NCT02060825

Brief Summary

This project is evaluating the validity of regional saturation monitoring in evaluating changes in the mesenteric perfusion. Regional saturation monitoring is a standard of care in many institutions, including NCH. Advances in the technology and recent approval of the use of CASMED devices for this purpose will allow us to use this technology more effectively. We aim to evaluate if there is a change in the mesenteric blood flow during the pre, intra and post operative period for the hybrid procedure and the balloon atrial septostomy procedure (BAS).

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

November 1, 2012

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 11, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 12, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

February 1, 2017

Status Verified

January 1, 2017

Enrollment Period

3.8 years

First QC Date

February 11, 2014

Last Update Submit

January 31, 2017

Conditions

Congenital Heart Disease

Outcome Measures

Primary Outcomes (1)

  • Intestinal perfusion

    Immediate post-op period (24 - 96 hours)

Study Arms (1)

Regional saturation monitor

Patients undergoing surgical repair of hypoplastic left heart syndrome.

Device: Regional saturation monitor

Interventions

Regional saturation monitorDEVICE
Also known as: Casmed
Regional saturation monitor

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing surgical repair of hypoplastic left heart syndrome.

You may qualify if:

  • Diagnosis of single ventricle and undergoing the hybrid procedure pathway.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of Pediatric Cardiothoracic Anesthesia

Study Record Dates

First Submitted

February 11, 2014

First Posted

February 12, 2014

Study Start

November 1, 2012

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

February 1, 2017

Record last verified: 2017-01

Locations

US(1)