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NCT00426790 Clinical Trial

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

Postoperative Complications Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00426790
Other study ID # 1400
Secondary ID
Status Recruiting
Phase N/A
First received January 24, 2007
Last updated January 24, 2007

Study information
Verified date January 2007
Source Università degli Studi dell'Insubria
Contact Paolo Pelosi, Professor
Phone 0039-335-5941740
Email ppelosi@hotmail.com
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical Trial 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)

Recruitment information / eligibility
Status Recruiting
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Positive end-expiratory pressure

Locations
Country Name City State
Italy Ospedale di Circolo e Fondazione Macchi Varese

Sponsors (1)
Lead Sponsor Collaborator
Università degli Studi dell'Insubria

Country where clinical trial is conducted

Italy, 

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