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Influence of Posture and Gas Insufflation on Perioperative Lung Function

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2011 by Kliniken Essen-Mitte.
Recruitment status was:  Recruiting
Information provided by:
Kliniken Essen-Mitte Identifier:
First received: July 28, 2009
Last updated: June 27, 2011
Last verified: June 2011
Perioperative airway resistance and lung function are evaluated perioperatively in patients, who undergo surgical procedures in different postures and with or without gas insufflation into the peritoneal cavity.


Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Influence of Posture, Anesthesia and Surgical Technique on Airway Resistance of the Upper and Lower Airway and Lung Function.

Further study details as provided by Kliniken Essen-Mitte:

Primary Outcome Measures:
  • Measurement of FEV1 (forced expiratory volume in one second) and the MEF50/MIF50 ratio [ Time Frame: 18 months ]

Secondary Outcome Measures:
  • Changes in nasal airway resistance [ Time Frame: 18 months ]

Estimated Enrollment: 60
Study Start Date: April 2009
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
head down, laparoscopic
20 patients with laparoscopic surgery (radical robotic prostatectomy) in head down position
head down, open
20 patients undergoing "open"surgery (open radical prostatectomy) in head down position.
horizontal, open
20 patients undergoing "open" surgery in horizontal position (open hemicolectomy)

Detailed Description:
Lung function, upper and lower airway resistance measurements are performed in patients in prone horizontal or head tilted down (40°) position. Half of the patients with head down position will have surgery in laparoscopic technique (including gas insufflation to achieve a pneumoperitoneum). Measurements are performed on the day prior to surgery, on the morning of surgery, 30 - 45 minutes, 2 hours, and 24 hours after extubation.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
20 patients scheduled for "robotic" prostatectomies 20 patients scheduled for open prostatectomies 20 patients scheduled for open hemicolectomies

Inclusion Criteria:

  • Patients older than 18 years of age.
  • Patients with normal lung function with respect to age, gender and weight. -Patients scheduled for Prostatectomies, robotic Prostatectomies, and open hemicolectomies.

Exclusion Criteria:

  • Patients younger than 18 years.
  • Patients with pathological lung function.
  • Patients with with major cardiac disease.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00948571

Contact: Harald Groeben, Prof. Dr. ##49201174 ext 31109

Prof. Dr. Harald Groeben Recruiting
Essen, Germany, 45136
Contact: Harald Groeben, Prof. Dr.    ##49201174 ext 31109   
Principal Investigator: Harald Groeben, Prof. Dr.         
Sponsors and Collaborators
Kliniken Essen-Mitte
Principal Investigator: Harald Groeben, Prof. Dr. Klniken Essen-Mitte
  More Information

Responsible Party: Prof. Dr. Harald Groeben, Kliniken Essen-Mitte Identifier: NCT00948571     History of Changes
Other Study ID Numbers: 06-3085
Study First Received: July 28, 2009
Last Updated: June 27, 2011

Keywords provided by Kliniken Essen-Mitte:
Vital capacity, FEV1, airway resistance
perioperative changes in lung function

Additional relevant MeSH terms:
Peritoneal Diseases
Digestive System Diseases processed this record on September 21, 2017