The Laryngeal Tube Suction Versus Endotracheal Tube for Ventilation in Gynecological Laparoscopic Surgery
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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 |
- respiratory parameter [ Time Frame: 1-3 hours ] [ Designated as safety issue: Yes ]ETCO2, peak airway pressure and expired TV during operative period
- 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 |
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
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 June 18, 2013