LMA Protector Cuff Pilot vs LMA Supreme Among Anaesthetised, Non-Paralysed Patients

Not Applicable

Completed

• Conditions: Anesthesia
• Interventions: Device: LMA Supreme; Device: LMA Protector Cuff Pilot

• Registration Number: NCT03984032
• Lead Sponsor: Liu Chian Yong

Brief Summary

Comparison of clinical performance between LMA Protector Cuff Pilot and LMA Supreme in terms of oropharyngeal leak pressure, time to insertion, ease of gastric tube insertion, laryngeal view, incidence of sore throat

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-17
• Primary Completion: 2019-02-19
• Study Completion: 2019-02-19
• Study First Submitted: 2019-05-16
• Status Verified: 2019-06
• Study First Submitted QC: 2019-06-09
• Last Update Submitted: 2019-06-09
• Study First Posted: 2019-06-12
• Last Update Posted: 2019-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients planned for general anaesthesia without muscle relaxant usage via supraglottic airway device.

Exclusion Criteria

• BMI > 35
• Patients with likelihood of difficult intubation (Simplified Airway Risk Index Score of 4 or more)
• Patients with increased risks of aspirations (gastrooesophageal reflux disease, obstetric patients, hiatus hernia)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LMA Protector Cuff Pilot	LMA Supreme	-
LMA Supreme	LMA Protector Cuff Pilot	-

Primary Outcome Measures

Name	Time	Method
Oropharyngeal leak pressure (OLP)	During induction of anaesthesia	To assess the OLP of LMA Protector Cuff Pilot and LMA Supreme

Secondary Outcome Measures

Name	Time	Method
Mean time to insertion	During induction of anaesthesia	To compare mean time to insertion of LMA Protector Cuff Pilot and LMA Supreme
Laryngeal view	After induction of anaesthesia	To compare the laryngeal view between LMA Protector Cuff Pilot and LMA Supreme
Gastric tube insertion	After induction of anaesthesia	To compare the ease of gastric tube insertion in LMA Protector Cuff Pilot and LMA Supreme
Complications	24 hours	To compare the incidence of sore throat and hoarseness of voice after insertion of LMA Protector Cuff Pilot and LMA Supreme

Trial Locations

Locations (1)

Universiti Kebangsaan Malaysia Medical Centre; 🇲🇾 Kuala Lumpur, Wilayah Persekutuan, Malaysia