Laryngeal Mask Airway in Lower Abdominal Surgery

Not Applicable

Completed

• Conditions: Major Lower Abdominal Surgery
• Interventions: Device: Endotracheal tube; Device: Laryngeal mask with gastric access

• Registration Number: NCT02040324
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Primary Completion: 2011-03
• Study Completion: 2012-03
• Status Verified: 2014-01
• Study First Submitted: 2014-01-15
• Study First Submitted QC: 2014-01-16
• Last Update Submitted: 2014-01-16
• Study First Posted: 2014-01-20
• Last Update Posted: 2014-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endotracheal Intubation	Endotracheal tube	Clinical routine for longer lasting procedures
Laryngeal Mask	Laryngeal mask with gastric access	Laryngeal mask with gastric access and drainage as airway management instead of endotracheal intubation

Primary Outcome Measures

Name	Time	Method
The change between pre- and postoperative forced expiratory volume in one second (FEV1) in lung function	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)

Secondary Outcome Measures

Name	Time	Method
Vital capacity (VC) measured by spirometry.	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)
Peak expiratory flow (PEF)	one day prior to surgery, one hour after surgery (recovery room) , at day one after surgery
Forced vital capacity (FVC)	one day prior to surgery, one hour after surgery (recovery room), at day one after surgery
mid-expiratory flow (MEF 25, 50, 75)	one day prior to surgery, one hour after surgery, at day one after surgery