Retrospective Review of Anesthetic Considerations for Pulmonary Artery Rehabilitation

June 15, 2017 updated by: Aymen N Naguib
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aymen N Naguib

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

October 23, 2015

First Submitted That Met QC Criteria

October 23, 2015

First Posted (Estimate)

October 26, 2015

Study Record Updates

Last Update Posted (Actual)

June 16, 2017

Last Update Submitted That Met QC Criteria

June 15, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB15-00914

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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