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

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ClinicalTrials.gov Identifier: NCT00426790
Recruitment Status : Unknown
Verified January 2007 by Università degli Studi dell'Insubria.
Recruitment status was:  Recruiting
First Posted : January 25, 2007
Last Update Posted : January 25, 2007
Sponsor:
Information provided by:
Università degli Studi dell'Insubria

Brief Summary:

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 or disease Intervention/treatment Phase
Postoperative Complications Procedure: Positive end-expiratory pressure Not Applicable

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery





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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

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

Additional relevant MeSH terms:
Postoperative Complications
Pathologic Processes