over the counter and working out, walking to lose weight and its on a stand still for years. I hate being fat"
How many prior treatments have patients received?
3+100.0%