Congenital Heart DiseaseNCT02060825
The Use of Optical Oximetry in Determining Gastrointestinal Complications After the Hybrid Procedure
An observational study of Congenital Heart Disease, run by Aymen N Naguib at 1 site in United States.
Trial summary
This project is evaluating the validity of regional saturation monitoring in evaluating changes in the mesenteric perfusion. Regional saturation monitoring is a standard of care in many institutions, including NCH. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Regional saturation monitor
- Type of treatment
- Medical device
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Sep 2016
- 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 undergoing surgical repair of hypoplastic left heart syndrome.
Who may be able to join
- Diagnosis of single ventricle and undergoing the hybrid procedure pathway.
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
This project is evaluating the validity of regional saturation monitoring in evaluating changes in the mesenteric perfusion. Regional saturation monitoring is a standard of care in many institutions, including NCH. Advances in the technology and recent approval of the use of CASMED devices for this purpose will allow us to use this technology more effectively. We aim to evaluate if there is a change in the mesenteric blood flow during the pre, intra and post operative period for the hybrid procedure and the balloon atrial septostomy procedure (BAS).
- Conditions
- Congenital Heart Disease
- Being tested
- Regional saturation monitor
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regional saturation monitorDevice
Also called Casmed
| Study group | Role | What they receive |
|---|---|---|
| Regional saturation monitor | Patients undergoing surgical repair of hypoplastic left heart syndrome. Receives: Device: Regional saturation monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intestinal perfusion
Measured: Immediate post-op period (24 - 96 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2014 (estimated)
- Study startNov 2012
- Primary completionSep 2016
- Study completionSep 2016
Why it stopped: Difficulty in downloading and saving data from the oximetry machine.
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
- Case only
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aymen N Naguib
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aymen N Naguib, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02060825
- Sponsor's protocol ID
- IRB12-00687
- Status last verified
- Jan 2017
- First submitted
- 11 Feb 2014
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Optical Oximetry in Determining Gastrointestinal Complications After the Hybrid Procedure
- ClinicalTrials.gov ID
- NCT02060825
- Acronym / sponsor ID
- IRB12-00687
- Conditions
- Congenital Heart Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Difficulty in downloading and saving data from the oximetry machine.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Aymen N NaguibUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 12 Feb 2014 (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.
This project is evaluating the validity of regional saturation monitoring in evaluating changes in the mesenteric perfusion. Regional saturation monitoring is a standard of care in many institutions, including NCH. Advances in the technology and recent approval of the use of CASMED devices for this purpose will allow us to use this technology more effectively. We aim to evaluate if there is a change in the mesenteric blood flow during the pre, intra and post operative period for the hybrid procedure and the balloon atrial septostomy procedure (BAS).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Regional saturation monitor | – | Device: Regional saturation monitorPatients undergoing surgical repair of hypoplastic left heart syndrome. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing surgical repair of hypoplastic left heart syndrome.
Key inclusion criteria (1 listed)
- Diagnosis of single ventricle and undergoing the hybrid procedure pathway.
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 |
|---|---|---|
| Regional saturation monitorAlso: Casmed | Device | Regional saturation monitor |
Primary outcome
Intestinal perfusion
Time frame: Immediate post-op period (24 - 96 hours)
Results and safety
The study was stopped early (reason given: Difficulty in downloading and saving data from the oximetry machine.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Aymen N Naguib 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: stopped early, as of the sponsor's last update on 1 Feb 2017. 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 stopped early (reason given: Difficulty in downloading and saving data from the oximetry machine.). Results are not available in the source record.
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?
Intestinal perfusion (time frame: Immediate post-op period (24 - 96 hours)). 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 1 Feb 2017.