Laryngeal Mask Airway in Lower Abdominal Surgery

January 16, 2014 updated by: Prof. Dr. med. Daniel Reuter, Universitätsklinikum Hamburg-Eppendorf

Comparison of Lung Function in Patients After Lower Abdominal Surgery Exceeding 2hrs Under the Use of Laryngeal Mask vs. Endotracheal Tube for Airway Management

We measure in this study lung function of 100 patients immediately after major lower abdominal surgery. We compare lung function, when either endotracheal intubation, or laryngeal masks are used for airway protection during surgery. The hypothesis is that the use of laryngeal masks is associated with less impairment of lung function in the immediate postoperative phase.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria - patients scheduled for elective retropubic radical prostatectomy

Exclusion Criteria:

- increased risk of aspiration due to hiatal hernia, morbid obesity, or facial malformations

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Endotracheal Intubation
Clinical routine for longer lasting procedures
Device: Endotracheal tube
EXPERIMENTAL: Laryngeal Mask
Laryngeal mask with gastric access and drainage as airway management instead of endotracheal intubation
Device: Laryngeal mask with gastric access

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change between pre- and postoperative forced expiratory volume in one second (FEV1) in lung function
Time Frame: one day prior to surgery, 1 hour after surgery (recovery room), at day one after surgery
The lung function is quantified by using Spirometry and pulse oximetry. Spirometry is performed in a standardized way according to the recommendations of the American Thoracic Society (ATS) and European Respiratory Society (ERS)
one day prior to surgery, 1 hour after surgery (recovery room), at day one after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vital capacity (VC) measured by spirometry.
Time Frame: one day prior to surgery, i hour after after surgery (recovery room), at day one after surgery
Spirometry is performed in a standardized way according to the recommendations of the American Thoracic Society (ATS) and European Respiratory Society (ERS)
one day prior to surgery, i hour after after surgery (recovery room), at day one after surgery
Forced vital capacity (FVC)
Time Frame: one day prior to surgery, one hour after surgery (recovery room), at day one after surgery
one day prior to surgery, one hour after surgery (recovery room), at day one after surgery
mid-expiratory flow (MEF 25, 50, 75)
Time Frame: one day prior to surgery, one hour after surgery, at day one after surgery
one day prior to surgery, one hour after surgery, at day one after surgery
Peak expiratory flow (PEF)
Time Frame: one day prior to surgery, one hour after surgery (recovery room) , at day one after surgery
one day prior to surgery, one hour after surgery (recovery room) , at day one after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Investigators

  • Principal Investigator: Daniel A Reuter, MD, PhD, Universitatsklinikum Hamburg-Eppendorf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (ACTUAL)

March 1, 2011

Study Completion (ACTUAL)

March 1, 2012

Study Registration Dates

First Submitted

January 15, 2014

First Submitted That Met QC Criteria

January 16, 2014

First Posted (ESTIMATE)

January 20, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

January 20, 2014

Last Update Submitted That Met QC Criteria

January 16, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • LMA UKE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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