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

NCT ID: NCT00426790

Last Updated: 2007-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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)

Detailed Description

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Conditions

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Postoperative Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Positive end-expiratory pressure

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Università degli Studi dell'Insubria

OTHER

Sponsor Role lead

Principal Investigators

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Paolo Pelosi, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Insubria, Varese, Italy

Locations

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Ospedale di Circolo e Fondazione Macchi

Varese, Varese, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Paolo Pelosi, Professor

Role: CONTACT

0039-335-5941740

Other Identifiers

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1400

Identifier Type: -

Identifier Source: org_study_id

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