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

NCT ID: NCT02614664

Last Updated: 2018-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-10-11

Brief Summary

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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).

Detailed Description

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Conditions

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Congenital Heart Disease Single Ventricle

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Single ventricle

Patients with single ventricle physiology presenting for laparoscopic procedures.

NIRS

Intervention Type DEVICE

Cerebral oxygenation monitor which is standard of care for this surgery.

Interventions

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NIRS

Cerebral oxygenation monitor which is standard of care for this surgery.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients with single ventricle physiology presenting for laparoscopic procedures.

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Roby Sebastian

OTHER

Sponsor Role lead

Responsible Party

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Roby Sebastian

Clinical Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Roby Sebastian, MD

Role: PRINCIPAL_INVESTIGATOR

Nationwide Children's Hospital

Locations

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Nationwide Children's Hospital

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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IRB15-00821

Identifier Type: -

Identifier Source: org_study_id

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