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出境医 / 临床实验 / LMA Protector Cuff Pilot vs LMA Supreme Among Anaesthetised, Non-Paralysed Patients

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

Study Description
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

Study Design
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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
Arms and Interventions
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
Outcome Measures
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


Eligibility Criteria
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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)
Contacts and Locations

Locations
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Malaysia
Universiti Kebangsaan Malaysia Medical Centre
Kuala Lumpur, Wilayah Persekutuan, Malaysia, 56000
Sponsors and Collaborators
Liu Chian Yong
Tracking Information
First Submitted Date  ICMJE May 16, 2019
First Posted Date  ICMJE June 12, 2019
Last Update Posted Date June 12, 2019
Actual Study Start Date  ICMJE July 17, 2018
Actual Primary Completion Date February 19, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 9, 2019) 		Oropharyngeal leak pressure (OLP) [ Time Frame: During induction of anaesthesia ]
To assess the OLP of LMA Protector Cuff Pilot and LMA Supreme
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2019)
  • Mean time to insertion [ Time Frame: During induction of anaesthesia ]
    To compare mean time to insertion of LMA Protector Cuff Pilot and LMA Supreme
  • 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
  • Laryngeal view [ Time Frame: After induction of anaesthesia ]
    To compare the laryngeal view between LMA Protector Cuff Pilot and LMA Supreme
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE LMA Protector Cuff Pilot vs LMA Supreme Among Anaesthetised, Non-Paralysed Patients
Official Title  ICMJE Comparison of Clinical Performance of LMA Protector Cuff Pilot and LMA Supreme Among Anaesthetised, Non-Paralysed Patients
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Condition  ICMJE Anesthesia
Intervention  ICMJE
  • Device: LMA Protector Cuff Pilot
    Assessing the clinical performance of LMA Protector Cuff Pilot
  • Device: LMA Supreme
    Assessing the clinical performance of LMA Supreme
Study Arms  ICMJE
  • Experimental: LMA Protector Cuff Pilot
    Intervention: Device: LMA Supreme
  • Active Comparator: LMA Supreme
    Intervention: Device: LMA Protector Cuff Pilot
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 9, 2019) 		60
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 19, 2019
Actual Primary Completion Date February 19, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Malaysia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03984032
Other Study ID Numbers  ICMJE UKM PPI/111/8/JEP-2018-007
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Liu Chian Yong, Universiti Kebangsaan Malaysia Medical Centre
Study Sponsor  ICMJE Liu Chian Yong
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Universiti Kebangsaan Malaysia Medical Centre
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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