Osteogenesis Imperfecta Blood Pressure Study

Completed

Conditions studied: Osteogenesis Imperfecta

In brief

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.

Key facts

Study ID

NCT04169568

Run by

Nemours Children's Clinic

People needed

50

Starts

2019-11-15

Expected to finish

2025-01-04

Last updated by the study team

2025-05-14

Who can join

Age: 1 and older, up to 35. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patients with OI who are undergoing extremity surgery or spinal fusion surgery.
• Patients between the ages of 1 and 35 years with OI who are admitted at our institution to a non-ICU inpatient setting in the postoperative period following an orthopedic surgery.
• Patients who initially require ICU-level care but transition to a non-ICU setting following an orthopedic surgery.
• Recent fracture in contralateral upper extremity (< 8 weeks, or upper extremity fracture that is not yet completely healed).
• Must be able to tolerate upper extremity blood pressures.
• Medical clearance by OI physicians (Kruse, Franzone) after review of fracture history, surgical procedures, x-rays.

You may not qualify if…

• Parent or child refusal, uncooperative child.
• History of frequent upper extremity fracture on ipsilateral side, or recent upper extremity fracture on ipsilateral side if only that side may be used.
• Clinical presence of thrombocytopenia (excessive or easy bleeding or bruising), admission or transfer to PICU.

Where it is running

• Nemours / A I duPont Hospital for Children — Wilmington, Delaware, United States

Full record on ClinicalTrials.gov

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