NCT02614664

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

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Roby Sebastian · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Type	Name	Description
DEVICE	NIRS	Cerebral oxygenation monitor which is standard of care for this surgery.

Timeline

• Start date: 2015-11-01
• Primary completion: 2017-10-11
• Completion: 2017-10-11
• First posted: 2015-11-25
• Last updated: 2018-08-06

Locations

1 site across 1 country: United States