NCT00426790

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)

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 25, 2007

Completed
Last Updated

January 25, 2007

Status Verified

January 1, 2007

First QC Date

January 24, 2007

Last Update Submit

January 24, 2007

Conditions

Postoperative Complications

Interventions

Positive end-expiratory pressurePROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with ASA 1, 2 and 3
  • Age higher than 18 years
  • Major abdominal surgery
  • General anesthesia

You may not qualify if:

  • COPD with FEV1 lower than 50%
  • Ischemic cardiopathy
  • Loco-regional anesthesia alone
  • Minor abdominal surgery
  • Laparoscopic surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ospedale di Circolo e Fondazione Macchi

Varese, Varese, 21100, Italy

RECRUITING

MeSH Terms

Conditions

Postoperative Complications

Interventions

Positive-Pressure Respiration

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Paolo Pelosi, Professor

    University of Insubria, Varese, Italy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paolo Pelosi, Professor

CONTACT

0039-335-5941740ppelosi@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 24, 2007

First Posted

January 25, 2007

Last Updated

January 25, 2007

Record last verified: 2007-01

Locations

IT(1)