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

Sponsor
Università degli Studi dell'Insubria (Other)
Overall Status
Unknown status
CT.gov ID
NCT00426790
Collaborator
(none)
1
Location

Study Details

Study Description

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
  • Procedure: Positive end-expiratory pressure
 N/A

Study Design

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

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Ospedale di Circolo e Fondazione Macchi Varese Italy 21100

    Sponsors and Collaborators

    • Università degli Studi dell'Insubria

    Investigators

    • Principal Investigator: Paolo Pelosi, Professor, University of Insubria, Varese, Italy

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00426790
    Other Study ID Numbers:
    • 1400
    First Posted:
    Jan 25, 2007
    Last Update Posted:
    Jan 25, 2007
    Last Verified:
    Jan 1, 2007
    Additional relevant MeSH terms:
    Postoperative Complications

    Study Results

    No Results Posted as of Jan 25, 2007