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Influence of Posture and Gas Insufflation on Perioperative Lung Function

This study is currently recruiting participants.
Verified June 2011 by Kliniken Essen-Mitte
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
History of Changes
  Purpose

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
Pneumoperitoneum

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.

Resource links provided by NLM:

MedlinePlus related topics: Gas
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in nasal airway resistance [ Time Frame: 18 months ] [ Designated as safety issue: No ]

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)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:

Responsible Party: Prof. Dr. Harald Groeben, Kliniken Essen-Mitte
ClinicalTrials.gov Identifier: NCT00948571     History of Changes
Other Study ID Numbers: 06-3085
Study First Received: July 28, 2009
Last Updated: June 27, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Pneumoperitoneum
Peritoneal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 21, 2013