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NCT02614664 Clinical Trial

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

Congenital Heart Disease Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02614664
Other study ID # IRB15-00821
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date November 2015
Est. completion date October 11, 2017

Study information
Verified date August 2018
Source Nationwide Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date October 11, 2017
Est. primary completion date October 11, 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- Patients with single ventricle physiology presenting for laparoscopic procedures.

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• NIRS
Cerebral oxygenation monitor which is standard of care for this surgery.

Locations
Country Name City State
United States Nationwide Children's Hospital Columbus Ohio

Sponsors (1)
Lead Sponsor Collaborator
Roby Sebastian

Country where clinical trial is conducted

United States, 

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