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NCT02157597 · ClinicalTrials.gov registry record · NA
NIRS Guidance Trail in Children's Heart Surgery
A NA study, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- NA
- Development phase
- 73
- Enrollment target
NCT02157597: Completed NA study, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT02157597 is a NA study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 73 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02157597, a NA study, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- NA
- Development phase
- 73 participants
- Enrollment target
Study Summary
Heart surgery in young children involves some risks. This study looks at a new type of monitor that may reduce these risks. Near Infrared Reflectance Spectroscopy (NIRS) aims to measure if enough blood reaches vital organs in the body. The investigators goal is to see if this shows problems developing sooner than usual. The investigators do not know at this time if they can improve the blood supply to the vital organs. The investigators main aim is to see which responses work the best. The NIRS monitor is approved by the U.S. Food and Drug Administration (FDA). The investigators will also follow the progress of recovery after surgery in the Cardiac Intensive Care Unit (CICU). This will find out if using the NIRS monitor improves the outcome for children.
Primary Outcome
The investigators will assess effects of NIRS guidance in two ways. The primary outcome measure is the cumulative time (AUC) that rScO2 is below threshold (from continuous electronic recording of NIRS data). rScO2 will be taken as the mean of left and right forehead sensor readings. AUC will be calculated before and after CPB in the OR and during the first 24 hours postop in the CICU, and summed. Initial analyses of primary outcome to compare treatment groups will be undertaken on an intention-t
Interventions
- OTHER Control
- OTHER NIRS based management
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2011-11 |
| Est. Completion | 2016-01 |
| Phase | NA |
What the finished NCT02157597 record still lists
NCT02157597 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Control is the first listed.
NCT02157597 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02157597 about?
NCT02157597 is a clinical study titled "NIRS Guidance Trail in Children's Heart Surgery". Heart surgery in young children involves some risks. This study looks at a new type of monitor that may reduce these risks. Near Infrared Reflectance Spectroscopy (NIRS) aims to measure if enough blood reaches vital organs in the body. The investigators goal is to see if this shows problems developi...
What is the current status of trial NCT02157597?
This trial is currently completed. It is a NA study. The enrollment target is 73 participants. The study started on 2011-11. Estimated completion is 2016-01.
What interventions are being tested in trial NCT02157597?
The interventions under investigation include: Control (OTHER), NIRS based management (OTHER).
Who is sponsoring clinical trial NCT02157597?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02157597's enrollment target sits among peer trials
73 1089th of 2000 higher than 912 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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