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

Withdrawn before enrolling

Conditions studied: Congenital Heart Disease, Single Ventricle

In brief

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).

Key facts

Study ID

NCT02614664

Run by

Roby Sebastian

People needed

0

Starts

2015-11-01

Expected to finish

2017-10-11

Last updated by the study team

2018-08-06

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with single ventricle physiology presenting for laparoscopic procedures.

You may not qualify if…

• None

Where it is running

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

Full record on ClinicalTrials.gov

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