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NCT02229591 Clinical Trial

Expiratory Flow Limitation and Postoperative Complications

Postoperative Respiratory Complications Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02229591
Other study ID # 17082014
Secondary ID
Status Completed
Phase N/A
First received August 28, 2014
Last updated October 25, 2016
Start date January 2013
Est. completion date September 2016

Study information
Verified date October 2016
Source Università degli Studi di Ferrara
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 330
Est. completion date September 2016
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- General anesthesia

- Duration of the surgery >2 hours

Exclusion Criteria:

- <18 years

- Consensus not given

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Italy Azienda Ospedaliero Universitaria Sant'Anna Ferrara

Sponsors (1)
Lead Sponsor Collaborator
Università degli Studi di Ferrara

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pulmonary complication Postoperative pulmonary complication such infection, acute respiratory distress, post operative desaturation 28 days No
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