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OpenTrials
Completed

NCT Number: NCT03984032

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

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

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Key information

Conditions

Anesthesia

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universiti Kebangsaan Malaysia Medical Centre

Kuala Lumpur, 56000, Malaysia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

LMA Protector Cuff Pilot

Device

Assessing the clinical performance of LMA Protector Cuff Pilot

LMA Supreme

Device

Assessing the clinical performance of LMA Supreme

Primary outcomes

  1. Oropharyngeal leak pressure (OLP)

    Time frame: During induction of anaesthesia

    To assess the OLP of LMA Protector Cuff Pilot and LMA Supreme

Secondary outcomes

  1. Mean time to insertion

    Time frame: During induction of anaesthesia

    To compare mean time to insertion of LMA Protector Cuff Pilot and LMA Supreme

  2. Gastric tube insertion

    Time frame: After induction of anaesthesia

    To compare the ease of gastric tube insertion in LMA Protector Cuff Pilot and LMA Supreme

  3. Laryngeal view

    Time frame: After induction of anaesthesia

    To compare the laryngeal view between LMA Protector Cuff Pilot and LMA Supreme

  4. Complications

    Time frame: 24 hours

    To compare the incidence of sore throat and hoarseness of voice after insertion of LMA Protector Cuff Pilot and LMA Supreme

Sponsors and collaborators

Lead sponsor

Liu Chian Yong

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 12, 2019
Registry last updated
Jun 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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