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

Focus Groups Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01345747
• Other study ID #: LT-Laparo
• Status: Completed
• Phase: N/A
• First received: April 25, 2011
• Last updated: April 29, 2011
• Start date: June 2008
• Est. completion date: July 2009

Study information

• Verified date: April 2011
• Source: Prince of Songkla University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 65 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Focus Groups

Intervention

Device:
• laryngeal tube (VBM Medizintechnik, Sulz, Germany)
laryngeal tube suction number 3 and 4

Locations

Country	Name	City	State
Thailand	Songklanagarind Hospital	Hatyai	Songkhla

Sponsors (1)

Lead Sponsor	Collaborator
Prince of Songkla University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	respiratory parameter	ETCO2, peak airway pressure and expired TV during operative period	1-3 hours	Yes
Secondary	hemodynamic response	blood pressure and heart rate after LT insertion	30 minutes	Yes