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Influence of Posture and Gas Insufflation on Perioperative Lung Function

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ClinicalTrials.gov Identifier: NCT00948571
Recruitment Status : Unknown
Verified June 2011 by Kliniken Essen-Mitte.
Recruitment status was:  Recruiting
First Posted : July 29, 2009
Last Update Posted : June 28, 2011
Sponsor:
Information provided by:
Kliniken Essen-Mitte

Brief Summary:
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.

Condition or disease
Pneumoperitoneum

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.

Study Type : Observational
Estimated Enrollment : 60 participants
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.
Study Start Date : April 2009
Estimated Primary Completion Date : October 2011
Estimated Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
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)



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

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


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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
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00948571


Contacts
Contact: Harald Groeben, Prof. Dr. ##49201174 ext 31109 h.groeben@kliniken-essen-mitte.de

Locations
Germany
Prof. Dr. Harald Groeben Recruiting
Essen, Germany, 45136
Contact: Harald Groeben, Prof. Dr.    ##49201174 ext 31109    h.groeben@kliniken-essen-mitte.de   
Principal Investigator: Harald Groeben, Prof. Dr.         
Sponsors and Collaborators
Kliniken Essen-Mitte
Investigators
Principal Investigator: Harald Groeben, Prof. Dr. Klniken Essen-Mitte