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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by Università degli Studi dell'Insubria.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Università degli Studi dell'Insubria
ClinicalTrials.gov Identifier:
NCT00426790
First received: January 24, 2007
Last updated: NA
Last verified: January 2007
History: No changes posted

January 24, 2007
January 24, 2007
Not Provided
Not Provided
Not Provided
Not Provided
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Open Lung Approach During General Anaesthesia to Prevent Post-Operative Pulmonary Complications
Not Provided

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)

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Postoperative Complications
Procedure: Positive end-expiratory pressure
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
Not Provided
Not Provided
Not Provided

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
Both
18 Years and older
No
Contact: Paolo Pelosi, Professor 0039-335-5941740 ppelosi@hotmail.com
Italy
 
NCT00426790
1400
Not Provided
Not Provided
Università degli Studi dell'Insubria
Not Provided
Principal Investigator: Paolo Pelosi, Professor University of Insubria, Varese, Italy
Università degli Studi dell'Insubria
January 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP