Influence of Posture and Gas Insufflation on Perioperative Lung Function

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Kliniken Essen-Mitte.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Kliniken Essen-Mitte
ClinicalTrials.gov Identifier:
NCT00948571
First received: July 28, 2009
Last updated: June 27, 2011
Last verified: June 2011

July 28, 2009
June 27, 2011
April 2009
October 2011   (final data collection date for primary outcome measure)
Measurement of FEV1 (forced expiratory volume in one second) and the MEF50/MIF50 ratio [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00948571 on ClinicalTrials.gov Archive Site
Changes in nasal airway resistance [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Influence of Posture and Gas Insufflation on Perioperative Lung Function
Influence of Posture, Anesthesia and Surgical Technique on Airway Resistance of the Upper and Lower Airway and Lung Function.

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

20 patients scheduled for "robotic" prostatectomies 20 patients scheduled for open prostatectomies 20 patients scheduled for open hemicolectomies

Pneumoperitoneum
Not Provided
  • 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)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
February 2012
October 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Harald Groeben, Prof. Dr. ##49201174 ext 31109 h.groeben@kliniken-essen-mitte.de
Germany
 
NCT00948571
06-3085
No
Prof. Dr. Harald Groeben, Kliniken Essen-Mitte
Kliniken Essen-Mitte
Not Provided
Principal Investigator: Harald Groeben, Prof. Dr. Klniken Essen-Mitte
Kliniken Essen-Mitte
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP