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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
Università degli Studi dell'Insubria
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Complications

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
January 24, 2007
Last Updated
January 24, 2007
Sponsor
Università degli Studi dell'Insubria
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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
undefined (undefined)
Study Completion Date
undefined (undefined)

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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