N/A N=80 Randomized Single-blind

Comparison of Clinical Performance of the Guardian Laryngeal Mask With LMA Proseal

Efficacy of Oropharyngeal Seal Pressure

Bottom Line

View on ClinicalTrials.gov: NCT02063516 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2014

Primary outcome: Primary: Oropharyngeal Seal Pressure — 32.36; 29.41 cmH2O — p=0.04

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Guardian Laryngeal Mask (Device); Proseal Laryngeal Mask Airway (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Tianjin Medical University General Hospital
Primary completion: Aug 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Oropharyngeal Seal Pressure	32.36; 29.41	0.04 sig
SECONDARY Anatomic Position	17; 14; 20; 21; 2; 3	0.836

Summary

To compare insertion characteristics of 2 different supraglottic devices (Guardian LMA and Proseal LMA) and to observe any associated complications.

Eligibility Criteria

Inclusion Criteria:• Ambulatory patients scheduled to undergo knee arthroscopy, transurethral resection of bladder tumor, hand, gynecological and general surgical under a short general paralysed anesthesia of less than 2 hours (American Society of Anesthesiologists physical status I-II)

18 to 65 years of age
Mallampati score less than 3
thyromental distance more than 6.5 cm
mouth opening more than >2.5 cm
a body mass index less than 35 kg/m2;

Exclusion Criteria

Body weight 50 Kg
Pregnancy
Difficult airway
Recent history of upper respiratory tract infection and sore throats
A history of esophageal reflux disease
ENT surgery
Laparoscopic surgery
Inability to understand the Study Information Sheet and provide a written consent to take part in the study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02063516). 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.