Retrospective Review of Anesthetic Considerations for Pul... | NCT02586740

Studies
Retrospective Review of Anesthetic Considerations for Pulmonary Artery Rehabilitation

NCT02586740

Sponsor

Aymen N Naguib

Status

Completed

Last Update Posted

Jun 16, 2017Actual

Enrollment

120Actual

Phase

Not provided

Conditions

Pulmonary Artery Stenosis
Tetralogy of Fallot
Pulmonary Atresia

Interventions

Pulmonary artery rehabilitation

Countries

United States

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

Jun 2017

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

Nov 2015

Primary Completion Date

Oct 2016Actual

Completion Date

Oct 2016Actual

First Submitted Date

Oct 23, 2015

First Submission Date that Met QC Criteria

Oct 23, 2015

First Posted Date

Oct 26, 2015Estimated

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

Jun 15, 2017

Last Update Posted Date

Jun 16, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Aymen N Naguib, Director of Pediatric Cardiothoracic Anesthesia, Nationwide Children's HospitalSponsor-Investigator

Lead Sponsor

Aymen N NaguibOTHER

Collaborators

Not provided

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

Pulmonary artery rehabilitation procedure is done frequently in the catheterization suite for patients with pulmonary artery stenosis or small pulmonary arteries following surgical repair for patients with tetralogy of Fallot with pulmonary atresia and major aortopulmonary collaterals. Considering that the investigators' institution is a major center for treating these cases, the investigators wanted to do a retrospective review of the investigators' data to share the investigators' anesthetic management of these procedures.

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

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pulmonary artery rehabilitation		Patients with pulmonary artery stenosis or small pulmonary arteries following surgical repair for tetralogy of Fallot with pulmonary atresia and major aortopulmonary collaterals undergoing cardiac catheterization.	Procedure: Pulmonary artery rehabilitation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pulmonary artery rehabilitation	Procedure		Pulmonary artery rehabilitation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients who experience hemorrhage		During catheterization procedure.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who underwent pulmonary artery angioplasty during the period between October 1st 2010 and October 1st 2015 at NCH.

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with pulmonary artery stenosis or small pulmonary arteries following surgical repair for tetralogy of Fallot with pulmonary atresia and major aortopulmonary collaterals.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nationwide Children's Hospital		Columbus	Ohio	43205	United States

Condition Browse Module

MeSH Terms

ID	Term
D000071079	Stenosis, Pulmonary Artery
D013771	Tetralogy of Fallot
D018633	Pulmonary Atresia

Ancestor Terms

ID	Term
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D006330	Heart Defects, Congenital

Browse Leaves

Not provided

Browse Branches

Not provided