- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02229591
Expiratory Flow Limitation and Postoperative Complications
October 25, 2016 updated by: Savino Spadaro, Università degli Studi di Ferrara
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
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
330
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Ferrara, Italy, 44121
- Azienda Ospedaliero Universitaria Sant'Anna
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients undergoing abdominal, thyroid or vascular surgery in Sant'Anna Hospital
Description
Inclusion Criteria:
- General anesthesia
- Duration of the surgery >2 hours
Exclusion Criteria:
- <18 years
- Consensus not given
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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EFL patients
Patients with Expiratory Flow Limitation undergoing surgery
|
Control group
Patients withouth Expiratory Flow Limitation undergoing surgery
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pulmonary complication
Time Frame: 28 days
|
Postoperative pulmonary complication such infection, acute respiratory distress, post operative desaturation
|
28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
August 1, 2016
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
August 28, 2014
First Submitted That Met QC Criteria
August 28, 2014
First Posted (Estimate)
September 1, 2014
Study Record Updates
Last Update Posted (Estimate)
October 26, 2016
Last Update Submitted That Met QC Criteria
October 25, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- 17082014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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