Wrist NIBP During Elective Cesarean Delivery
|ClinicalTrials.gov Identifier: NCT01677234|
Recruitment Status : Completed
First Posted : August 31, 2012
Last Update Posted : July 3, 2013
|Condition or disease|
|Wrist Blood Pressure Measurements Anesthesia Resulting in Shivering|
Upper arm non-invasive blood pressure (NIBP) measurement is the most commonly accepted method of blood pressure (BP) monitoring. During a cesarean delivery it may be challenging to obtain an accurate measurement from the automated devices in over 50% of the attempts due to arm movement.1 Patients may voluntarily move their arm, but more often neuraxial (spinal, epidural, combined spinal-epidural) anesthesia is known to induce shivering that causes the patient's arm to shake.2 To eliminate the effect of movement of the upper arm, NIBP has been tested on the leg because it is immobilized during neuraxial anesthesia. However, studies monitoring NIBP on an ankle or a calf were unable to accurately detect changes (increase or decrease) in blood pressure in patients undergoing a cesarean delivery.3,4 It seems clinically reasonable that in the case of a shivering patient, the forearm, with less muscle mass, would shake less and could be stabilized more easily than the upper arm (stabilizing the forearm is easily done by holding the patient's hand with a light pressure on the arm rest). Therefore, positioning an NIBP cuff on the forearm (near the wrist) may be useful to obtain an accurate blood pressure measurement in shivering patients.
Previous studies have found that forearm BP overestimates blood pressure measured at the upper arm in a variety of clinical settings and patient populations under static (patient at rest, not submitted to an intervention that might alter BP) circumstances.5-8 It is unknown whether this overestimation is clinically relevant when blood pressure change occurs rapidly, such as during a cesarean delivery. During neuraxial anesthesia for cesarean delivery, it is important for the anesthesiologist to know both absolute values and clinically significant changes in blood pressure to determine their treatment. The detection of dynamic changes in blood pressure (as when the patient is submitted to an intervention that might alter BP per se, e.g. neuraxial anesthesia) has been studied in obstetric patients. Nevertheless, either due to the location where the BP cuff was placed4 (as on the lower limb with interference of the aorto-caval compression) or to the technology used to measure blood pressure,9 (the penaz technology was not consistent with oscillometric technology in a previous study) the forearm blood pressure was not comparable to upper arm blood pressure when measured using an oscillometric monitor.
This study will compare the upper arm (the current gold-standard) and the forearm NIBP measurements in patients undergoing an elective cesarean delivery under subarachnoid anesthesia. We hypothesize that the forearm systolic BP measurement values will be within 10% (lower or higher) of the systolic BP values measured in the upper arm at the same time-points
|Study Type :||Observational|
|Actual Enrollment :||71 participants|
|Official Title:||Comparison of Arm and Forearm Blood Pressure During Elective Cesarean Delivery|
|Study Start Date :||August 2012|
|Primary Completion Date :||May 2013|
|Study Completion Date :||May 2013|
Pregnant women undergoing a cesarean section
- Compare trends in NIBP measurements between the upper arm and forearm [ Time Frame: 30 minutes ]Measure NIBP at the upper arm and forearm simultaneously during surgery. NIBP cuffs will be on opposite arms.
- To estimate the accuracy of blood pressure measured on the forearm [ Time Frame: 30 minutes ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01677234
|Canada, British Columbia|
|British Columbia's Women's Hospital|
|Vancouver, British Columbia, Canada, V6H 3N1|
|Principal Investigator:||Simon Massey, MD||University of British Columbia, BC Women's Hospital|