Laryngeal Mask Airway Supreme Versus the Tracheal Tube as an Airway Device in Elective Laparoscopic Cholecystectomy

NCT ID: NCT02037958

Last Updated: 2014-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-01-31

Brief Summary

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We hypothesise that the use of the LMA-Supreme provides greater ease of insertion and reduced haemodynamic variability during insertion compared to the tracheal tube, whilst still maintaining a patent airway to facilitate elective laparoscopic cholecystectomy in selected patients.

Detailed Description

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The Laryngeal Mask Airway Supreme(LMA-S) has been used successfully to maintain a patent airway for laparoscopic surgery. Our study compares the use of LMA-S with that of the tracheal tube (ETT) with respect to the ease of insertion and potential haemodynamic disturbance during insertion.

Conditions

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Cholecystitis Choledocholithiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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Laryngeal Mask Airway-Supreme

Patients who are randomly assigned to receive the LMA-Supreme

Group Type EXPERIMENTAL

Laryngeal Mask Airway-Supreme

Intervention Type DEVICE

Patients who receive the LMA-S

Endotracheal Tube

Patients who are randomly assigned to receive endotracheal intubation

Group Type ACTIVE_COMPARATOR

Endotracheal Tube

Intervention Type DEVICE

Patients who receive endotracheal intubation

Interventions

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Laryngeal Mask Airway-Supreme

Patients who receive the LMA-S

Intervention Type DEVICE

Endotracheal Tube

Patients who receive endotracheal intubation

Intervention Type DEVICE

Other Intervention Names

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LMA-S LMA-Supreme LMA Supreme ETT Tracheal Tube

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesiologists (ASA) Physical Status 1 and 2
* Undergoing elective laparoscopic cholecystectomy

Exclusion Criteria

* BMI \> 30
* Known gastro-oesophageal reflux disease
* predicted or documented difficult airway
* contraindications to drugs in the standardized anaesthesia protocol
Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Changi General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kelvin Quek How Yow

Consultant Anaesthetist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kelvin Quek, MMED (Anaes)

Role: PRINCIPAL_INVESTIGATOR

Changi General Hospital

Locations

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Changi General Hospital

Singapore, Singapore, Singapore

Site Status

Countries

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Singapore

Other Identifiers

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CGHLMAS2010

Identifier Type: -

Identifier Source: org_study_id

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