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

NCT02614664 | Withdrawn

• 1 other identifier: IRB15-00821
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Congenital Heart Disease; Single Ventricle

Outcome Measures

Primary Outcomes (1)

• 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.)

Study Arms (1)

Single ventricle

Patients with single ventricle physiology presenting for laparoscopic procedures.

Device: NIRS

Interventions

NIRS DEVICE

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

Single ventricle

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with single ventricle anatomy

You may qualify if:

• Patients with single ventricle physiology presenting for laparoscopic procedures.

You may not qualify if:

• None

Sponsors & Collaborators

• Roby Sebastian: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Heart Defects, Congenital; Univentricular Heart

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Roby Sebastian, MD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: November 13, 2015
• First Posted: November 25, 2015
• Study Start: November 1, 2015
• Primary Completion: October 11, 2017
• Study Completion: October 11, 2017
• Last Updated: August 6, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)