Open Lung Approach During General Anaesthesia to Prevent Post-Operative Pulmonary Complications
Primary Purpose
Postoperative Complications
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Positive end-expiratory pressure
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Complications
Eligibility 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
Sites / Locations
- Ospedale di Circolo e Fondazione MacchiRecruiting
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00426790
First Posted
January 24, 2007
Last Updated
January 24, 2007
Sponsor
Università degli Studi dell'Insubria
1. Study Identification
Unique Protocol Identification Number
NCT00426790
Brief Title
Open Lung Approach During General Anaesthesia to Prevent Post-Operative Pulmonary Complications
Study Type
Interventional
2. Study Status
Record Verification Date
January 2007
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
Università degli Studi dell'Insubria
4. Oversight
5. 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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Positive end-expiratory pressure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paolo Pelosi, Professor
Phone
0039-335-5941740
Email
ppelosi@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paolo Pelosi, Professor
Organizational Affiliation
University of Insubria, Varese, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale di Circolo e Fondazione Macchi
City
Varese
ZIP/Postal Code
21100
Country
Italy
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Open Lung Approach During General Anaesthesia to Prevent Post-Operative Pulmonary Complications
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