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Open Lung Approach During General Anaesthesia to Prevent Post-Operative Pulmonary Complications

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2007 by Università degli Studi dell'Insubria.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00426790
First Posted: January 25, 2007
Last Update Posted: January 25, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Università degli Studi dell'Insubria
  Purpose

The hypothesis of this study is that the "Open lung approach" ( recruitment and PEEP) during general anaesthesia reduces atelectasis formation and improves respiratory function in the immediate post-operative period after major abdominal surgery.

This is a prospective, randomized, controlled clinical-trial,performed in patients undergoing major abdominal surgery, to compare the effects on the post-operative pulmonary complications of two different intraoperative ventilatory strategies during general anaesthesia: 1- Control Group: PEEP 0 cmH2O without recruitment manoeuvre; 2- Treatment Group:recruitment manoeuvre (after intubation and before extubation) and PEEP 10 cmH2O In the post-operative period the following variables will be recorded at the first, third and fifth postoperative day: 1- Gas-exchange in air; 2- Chest X-ray for atelectasis evaluation; 3- signs of pulmonary complication (cough, secretions, dyspnea, thoracic pain)


Condition Intervention
Postoperative Complications Procedure: Positive end-expiratory pressure

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Università degli Studi dell'Insubria:

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with ASA 1, 2 and 3
  • Age higher than 18 years
  • Major abdominal surgery
  • General anesthesia

Exclusion Criteria:

  • COPD with FEV1 lower than 50%
  • Ischemic cardiopathy
  • Loco-regional anesthesia alone
  • Minor abdominal surgery
  • Laparoscopic surgery
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00426790


Contacts
Contact: Paolo Pelosi, Professor 0039-335-5941740 ppelosi@hotmail.com

Locations
Italy
Ospedale di Circolo e Fondazione Macchi Recruiting
Varese, Italy, 21100
Sponsors and Collaborators
Università degli Studi dell'Insubria
Investigators
Principal Investigator: Paolo Pelosi, Professor University of Insubria, Varese, Italy
  More Information

ClinicalTrials.gov Identifier: NCT00426790     History of Changes
Other Study ID Numbers: 1400
First Submitted: January 24, 2007
First Posted: January 25, 2007
Last Update Posted: January 25, 2007
Last Verified: January 2007

Additional relevant MeSH terms:
Postoperative Complications
Pathologic Processes