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

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02614664

Enrollment

Registered

2015-11-25

Start date

2015-11-30

Completion date

2017-10-11

Last updated

2018-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Heart Disease, Single Ventricle

Brief 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).

Interventions

DEVICENIRS

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Patients with single ventricle physiology presenting for laparoscopic procedures.

Exclusion criteria

* None

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026