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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endotracheal Intubation | Active Comparator | Clinical routine for longer lasting procedures |
|
| Laryngeal Mask | Experimental | Laryngeal mask with gastric access and drainage as airway management instead of endotracheal intubation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laryngeal mask with gastric access | Device |
| ||
| Endotracheal tube |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Vital capacity (VC) measured by spirometry. | 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) |
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Inclusion Criteria - patients scheduled for elective retropubic radical prostatectomy
Exclusion Criteria:
- increased risk of aspiration due to hiatal hernia, morbid obesity, or facial malformations
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| Name | Affiliation | Role |
|---|---|---|
| Daniel A Reuter, MD, PhD | Universitätsklinikum Hamburg-Eppendorf | Principal Investigator |
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| ID | Term |
|---|---|
| D017214 | Laryngeal Masks |
| ID | Term |
|---|---|
| D007442 | Intubation, Intratracheal |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D007440 | Intubation |
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| Device |
|
| 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 |
| D008919 |
| Investigative Techniques |
| D008397 | Masks |
| D011482 | Protective Devices |
| D004864 | Equipment and Supplies |
| D000067393 | Personal Protective Equipment |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |