N/A Completed N=50 Randomized Single-blind Treatment

Comparison of I-gel to the Laryngeal Mask Airway

Endotracheal Intubation · Supraglottic Airway

Source: ClinicalTrials.gov NCT00706823 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2011

Primary outcomePrimary: Time Required for Intubation — 21.04; 30.04 seconds — p=0.02

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.

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

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.