The Laryngeal Tube Suction Versus Endotracheal Tube for Ventilation in Gynecological Laparoscopic Surgery

Not Applicable

Completed

• Conditions: Focus Groups
• Interventions: Device: laryngeal tube (VBM Medizintechnik, Sulz, Germany)

• Registration Number: NCT01345747
• Lead Sponsor: Prince of Songkla University

Brief Summary

This study the investigators compare peak airway pressure (PAP), expire tidal volume (TV), end tidal CO2 (ETCO2), SpO2, mean arterial pressure (MAP) and heart rate (HR) after the insertion of laryngeal tube suction or endotracheal tube in patients undergoing elective gynecological laparoscopic surgery.

Detailed Description

Background:

For standard procedure, the endotracheal tube is used to ventilate the anesthetized patients who undergo gynecological laparoscopic surgery that increase intrabdominal pressure. Now there is a new supraglottic airway device, laryngeal tube suction (LTs) can be use instead of ETT.

Objective This study the investigators compare peak airway pressure (PAP), expire tidal volume (TV), end tidal CO2 (ETCO2), SpO2, mean arterial pressure (MAP) and heart rate (HR) after the insertion of laryngeal tube suction or endotracheal tube in patients undergoing elective gynecological laparoscopic surgery.

Material and methods Prospective single blinded randomized control trial, the patients were divided into two groups, LTs group and ETT group n = 60 for each group. All patients were induced anesthesia with fentanyl 1-2 mcg/kg, propofol 2 mg/kg, vecuronium 0.1 mg/kg then maintained anesthesia with air : oxygen 30%. Respirator setting are tidal volume 10 ml/kg, I/E 1:2 adjust RR base on ETCO2 keep ETCO2 35-40 mmHg.

Results No statistical difference in demographic data between groups. PAP and ETCO2 in the LTs group were significant higher than ETT group in the first 5 and 10 minutes but no statistically significant after 10 minutes until the end of operation. No statistically significant in TV and SpO2 between groups. In ETT group MAP and HR after insertion are significant higher than LTs group, no statistically significant about postoperative complication such as sorethroat, hoarseness and nausea vomiting.

Conclusion LTs can be used in gynecological laparoscopic surgery like ETT.

Study Timeline

• Study Start: 2008-06
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2011-04
• Study First Submitted: 2011-04-25
• Study First Submitted QC: 2011-04-29
• Last Update Submitted: 2011-04-29
• Study First Posted: 2011-05-02
• Last Update Posted: 2011-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• female age between 20-65 years
• ASA class 1-2
• elective gynecologic laparoscopic surgery
• height < 180 cm
• BMI < 35 kg/m2

Exclusion Criteria

• interincisor gap < 2.5 cm
• risk of aspiration
• history of difficult intubation
• oropharyngeal pathology
• allergy to anesthetic drug

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
laryngeal tube	laryngeal tube (VBM Medizintechnik, Sulz, Germany)	laryngeal tube suction has suction port
endotracheal tube	laryngeal tube (VBM Medizintechnik, Sulz, Germany)	-

Primary Outcome Measures

Name	Time	Method
respiratory parameter	1-3 hours	ETCO2, peak airway pressure and expired TV during operative period

Secondary Outcome Measures

Name	Time	Method
hemodynamic response	30 minutes	blood pressure and heart rate after LT insertion

Trial Locations

Locations (1)

Songklanagarind Hospital; 🇹🇭 Hatyai, Songkhla, Thailand