N/A
N=50
Comparison of I-gel to the Laryngeal Mask Airway
Endotracheal Intubation · Supraglottic Airway
Bottom Line
View on ClinicalTrials.gov: NCT00706823 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Apr 2011
Primary outcome: Primary: Time Required for Intubation — 21.04; 30.04 seconds — p=0.02
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- i-gel airway (Intersurgical Ltd., Wokingham, England) (Device); Laryngeal Mask Airway-Unique (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time Required for Intubation |
21.04; 30.04 | 0.02 sig |
| PRIMARY Leak Pressure |
23.08; 20.88 | 0.22 |
| SECONDARY Level of Difficulty for Intubation |
11; 8; 12; 17; 0; 0 | 0.22 |
| SECONDARY Number of Participants With Oropharyngeal Discomfort |
6; 10; 19; 15 | — |
| SECONDARY Number of Participants With Successful Gastric Drainage Tube Placement as Assessed by Fiberoptic Scope Visualization |
22; 2; 1 | — |
| SECONDARY Number of Attempts |
17; 21; 7; 3; 1; 1 | 0.03 sig |
Summary
The purpose of this study is to evaluate a new disposable supra-glottic airway device, the i-gel airway (Intersurgical Ltd., Wokingham, England). We propose to test its ease of insertion, position within the airway, drain tube patency and anatomic sealing properties during mechanical ventilation in non-obese anesthetized patients undergoing elective general surgery. The study device will be compared to the current standard in the industry, the LMA Unique.
Eligibility Criteria
Inclusion Criteria
- The subjects will be adult surgical candidates aged 18-80, ASA I-II, Mallampati I or II, presenting for elective surgery who require general anesthesia in whom tracheal intubation is not necessary.
- Both male and female patients will be included.
Exclusion Criteria
Patients will be excluded from the study if they present as Mallampati III or IV, ASA III-V or emergency status. Additionally, they will be excluded if they meet one of the contraindication criteria of the LMA including:
- obesity, (BMI > 35 kg/m2)
- pregnancy
- history of gastric regurgitation, heart burn, ileus or "full stomach"
- history of low pulmonary compliance or high pulmonary resistance
- known history of difficult endotracheal intubation or signs suggesting the possibility of difficult intubation
- pharyngeal pathology
- upper airway obstruction due to laryngeal pathology
Data sourced from ClinicalTrials.gov (NCT00706823). 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.