Intubation Clinical Trial
— I-gelOfficial title:
A Randomized Clinical Comparison of the Intersurgical I-gel and the Laryngeal Mask Airway Unique in Non-Obese Adult Patients During General Surgery
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | August 2008 |
Est. primary completion date | August 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1. 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. 2. 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: 1. obesity, (BMI > 35 kg/m2) 2. pregnancy 3. history of gastric regurgitation, heart burn, ileus or "full stomach" 4. history of low pulmonary compliance or high pulmonary resistance 5. known history of difficult endotracheal intubation or signs suggesting the possibility of difficult intubation 6. pharyngeal pathology 7. upper airway obstruction due to laryngeal pathology |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Memorial Hermann Hospital | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Health Science Center, Houston |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time Required for Intubation | duration of intubation | No | |
Primary | Level of Difficulty for Intubation | duration of intubation | No | |
Primary | Degree of Throat Irritation | post operative, immediately and 24 hrs after intubation | Yes | |
Primary | Number of Attempts | The number of attempts taken to place the device | Before intubation | No |
Secondary | Leak Pressure | duration of intubation | No |
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