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.

Study Overview

• Status: Unknown
• Conditions: 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
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Harald Groeben, Prof. Dr.; Phone Number: 31109 ##49201174; Email: h.groeben@kliniken-essen-mitte.de

Study Locations

• Germany
  • Essen, Germany, 45136
    • Recruiting
    • Prof. Dr. Harald Groeben
    • Contact: Harald Groeben, Prof. Dr.; Phone Number: 31109 ##49201174; Email: h.groeben@kliniken-essen-mitte.de
    • Principal Investigator: Harald Groeben, Prof. Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Measurement of FEV1 (forced expiratory volume in one second) and the MEF50/MIF50 ratio	18 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in nasal airway resistance	18 months

Collaborators and Investigators

• Sponsor: Kliniken Essen-Mitte
• Investigators: Principal Investigator: Harald Groeben, Prof. Dr., Klniken Essen-Mitte

Publications and helpful links

General Publications

• Craig DB. Postoperative recovery of pulmonary function. Anesth Analg. 1981 Jan;60(1):46-52. No abstract available.
• Herbstreit F, Peters J, Eikermann M. Impaired upper airway integrity by residual neuromuscular blockade: increased airway collapsibility and blunted genioglossus muscle activity in response to negative pharyngeal pressure. Anesthesiology. 2009 Jun;110(6):1253-60. doi: 10.1097/ALN.0b013e31819faa71.
• Chiu KL, Ryan CM, Shiota S, Ruttanaumpawan P, Arzt M, Haight JS, Chan CT, Floras JS, Bradley TD. Fluid shift by lower body positive pressure increases pharyngeal resistance in healthy subjects. Am J Respir Crit Care Med. 2006 Dec 15;174(12):1378-83. doi: 10.1164/rccm.200607-927OC. Epub 2006 Sep 22.

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Anticipated): October 1, 2011
• Study Completion (Anticipated): February 1, 2012

Study Registration Dates

• First Submitted: July 28, 2009
• First Submitted That Met QC Criteria: July 28, 2009
• First Posted (Estimate): July 29, 2009

Study Record Updates

• Last Update Posted (Estimate): June 28, 2011
• Last Update Submitted That Met QC Criteria: June 27, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: Vital capacity, FEV1, airway resistance; perioperative changes in lung function
• Additional Relevant MeSH Terms: Digestive System Diseases; Peritoneal Diseases; Pneumoperitoneum
• Other Study ID Numbers: 06-3085

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No