Trials / Completed
CompletedNCT03251105
Supreme Versus Proseal Laryngeal Mask Airways in Infants
Comparison of the Supreme™ And Proseal™ Laryngeal Mask Airways in Infants: A Prospective Randomised Clinical Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 120 (actual)
- Sponsor
- Sisli Hamidiye Etfal Training and Research Hospital · Academic / Other
- Sex
- All
- Age
- 12 Months
- Healthy volunteers
- Accepted
Summary
In this study, the Supreme and ProSeal LMAs in infants were compared by measuring their performance characteristics, including insertion features, ventilation parameters, induced changes in hemodynamics and rates of postoperative complications.
Detailed description
Both the Supreme™ and ProSeal™ laryngeal mask airways (LMAs) are widely used for paediatric anaesthesia; however, LMA use in infants is limited, as many anaesthesiologists prefer to use tracheal intubation in infants. In this study, the Supreme and ProSeal LMAs in infants were compared by measuring their performance characteristics, including insertion features, ventilation parameters, induced changes in hemodynamics and rates of postoperative complications. Infants of ASA physical status I who were scheduled for elective, minor, lower abdominal surgery were divided into two groups: the Supreme LMA group and the ProSeal LMA group. Heart rate (HR), oxygen saturation and end tidal carbon dioxide values were recorded both before and after LMA insertion, as well as both before and after extubation. After extubation, complications and adverse effects were noted. Demographics and surgical data were similar between the two groups. LMA insertion times for the ProSeal group were shorter, the leakage pressure for the ProSeal group was statistically higher. The ProSeal LMA is superior to the Supreme LMA for use in infants, due to its ease of insertion, high oropharyngeal leakage pressure and fewer induced changes in hemodynamics.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | supraglottic airway intubation |
Timeline
- Start date
- 2016-04-27
- Primary completion
- 2016-12-31
- Completion
- 2017-01-31
- First posted
- 2017-08-16
- Last updated
- 2017-08-16
Source: ClinicalTrials.gov record NCT03251105. Inclusion in this directory is not an endorsement.