N/A
Completed N=100
Comparison Study of Two Supraglottic Airway Devices Used for Patients Under General Anesthesia
Anesthesia Airway Management
Source: ClinicalTrials.gov NCT01001078 ↗
Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Jan 2015
Primary outcomePrimary: Measure of the Airway Leak Pressure — 23; 21 cmH2O
Summary
This study will compare two supraglottic airway devices currently on the market. Supraglottic airway devices are used during general anesthesia to provide a patent airway. They are inserted blindly into the mouth once the patient has lost consciousness and they cover the laryngeal inlet. The I-Gel and the Supreme laryngeal mask airway (LMA) are the two devices to be compared. The I-Gel has no inflatable cuff, which makes it different from all other supraglottic airway devices currently in use. The Supreme shares some characteristics of the other LMA devices, but it is disposable. Our main goal will be to compare the airway leak pressure and the peak airway pressure of each devices. We will also measure the time needed for insertion, number of attempts needed to secure the airway and side effects related to the airway (cough, dysphagia, trauma, hoarseness of voice, sore throat).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measure of the Airway Leak Pressure |
23; 21 | — |
| SECONDARY Measure of the Peak Airway Pressure |
14; 14 | — |
| SECONDARY Time Needed to Secure the Airway |
19; 27 | — |
| SECONDARY Number of Participants With Successful Attempts to Introduce the Devices |
43; 44; 3; 2; 2; 3 | — |
| SECONDARY Adverse Effects After Anesthesia (Sore Throat, Cough, Dysphagia, Dysphonia) |
23; 26; 10; 13; 6; 4 | — |
| SECONDARY Airway Manipulation and Blood on Device at Removal |
2; 3; 5; 6 | — |
Eligibility Criteria
Inclusion Criteria
- Weight more than 50 kg;
- Body Mass Index less than 30;
- ASA I to III.
Exclusion Criteria
- Symptomatic gastro oesophageal reflux disease (GERD);
- Non fasted patients;
- Nasogastric tube in place;
- Intestinal obstruction;
- Ear, nose and throat surgery in the past or deformation of the airway;
- Known difficult airway (Cormack-Lehane grade 3-4);
- Oral cavity opening less than 3 cm;
- Pregnancy.
Data sourced from ClinicalTrials.gov (NCT01001078). 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.