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Expiratory Flow Limitation and Postoperative Complications

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ClinicalTrials.gov Identifier: NCT02229591
Recruitment Status : Completed
First Posted : September 1, 2014
Last Update Posted : October 26, 2016
Sponsor:
Information provided by (Responsible Party):
Savino Spadaro, Università degli Studi di Ferrara

Brief Summary:
Expiratory flow limitation (EFL) occurs when flow ceases to increase with increasing expiratory effort. In any circumstances EFL predisposes to pulmonary dynamic hyperinflation and its unfavorable effects such as increased elastic work of breathing, inspiratory muscles dysfunction, and progressive neuroventilatory dissociation, leading to reduced exercise tolerance, marked breathlessness during effort, and severe chronic dyspnea. Our hypothesis is that EFL should affect post operative outcomes like incidence of pulmonary complication and length of stay in hospital

Condition or disease
Postoperative Respiratory Complications

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Study Type : Observational
Actual Enrollment : 330 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : January 2013
Actual Primary Completion Date : August 2016
Actual Study Completion Date : September 2016

Group/Cohort
EFL patients
Patients with Expiratory Flow Limitation undergoing surgery
Control group
Patients withouth Expiratory Flow Limitation undergoing surgery



Primary Outcome Measures :
  1. Pulmonary complication [ Time Frame: 28 days ]
    Postoperative pulmonary complication such infection, acute respiratory distress, post operative desaturation



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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
Patients undergoing abdominal, thyroid or vascular surgery in Sant'Anna Hospital
Criteria

Inclusion Criteria:

  • General anesthesia
  • Duration of the surgery >2 hours

Exclusion Criteria:

  • <18 years
  • Consensus not given

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): NCT02229591


Locations
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Italy
Azienda Ospedaliero Universitaria Sant'Anna
Ferrara, Italy, 44121
Sponsors and Collaborators
Università degli Studi di Ferrara

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Responsible Party: Savino Spadaro, Universitary Researcher, Università degli Studi di Ferrara
ClinicalTrials.gov Identifier: NCT02229591     History of Changes
Other Study ID Numbers: 17082014
First Posted: September 1, 2014    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016