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

Not Applicable

Completed

• Conditions: Cholecystitis; Choledocholithiasis
• Interventions: Device: Laryngeal Mask Airway-Supreme; Device: Endotracheal Tube

• Registration Number: NCT02037958
• Lead Sponsor: Changi General Hospital

Brief Summary

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

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 Timeline

• Study Start: 2011-04
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2014-01
• Study First Submitted: 2014-01-14
• Study First Submitted QC: 2014-01-15
• Last Update Submitted: 2014-01-15
• Study First Posted: 2014-01-16
• Last Update Posted: 2014-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Laryngeal Mask Airway-Supreme	Laryngeal Mask Airway-Supreme	Patients who are randomly assigned to receive the LMA-Supreme
Endotracheal Tube	Endotracheal Tube	Patients who are randomly assigned to receive endotracheal intubation

Primary Outcome Measures

Name	Time	Method
Time to Effective Airway	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 Outcome Measures

Name	Time	Method
Number of attempts taken for successful placement of airway device	Baseline	Number of attempts needed for successful placement of either the LMA-Supreme or the tracheal tube, as assigned
Peak airway pressure during pneumoperitoneum	Assessed intra-operatively, during the period of pneumoperitoneum	Peak airway pressure recorded during pneumoperitoneum, measured during the surgery
Incidence of post-operative sore throat	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.
Number of attempts taken for successful placement of gastric tube	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.
Haemodynamic response to insertion of airway device	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.

Trial Locations

Locations (1)

Changi General Hospital; 🇸🇬 Singapore, Singapore