Expiratory Flow Limitation and Postoperative Complications | NCT02229591

Studies
Expiratory Flow Limitation and Postoperative Complications

NCT02229591

Sponsor

Università degli Studi di Ferrara

Status

Completed

Last Update Posted

Oct 26, 2016Estimated

Enrollment

330Actual

Phase

Not provided

Conditions

Postoperative Respiratory Complications

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2013

Primary Completion Date

Aug 2016Actual

Completion Date

Sep 2016Actual

First Submitted Date

Aug 28, 2014

First Submission Date that Met QC Criteria

Aug 28, 2014

First Posted Date

Sep 1, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 25, 2016

Last Update Posted Date

Oct 26, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Savino Spadaro, Universitary Researcher, Università degli Studi di FerraraPrincipal Investigator

Lead Sponsor

Università degli Studi di FerraraOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

330Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EFL patients		Patients with Expiratory Flow Limitation undergoing surgery
Control group		Patients withouth Expiratory Flow Limitation undergoing surgery

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pulmonary complication	Postoperative pulmonary complication such infection, acute respiratory distress, post operative desaturation	28 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

General anesthesia
Duration of the surgery >2 hours

Exclusion Criteria:

<18 years
Consensus not given

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Azienda Ospedaliero Universitaria Sant'Anna		Ferrara		44121	Italy