MedTrace Logo

Osteogenesis Imperfecta Blood Pressure Study

NCT04169568 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2025-05-14

No results posted yet for this 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.

Conditions

Interventions

PROCEDURE

Manual cuff blood pressure

Blood pressure will be obtained using a sphygmomanometer. Only Registered Nurses will apply BP cuff after careful inspection of the upper extremity for bruising, swelling or tenderness.

Sponsors & Collaborators

  • Nemours Children's Clinic

    lead OTHER

Principal Investigators

  • Alicia McCarthy, MSN · Nemours Children's Hospital

Eligibility

Min Age
1 Year
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-15
Primary Completion
2025-01-04
Completion
2025-01-04

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04169568 on ClinicalTrials.gov