Laryngeal Mask Airway in Lower Abdominal Surgery

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02040324

Enrollment

100

Registered

2014-01-20

Start date

2009-11-30

Completion date

2012-03-31

Last updated

2014-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Lower Abdominal Surgery

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.

Interventions

DEVICELaryngeal mask with gastric access

DEVICEEndotracheal tube

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

- patients scheduled for elective retropubic radical prostatectomy

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)
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	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026