NCT01345747

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

April 25, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 2, 2011

Completed
Last Updated

May 2, 2011

Status Verified

April 1, 2011

Enrollment Period

1.1 years

First QC Date

April 25, 2011

Last Update Submit

April 29, 2011

Conditions

Focus Groups

Keywords

laryngeal tube suctiongynecologylaparoscopic surgery

Outcome Measures

Primary Outcomes (1)

  • respiratory parameter

    ETCO2, peak airway pressure and expired TV during operative period

    1-3 hours

Secondary Outcomes (1)

  • hemodynamic response

    30 minutes

Study Arms (2)

laryngeal tube

EXPERIMENTAL

laryngeal tube suction has suction port

Device: laryngeal tube (VBM Medizintechnik, Sulz, Germany)

endotracheal tube

EXPERIMENTAL
Device: laryngeal tube (VBM Medizintechnik, Sulz, Germany)

Interventions

laryngeal tube (VBM Medizintechnik, Sulz, Germany)DEVICE

laryngeal tube suction number 3 and 4

Also known as: The laryngeal tube(VBM Medizintechnik, Sulz, Germany)
endotracheal tubelaryngeal tube

Eligibility Criteria

Age20 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Songklanagarind Hospital

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 25, 2011

First Posted

May 2, 2011

Study Start

June 1, 2008

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

May 2, 2011

Record last verified: 2011-04

Locations

TH(1)