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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03984032
Recruitment Status : Completed
First Posted : June 12, 2019
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
Liu Chian Yong, Universiti Kebangsaan Malaysia Medical Centre

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

Condition or disease Intervention/treatment Phase
Anesthesia Device: LMA Protector Cuff Pilot Device: LMA Supreme Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Comparison of Clinical Performance of LMA Protector Cuff Pilot and LMA Supreme Among Anaesthetised, Non-Paralysed Patients
Actual Study Start Date : July 17, 2018
Actual Primary Completion Date : February 19, 2019
Actual Study Completion Date : February 19, 2019

Arm Intervention/treatment
Experimental: LMA Protector Cuff Pilot Device: LMA Supreme
Assessing the clinical performance of LMA Supreme

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




Primary Outcome Measures :
  1. Oropharyngeal leak pressure (OLP) [ Time Frame: During induction of anaesthesia ]
    To assess the OLP of LMA Protector Cuff Pilot and LMA Supreme


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03984032


Locations
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Malaysia
Universiti Kebangsaan Malaysia Medical Centre
Kuala Lumpur, Wilayah Persekutuan, Malaysia, 56000
Sponsors and Collaborators
Liu Chian Yong
  Study Documents (Full-Text)

Documents provided by Liu Chian Yong, Universiti Kebangsaan Malaysia Medical Centre:
Informed Consent Form  [PDF] July 14, 2018


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Responsible Party: Liu Chian Yong, Consultant Anaesthesiologist, Universiti Kebangsaan Malaysia Medical Centre
ClinicalTrials.gov Identifier: NCT03984032     History of Changes
Other Study ID Numbers: UKM PPI/111/8/JEP-2018-007
First Posted: June 12, 2019    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Liu Chian Yong, Universiti Kebangsaan Malaysia Medical Centre:
LMA Protector Cuff Pilot
LMA Supreme
Clinical Performance

Additional relevant MeSH terms:
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Chlorhexidine
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants