Congenital Heart DiseaseNCT02614664
Changes in Cerebral Oxygenation During Laparoscopy in Patients With Single Ventricle Anatomy
An observational study of Congenital Heart Disease and Single Ventricle, run by Roby Sebastian at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Congenital Heart Disease, Single Ventricle
- What is being tested?
- NIRS
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to 11 Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with single ventricle anatomy
Who may be able to join
- Patients with single ventricle physiology presenting for laparoscopic procedures.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
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
- Being tested
- NIRS
- Medical subject headings
- Heart Defects, Congenital, Univentricular Heart
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIRSDevice
Cerebral oxygenation monitor which is standard of care for this surgery.
| Study group | Role | What they receive |
|---|---|---|
| Single ventricle | Patients with single ventricle physiology presenting for laparoscopic procedures. Receives: Device: NIRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cerebral oxygenation values
Measured on the NIRS cerebral oxygenation monitor attached to the patient.
Measured: From baseline to insufflation (average time frame of 30 mins. - 2 hrs.)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2015 (estimated)
- Study startNov 2015 (estimated)
- Primary completion11 Oct 2017
- Study completion11 Oct 2017
Why it stopped: Principal Investigator moved to another institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roby Sebastian
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Roby Sebastian, Nationwide Children's Hospital
- Investigators
- Roby Sebastian, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02614664
- Sponsor's protocol ID
- IRB15-00821
- Status last verified
- Aug 2018
- First submitted
- 13 Nov 2015
- Last updated
- 6 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Cerebral Oxygenation During Laparoscopy in Patients With Single Ventricle Anatomy
- ClinicalTrials.gov ID
- NCT02614664
- Acronym / sponsor ID
- IRB15-00821
- Conditions
- Congenital Heart Disease, Single Ventricle
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Principal Investigator moved to another institution.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Roby SebastianUniversity, hospital or other
- Study start
- Nov 2015 (estimated)
- Primary completion
- 11 Oct 2017 (actual)
- Study completion
- 11 Oct 2017 (actual)
- First posted
- 25 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single ventricle | – | Device: NIRSPatients with single ventricle physiology presenting for laparoscopic procedures. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with single ventricle anatomy
Key inclusion criteria (1 listed)
- Patients with single ventricle physiology presenting for laparoscopic procedures.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NIRSCerebral oxygenation monitor which is standard of care for this surgery. | Device | Single ventricle |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2018.
- Individual participant dataSharing planned: No
Related trials for Congenital Heart Disease
RecruitingPhase 1/2
Butyric Acid Supplementation for Gut Improvement After Cardiac Surgery in Kids
Congenital Heart Disease (CHD)
Not yet recruiting
Starry-Sky Projection and Maternal Voice for Sleep After Pediatric Cardiac Surgery
Congenital Heart Disease (CHD), Postoperative Sleep
Enrolling by invitation
EXCOR Active Driving System for the EXCOR Pediatric VAD IDE Study
Heart Failure, Transplant; Failure, Heart
Recruiting
Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study
Congenital Heart Disease, Congenital Heart Disease (CHD)
RecruitingPhase 4
Sodium-Glucose Cotransporter 2 Inhibitors for Repaired Tetralogy of Fallot Patients for Enhancement of Cardio-Pulmonary Status Trial
Congenital Heart Disease, Repaired Tetralogy of Fallot (rTOF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roby Sebastian, MD principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease and Single Ventricle, run by Roby Sebastian at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cerebral oxygenation values (time frame: From baseline to insufflation (average time frame of 30 mins. - 2 hrs.)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2018; AzTrials last refreshed its copy on 1 Nov 2026.