N/A
N=100
Comparison of Laryngeal Mask Airway Supreme and Endotracheal Tube In Patients Undergoing Gynecological Laparoscopy Surgery
Anaesthesia
Bottom Line
View on ClinicalTrials.gov: NCT02127632 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcome: Primary: Mean Airway Pressures — 7; 6; 8; 8 cmH20
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Endotracheal Tube (Device); Laryngeal Mask Airway-Supreme (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Dokuz Eylul University
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Airway Pressures |
7; 6; 8; 8; 8; 8 | — |
| SECONDARY Evaluation of Gastric Distention |
3.24; 2.02 | — |
| SECONDARY Throat Pain According to Visual Analogue Scale |
2.04; 0.32; 0; 0 | — |
Summary
Endotracheal Tube (ETT) is still preferred for laparoscopic surgeries because of the fear of pulmonary aspiration and inadequate ventilation. Laryngeal mask Supreme (LM-S) is a single use device and the presence of a drain tube allows to separate the gastrointestinal and respiratory tracts. We planned to compare ventilation parameters and gastric distension scores of with LM-S vs ETT during laparoscopic gynecological surgery.
Eligibility Criteria
Inclusion Criteria
- ASA classification group I-II
- Between 18-65 years
- Undergoing elective laparoscopic gynecological surgery
Exclusion Criteria
- Individuals with any neck and upper respiratory pathology
- Individuals at risk of gastric content regurgitation/aspiration (previous upper gastrointestinal surgery, known hiatus hernia, gastroesophageal reflux, history of peptic ulcer, full stomach, pregnancy)
- Individuals with low pulmonary compliance or high airway resistance (chronic lung diseases)
- Obese patients (BMI >35)
- Individuals with sore throat, dysphagia and dysphonia
- Individuals with possibility or history of difficult airway
- Operation time planned for more than 4 hours
Data sourced from ClinicalTrials.gov (NCT02127632). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.