Changes in Cerebral Oxygenation During Laparoscopy in Patients With Single Ventricle Anatomy

August 2, 2018 updated by: Roby Sebastian
Patients with single ventricle physiology (hypoplastic left heart syndrome, tricuspid atresia) frequently have feeding difficulties necessitating procedures such as Nissen fundoplication and G-tube placement. With advances in minimally invasive surgery, these are frequently performed using laparoscopic techniques. Although generally safe and effective, the increase in IAP during laparoscopy may increase systemic and pulmonary vascular resistance and decrease cardiac output. This prospective study will include 50 patients with single ventricle physiology presenting for laparoscopic procedures. There will be no change in the anesthetic or perioperative care of these patients. Tissue and cerebral oxygenation will be monitored using near infrared spectroscopy (NIRS).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with single ventricle anatomy

Description

Inclusion Criteria:

  • Patients with single ventricle physiology presenting for laparoscopic procedures.

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
Single ventricle
Patients with single ventricle physiology presenting for laparoscopic procedures.
Device: NIRS
Cerebral oxygenation monitor which is standard of care for this surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in cerebral oxygenation values
Time Frame: From baseline to insufflation (average time frame of 30 mins. - 2 hrs.)
Measured on the NIRS cerebral oxygenation monitor attached to the patient.
From baseline to insufflation (average time frame of 30 mins. - 2 hrs.)

Collaborators and Investigators

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

Sponsor

Roby Sebastian

Investigators

  • Principal Investigator: Roby Sebastian, MD, Nationwide Children's Hospital

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 (Anticipated)

November 1, 2015

Primary Completion (Actual)

October 11, 2017

Study Completion (Actual)

October 11, 2017

Study Registration Dates

First Submitted

November 13, 2015

First Submitted That Met QC Criteria

November 23, 2015

First Posted (Estimate)

November 25, 2015

Study Record Updates

Last Update Posted (Actual)

August 6, 2018

Last Update Submitted That Met QC Criteria

August 2, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB15-00821

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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