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

Cholecystitis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02037958
• Other study ID #: CGHLMAS2010
• Status: Completed
• Phase: N/A
• First received: January 14, 2014
• Last updated: January 15, 2014
• Start date: April 2011
• Est. completion date: January 2012

Study information

• Verified date: January 2014
• Source: Changi General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Cholecystitis
• Choledocholithiasis

Intervention

Device:
• Laryngeal Mask Airway-Supreme
Patients who receive the LMA-S
• Endotracheal Tube
Patients who receive endotracheal intubation

Locations

Country	Name	City	State
Singapore	Changi General Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Changi General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Effective Airway	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	No
Secondary	Number of attempts taken for successful placement of airway device	Number of attempts needed for successful placement of either the LMA-Supreme or the tracheal tube, as assigned	Baseline	No
Secondary	Number of attempts taken for successful placement of gastric tube	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	No
Secondary	Haemodynamic response to insertion of airway device	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	No
Secondary	Peak airway pressure during pneumoperitoneum	Peak airway pressure recorded during pneumoperitoneum, measured during the surgery	Assessed intra-operatively, during the period of pneumoperitoneum	No
Secondary	Incidence of post-operative sore throat	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	No