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

NCT02614664 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2018-08-06

No results posted yet for this study

Summary

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).

Conditions

  • Congenital Heart Disease
  • Single Ventricle

Interventions

DEVICE

NIRS

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

Sponsors & Collaborators

  • Roby Sebastian

    lead OTHER

Principal Investigators

  • Roby Sebastian, MD · Nationwide Children's Hospital

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2017-10-11
Completion
2017-10-11

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02614664 on ClinicalTrials.gov