- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02614664
Changes in Cerebral Oxygenation During Laparoscopy in Patients With Single Ventricle Anatomy
August 2, 2018 updated by: Roby Sebastian
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).
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43205
- Nationwide Children's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with single ventricle anatomy
Description
Inclusion Criteria:
- Patients with single ventricle physiology presenting for laparoscopic procedures.
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Single ventricle
Patients with single ventricle physiology presenting for laparoscopic procedures.
|
Cerebral oxygenation monitor which is standard of care for this surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in cerebral oxygenation values
Time Frame: From baseline to insufflation (average time frame of 30 mins. - 2 hrs.)
|
Measured on the NIRS cerebral oxygenation monitor attached to the patient.
|
From baseline to insufflation (average time frame of 30 mins. - 2 hrs.)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Roby Sebastian, MD, Nationwide Children's Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
November 1, 2015
Primary Completion (Actual)
October 11, 2017
Study Completion (Actual)
October 11, 2017
Study Registration Dates
First Submitted
November 13, 2015
First Submitted That Met QC Criteria
November 23, 2015
First Posted (Estimate)
November 25, 2015
Study Record Updates
Last Update Posted (Actual)
August 6, 2018
Last Update Submitted That Met QC Criteria
August 2, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB15-00821
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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