Laryngeal Mask Airway in Lower Abdominal Surgery

NCT02040324 | Completed

• 1 other identifier: LMA UKE
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Major Lower Abdominal Surgery

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (4)

• Vital capacity (VC) measured by spirometry.

  one day prior to surgery, i hour after 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

• Peak expiratory flow (PEF)

  one day prior to surgery, one hour after surgery (recovery room) , at day one after surgery

Study Arms (2)

Endotracheal Intubation

ACTIVE COMPARATOR

Clinical routine for longer lasting procedures

Device: Endotracheal tube

Laryngeal Mask

EXPERIMENTAL

Laryngeal mask with gastric access and drainage as airway management instead of endotracheal intubation

Device: Laryngeal mask with gastric access

Interventions

Laryngeal mask with gastric access DEVICE

Laryngeal Mask

Endotracheal tube DEVICE

Endotracheal Intubation

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

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

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

MeSH Terms

Interventions

Laryngeal Masks

Intervention Hierarchy (Ancestors)

Intubation, Intratracheal; Airway Management; Therapeutics; Intubation; Investigative Techniques; Masks; Protective Devices; Equipment and Supplies; Personal Protective Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Daniel A Reuter, MD, PhD

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: January 15, 2014
• First Posted: January 20, 2014
• Study Start: November 1, 2009
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2012
• Last Updated: January 20, 2014

Record last verified: 2014-01