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NCT04169568 · ClinicalTrials.gov registry record
Osteogenesis Imperfecta Blood Pressure Study
A clinical trial, sponsored by Nemours Children's Clinic.
- Completed
- Registry status
- 50
- Enrollment target
NCT04169568 is a clinical trial that has completed, run by Nemours Children's Clinic. The registered enrollment target is 50 participants.
The verdict
NCT04169568 has completed, sponsored by Nemours Children's Clinic.
- COMPLETED
- Registry status
- 50 participants
- Enrollment target
Study Summary
Osteogenesis Imperfecta (OI) is a genetic disorder caused by mutations to the alpha-1 or alpha-2 chain of type I collagen. Clinically, the disorder is characterized by bones that fracture easily, often from little or no apparent trauma. There is no information about Some institutions perform blood pressure monitoring on these patients with a cuff, while other institutions avoid this method due to concern for fracture. Instead, they use alternative forms of monitoring such as an arterial line. These methods come with their own risks, including clotting, decreased perfusion, and pain. In addition, arterial lines require intensive (and more expensive) monitoring in a pediatric intensive care unit due to risk of dislodgement and rapid blood loss. These blood pressure monitoring recommendations for patients with OI do not appear to be based on strong evidence. Anecdotally, some patients and healthcare professionals report hearing about individuals with OI who have suffered fractures from blood pressure cuffs. However, this is not well documented in the medical literature. Regular and accurate blood pressure monitoring is particularly important in the postoperative period, due to blood loss and fluid shifts, as well as utilization of advanced pain management techniques that can potentially impact blood pressure.
Interventions
- PROCEDURE Manual cuff blood pressure
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2019-11-15 |
| Est. Completion | 2025-01-04 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04169568
The ClinicalTrials.gov registry entry for NCT04169568 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nemours Children's Clinic, which has 108 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Manual cuff blood pressure is the first listed.
NCT04169568 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04169568 about?
NCT04169568 is a clinical study titled "Osteogenesis Imperfecta Blood Pressure Study". Osteogenesis Imperfecta (OI) is a genetic disorder caused by mutations to the alpha-1 or alpha-2 chain of type I collagen. Clinically, the disorder is characterized by bones that fracture easily, often from little or no apparent trauma. There is no information about Some institutions perform blood p...
What is the current status of trial NCT04169568?
This trial is currently completed. The enrollment target is 50 participants. The study started on 2019-11-15. Estimated completion is 2025-01-04.
What interventions are being tested in trial NCT04169568?
The interventions under investigation include: Manual cuff blood pressure (PROCEDURE).
Who is sponsoring clinical trial NCT04169568?
This trial is sponsored by Nemours Children's Clinic, which has 108 total clinical trials registered on ClinicalTrials.gov.
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