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OpenTrials
Completed

NCT Number: NCT02040324

Laryngeal Mask Airway in Lower Abdominal Surgery

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.

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Key information

Conditions

Major Lower Abdominal Surgery

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

- patients scheduled for elective retropubic radical prostatectomy

Exclusion criteria

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

Treatment and study plan

Laryngeal mask with gastric access

Device

Endotracheal tube

Device

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. Forced vital capacity (FVC)

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

  3. mid-expiratory flow (MEF 25, 50, 75)

    Time frame: one day prior to surgery, one hour after surgery, at day one after surgery

  4. Peak expiratory flow (PEF)

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

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Jan 20, 2014
Registry last updated
Jan 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.