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

January 15, 2014 updated by: Kelvin Quek How Yow, Changi General Hospital

The Laryngeal Mask Airway Supreme (TM) is an Effective Alternative to Laryngoscope-guided Tracheal Intubation for Patients Undergoing Elective Laparoscopic Cholecystectomy-- A Prospective Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 529889
        • Changi General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Laryngeal Mask Airway-Supreme
Patients who are randomly assigned to receive the LMA-Supreme
Device: Laryngeal Mask Airway-Supreme
Patients who receive the LMA-S
Other Names:
  • LMA-S
  • LMA-Supreme
  • LMA Supreme
Active Comparator: Endotracheal Tube
Patients who are randomly assigned to receive endotracheal intubation
Device: Endotracheal Tube
Patients who receive endotracheal intubation
Other Names:
  • ETT
  • Tracheal Tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Effective Airway
Time Frame: Baseline
Time to achieve effective airway was defined as time between removing the face-mask, inserting the airway device and obtaining a sustained square-wave capnograph trace with manual ventilation
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of attempts taken for successful placement of airway device
Time Frame: Baseline
Number of attempts needed for successful placement of either the LMA-Supreme or the tracheal tube, as assigned
Baseline
Number of attempts taken for successful placement of gastric tube
Time Frame: Baseline
Number of attempts needed for successful placement of gastric tube. Correct gastric tube placement was determined by positive suctioning of gastric contents or detection of injected air with epigastric auscultation.
Baseline
Haemodynamic response to insertion of airway device
Time Frame: Baseline, 1 min, 5 min
Systolic blood pressure and heart rate at 0 min, 1 min, 5 min, starting from the time the face mask was removed from the patient's face.
Baseline, 1 min, 5 min
Peak airway pressure during pneumoperitoneum
Time Frame: Assessed intra-operatively, during the period of pneumoperitoneum
Peak airway pressure recorded during pneumoperitoneum, measured during the surgery
Assessed intra-operatively, during the period of pneumoperitoneum
Incidence of post-operative sore throat
Time Frame: Assessed 1 hr after the surgery, at the Recovery Area
Patients were asked about the presence of sore throat - defined as the presence of constant pain in the throat, independent of swallowing, 1 hr after the end of surgery. No further follow-up.
Assessed 1 hr after the surgery, at the Recovery Area

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changi General Hospital

Investigators

  • Principal Investigator: Kelvin Quek, MMED (Anaes), Changi General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

January 14, 2014

First Submitted That Met QC Criteria

January 15, 2014

First Posted (Estimate)

January 16, 2014

Study Record Updates

Last Update Posted (Estimate)

January 16, 2014

Last Update Submitted That Met QC Criteria

January 15, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CGHLMAS2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cholecystitis

Clinical Trials on Laryngeal Mask Airway-Supreme

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cambodia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe