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Completed

NCT Number: NCT02037958

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

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.

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Key information

Conditions

Cholecystitis Bile Duct Diseases Biliary Tract Diseases Choledocholithiasis Cholelithiasis Common Bile Duct Diseases Digestive System Diseases Gallbladder Diseases

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Changi General Hospital

Singapore, 529889

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Laryngeal Mask Airway-Supreme

Device

Patients who receive the LMA-S

Other names: LMA-S, LMA-Supreme, LMA Supreme

Endotracheal tube

Device

Patients who receive endotracheal intubation

Other names: ETT, Tracheal Tube

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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

  5. 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.

Sponsors and collaborators

Lead sponsor

Changi General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 16, 2014
Registry last updated
Jan 16, 2014

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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