Can Point of Care Chest Ultrasound Predicts Pulmonary Com... | NCT02979652

Studies
Can Point of Care Chest Ultrasound Predicts Pulmonary Complications After Major Surgery?

NCT02979652

Sponsor

Hospital Nord

Status

Unknown status

Last Update Posted

Dec 1, 2016Estimated

Enrollment

325Estimated

Phase

Not provided

Conditions

Intensive Care, Surgical

Interventions

Not provided

Countries

France

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

Nov 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2016

Primary Completion Date

Nov 2017Estimated

Completion Date

Jan 2018Estimated

First Submitted Date

Nov 24, 2016

First Submission Date that Met QC Criteria

Nov 30, 2016

First Posted Date

Dec 1, 2016Estimated

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

Nov 30, 2016

Last Update Posted Date

Dec 1, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

This study is done to estimate prevalence of the main detectable lung and cardiovascular complications by an ultrasound realized in room of post-interventional supervision at the patients whose duration of general anesthesia is superior at one hour after a surgery to risk

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

Yes

Target Follow-Up Duration

8 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

325Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
cardiac and pulmonary functions	cardiac and pulmonary functions will be evaluated by cardiac and pulmonary ultrasound exams for all patient whom have a more than 1 hour surgical intervention	1 hour

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Physical status score > 1
Anesthesia of duration > 1 hour
Visceral, orthopaedic, vascular, thoracic surgery, neurosurgery

Exclusion Criteria:

Technical incapacity of accessibility to the ultrasound window
Cardiac or pulmonary transplant

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 hospatilized for a major surgery

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marc Leone, M.D	Contact			mleone@ap-hm.fr

Overall Officials

Name	Affiliation	Role
Marc Leone, MD	Departement anesthesie reanimation hopital nord	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Departement anesthesie reanimation hopital nord	Recruiting	Marseille		13015	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided