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

This study has been completed.
Sponsor:
Information provided by:
Prince of Songkla University
ClinicalTrials.gov Identifier:
NCT01345747
First received: April 25, 2011
Last updated: April 29, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention
Focus Groups
Device: laryngeal tube (VBM Medizintechnik, Sulz, Germany)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: The Laryngeal Tube Suction vs Endotracheal Tube for Ventilation in Gynecological Laparoscopic Surgery

Further study details as provided by Prince of Songkla University:

Primary Outcome Measures:
  • respiratory parameter [ Time Frame: 1-3 hours ] [ Designated as safety issue: Yes ]
    ETCO2, peak airway pressure and expired TV during operative period


Secondary Outcome Measures:
  • hemodynamic response [ Time Frame: 30 minutes ] [ Designated as safety issue: Yes ]
    blood pressure and heart rate after LT insertion


Enrollment: 120
Study Start Date: June 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: laryngeal tube
laryngeal tube suction has suction port
Device: laryngeal tube (VBM Medizintechnik, Sulz, Germany)
laryngeal tube suction number 3 and 4
Other Name: The laryngeal tube(VBM Medizintechnik, Sulz, Germany)
Experimental: endotracheal tube Device: laryngeal tube (VBM Medizintechnik, Sulz, Germany)
laryngeal tube suction number 3 and 4
Other Name: The laryngeal tube(VBM Medizintechnik, Sulz, Germany)

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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01345747

Locations
Thailand
Songklanagarind Hospital
Hatyai, Songkhla, Thailand, 90110
Sponsors and Collaborators
Prince of Songkla University
  More Information

No publications provided

Responsible Party: Assistant Professor Nalinee Kovitwanawong, Department of Anesthesiology Faculty of Medicine Prince of Songkla University Thailand
ClinicalTrials.gov Identifier: NCT01345747     History of Changes
Other Study ID Numbers: LT-Laparo
Study First Received: April 25, 2011
Last Updated: April 29, 2011
Health Authority: Thailand: Ethical Committee

Keywords provided by Prince of Songkla University:
laryngeal tube suction
gynecology
laparoscopic surgery

ClinicalTrials.gov processed this record on October 23, 2014