Clinical Trial Details
— Status: Suspended
Administrative data
NCT number |
NCT04169568 |
Other study ID # |
1465218-3 |
Secondary ID |
|
Status |
Suspended |
Phase |
|
First received |
|
Last updated |
|
Start date |
November 15, 2019 |
Est. completion date |
July 15, 2024 |
Study information
Verified date |
July 2023 |
Source |
Nemours Children's Clinic |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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.
Description:
Introduction Osteogenesis Imperfecta (OI) is a genetic disorder caused by mutations to the
alpha-1 or alpha-2 chain of type I collagen. There are eight forms of OI, ranging from type I
through VIII, however in types V to VIII the symptoms and severity fall within the range of
the first four types. Clinically, the disorder is characterized by bones that fracture
easily, often from little or no apparent trauma. These patients require special care and
handling to minimize risk of fracture, and often undergo multiple surgeries to stabilize
fractures and prevent or correct bone deformities. However, specific guidelines and
restrictions for care, including clinical and postoperative care, vary between patients and
among institutions. Some institutions perform blood pressure monitoring with a
circumferential cuff, while other institutions avoid this method due to concern for
iatrogenic fracture. Instead, they utilize alternative forms of monitoring such as an
arterial line. Currently at Nemours, children and adults with OI have arterial lines placed
in the OR for the purpose of BP monitoring. These more invasive methods come with their own
risks, including thrombosis, 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 supported in the 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.
Aim of the study: In this observational study, we intend to evaluate the feasibility of
non-invasive cuff blood pressure monitoring in a select group of patients with OI in the
inpatient postoperative period.
Materials and Methods Following Nemours IRB approval and consent from the parent or legal
guardian, fifty children with OI scheduled for lower extremity surgery with subsequent
in-hospital admission will be enrolled in the study. Since we performed preformed lower
extremity surgeries on thirty patients in each of the past two years, we anticipate the study
will take two years to complete.
A group of registered nurses would be educated about the study and equipment used, review of
appropriate blood pressure cuff size selection, blood pressure monitoring protocol, signs and
symptoms of adverse events, and steps to take if an adverse event occurred.
Inclusion Criteria:
- Patients of all ages with OI who are admitted at our institution to the inpatient,
non-ICU setting, in the postoperative period following an orthopedic surgery.
- 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.
Exclusion Criteria:
- Parent or child refusal, uncooperative child.
- History of frequent upper extremity fracture, recent upper extremity fracture (< 8
weeks, or upper extremity fracture that is not yet completely healed).
- Thrombocytopenia, admission or transfer to PICU.