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NCT03984032 Clinical Trial

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

Anesthesia Clinical Trial

Official title:
Comparison of Clinical Performance of LMA Protector Cuff Pilot and LMA Supreme Among Anaesthetised, Non-Paralysed Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03984032
Other study ID # UKM PPI/111/8/JEP-2018-007
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 17, 2018
Est. completion date February 19, 2019

Study information
Verified date June 2019
Source Universiti Kebangsaan Malaysia Medical Centre
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date February 19, 2019
Est. primary completion date February 19, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• LMA Protector Cuff Pilot
Assessing the clinical performance of LMA Protector Cuff Pilot
• LMA Supreme
Assessing the clinical performance of LMA Supreme

Locations
Country Name City State
Malaysia Universiti Kebangsaan Malaysia Medical Centre Kuala Lumpur Wilayah Persekutuan

Sponsors (1)
Lead Sponsor Collaborator
Liu Chian Yong

Country where clinical trial is conducted

Malaysia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Oropharyngeal leak pressure (OLP) To assess the OLP of LMA Protector Cuff Pilot and LMA Supreme During induction of anaesthesia
Secondary Mean time to insertion To compare mean time to insertion of LMA Protector Cuff Pilot and LMA Supreme During induction of anaesthesia
Secondary Gastric tube insertion To compare the ease of gastric tube insertion in LMA Protector Cuff Pilot and LMA Supreme After induction of anaesthesia
Secondary Laryngeal view To compare the laryngeal view between LMA Protector Cuff Pilot and LMA Supreme After induction of anaesthesia
Secondary Complications To compare the incidence of sore throat and hoarseness of voice after insertion of LMA Protector Cuff Pilot and LMA Supreme 24 hours
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