NCT00948571

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 29, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

June 28, 2011

Status Verified

June 1, 2011

Enrollment Period

2.5 years

First QC Date

July 28, 2009

Last Update Submit

June 27, 2011

Conditions

Pneumoperitoneum

Keywords

Vital capacity, FEV1, airway resistanceperioperative changes in lung function

Outcome Measures

Primary Outcomes (1)

  • Measurement of FEV1 (forced expiratory volume in one second) and the MEF50/MIF50 ratio

    18 months

Secondary Outcomes (1)

  • Changes in nasal airway resistance

    18 months

Study Arms (3)

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)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • Patients younger than 18 years.
  • Patients with pathological lung function.
  • Patients with with major cardiac disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof. Dr. Harald Groeben

Essen, 45136, Germany

RECRUITING

Related Publications (3)

  • Craig DB. Postoperative recovery of pulmonary function. Anesth Analg. 1981 Jan;60(1):46-52. No abstract available.

    PMID: 7006464BACKGROUND

  • 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.

    PMID: 19417617BACKGROUND

  • 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.

    PMID: 16998093BACKGROUND

MeSH Terms

Conditions

Pneumoperitoneum

Condition Hierarchy (Ancestors)

Peritoneal DiseasesDigestive System Diseases

Study Officials

  • Harald Groeben, Prof. Dr.

    Klniken Essen-Mitte

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Harald Groeben, Prof. Dr.

CONTACT

##49201174h.groeben@kliniken-essen-mitte.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 28, 2009

First Posted

July 29, 2009

Study Start

April 1, 2009

Primary Completion

October 1, 2011

Study Completion

February 1, 2012

Last Updated

June 28, 2011

Record last verified: 2011-06

Locations

DE(1)