NCT02229591

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
330

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 28, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 1, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

October 26, 2016

Status Verified

October 1, 2016

Enrollment Period

3.6 years

First QC Date

August 28, 2014

Last Update Submit

October 25, 2016

Conditions

Postoperative Respiratory Complications

Outcome Measures

Primary Outcomes (1)

  • Pulmonary complication

    Postoperative pulmonary complication such infection, acute respiratory distress, post operative desaturation

    28 days

Study Arms (2)

EFL patients

Patients with Expiratory Flow Limitation undergoing surgery

Control group

Patients withouth Expiratory Flow Limitation undergoing surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • General anesthesia
  • Duration of the surgery \>2 hours

You may not qualify if:

  • \<18 years
  • Consensus not given

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Azienda Ospedaliero Universitaria Sant'Anna

Ferrara, 44121, Italy

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Universitary Researcher

Study Record Dates

First Submitted

August 28, 2014

First Posted

September 1, 2014

Study Start

January 1, 2013

Primary Completion

August 1, 2016

Study Completion

September 1, 2016

Last Updated

October 26, 2016

Record last verified: 2016-10

Locations

IT(1)