Influence of Posture and Gas Insufflation on Perioperative Lung Function

Pneumoperitoneum Clinical Trial

Official title:

Influence of Posture, Anesthesia and Surgical Technique on Airway Resistance of the Upper and Lower Airway and Lung Function.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00948571
• Other study ID #: 06-3085
• Status: Recruiting
• Phase: N/A
• First received: July 28, 2009
• Last updated: June 27, 2011
• Start date: April 2009
• Est. completion date: February 2012

Study information

• Verified date: June 2011
• Source: Kliniken Essen-Mitte
• Contact: Harald Groeben, Prof. Dr.
• Phone: ##49201174
• Email: h.groeben[@]kliniken-essen-mitte.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pneumoperitoneum

Locations

Country	Name	City	State
Germany	Prof. Dr. Harald Groeben	Essen

Sponsors (1)

Lead Sponsor	Collaborator
Kliniken Essen-Mitte

Country where clinical trial is conducted

Germany, 

References & Publications (3)

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. Epub 2006 Sep 22. — View Citation

Craig DB. Postoperative recovery of pulmonary function. Anesth Analg. 1981 Jan;60(1):46-52. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of FEV1 (forced expiratory volume in one second) and the MEF50/MIF50 ratio		18 months	No
Secondary	Changes in nasal airway resistance		18 months	No