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Postoperative Pulmonary Complications in Abdominal Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01701908
Recruitment Status : Unknown
Verified October 2012 by Giorgio Della Rocca, University of Udine.
Recruitment status was:  Not yet recruiting
First Posted : October 5, 2012
Last Update Posted : October 8, 2012
Sponsor:
Information provided by (Responsible Party):
Giorgio Della Rocca, University of Udine

Brief Summary:

Incidence of Postoperative Pulmonary Complications (PPCs) varies from 2% to 19%, according to the population under examination and the criteria used to define pulmonary complications. There is no univocal definition of PPCs. Usually physicians associate atelectasis, respiratory insufficiency, pneumonia, bronchospasm, necessity to reintubate. Moreover the evaluation of risk factors has become difficult.

The endpoint of this study is to determine the actual incidence of respiratory postoperative complications in patients undergoing general anesthesia for major abdominal surgery (general surgery, gynecology, urology).

This is an observational, descriptive, prospective, multicentric study. Investigators are going to enroll all the patients matching the inclusion criteria and follow them until discharge (clinical phase). Then they will be followed up until one year later.


Condition or disease
Postoperative Pulmonary Complications

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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Postoperative Pulmonary Complications in Major (Abdominal) Surgery: a Multicenter Study
Study Start Date : January 2013
Estimated Primary Completion Date : December 2013




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
1500 patients undergoing elective major abdominal surgery, urologic surgery or major gynecological surgery under general anaesthesia.
Criteria

Inclusion Criteria:

  • Patients ≥ 18 years
  • Ability to provide informed consent
  • Elective surgery
  • Laparotomic or laparoscopic major abdominal surgery
  • Major urological surgery (performed under general anesthesia)
  • Major gynecological surgery (performed under general anesthesia)

Exclusion Criteria:

  • Patients undergoing urgent or emergent surgery
  • Patients undergoing: vascular, thoracic ,cardiac surgery, neurosurgery, obstetrics procedures and transplantation surgery
  • Patients with chronic neuro-muscular junction disorders
  • Immunocompromised or immunodepressed patients
  • Patients with chronic or acute respiratory disease (acute respiratory infection, bronchial asthma, chronic obstructive pulmonary disease, sleep apnea syndrome)
  • Patients with preoperative mechanical ventilation
  • Patients with preoperative SpO2 <90%, PaO2 <60 mmHg (FiO2 0.21), or a PaO2/FiO2 ratio <300, or PaCO2 >45 mmHg.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01701908


Contacts
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Contact: Giorgio Della Rocca, Professor +39 0432 559501 giorgio.dellarocca@uniud.it

Locations
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Sponsors and Collaborators
University of Udine
Investigators
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Principal Investigator: Giorgio Della Rocca, Professor University of Udine
Publications:

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Responsible Party: Giorgio Della Rocca, MD, Principal Investigator, University of Udine
ClinicalTrials.gov Identifier: NCT01701908    
Other Study ID Numbers: PPC2012
First Posted: October 5, 2012    Key Record Dates
Last Update Posted: October 8, 2012
Last Verified: October 2012
Keywords provided by Giorgio Della Rocca, University of Udine:
PPCs
abdominal surgery
postoperative infections
postoperative residual curarization
tracheal re-intubation
mortality
ICU stay