View clinical trials related to Non-Invasive Blood Pressure.
Filter by:Intra-operative hypotension is linked to increased postoperative morbidity and mortality. Intra-operative MAP below 60-70 mmHg or SBP below 100 mmHg increase the risk of post operative myocardial injury, acute kidney injury and death. accurate measurement of blood pressure is fundamental in proper mangement of intraperative hypotension. Measurement of arterial blood pressure through an arterial catheter is restricted to patients with major, rapid changes in blood pressure in the operating room as well as the intensive care units. Among non-invasive blood pressure (NIBP) monitors, oscillometric blood pressure measuring technology is considered the standard and the most widely used method in medical practice. In oscillometric blood pressure monitor, a pressure transducer located in the cuff senses the maximal arterial oscillation, which represents the mean arterial pressure, and according to the device's algorithm the systolic and diastolic blood pressure (SBP and DBP) will be calculated. The upper arm is the standard location of application of the blood pressure cuff as it is aligned with the heart level regardless the patient position. Many surgical procedures, sometimes major, are conducted in the lateral position; during these operations, the choice of the side for application of the NIBP cuff is a challenging decision with no clear recommendations. The non-dependent upper limb is claimed to be inaccurate measurement site because the cuff position is above the level of the heart. While, the dependent upper limb might be affected by compression of the axilla and the upper arm. No data, to the best of our knowledge are available for the accuracy of NIBP in both upper limbs in the lateral position using the invasive arterial blood pressure (IBP) as a reference for detecting intraoperative hypotension.
Spinal anesthesia-induced maternal hypotension during cesarean delivery is hazardous to the mother and the fetus. Prevention of the unfavorable outcomes of maternal hypotension includes various fluid and vasopressor protocols, and requires careful, frequent monitoring of blood pressure during the first 30 minutes after spinal block. Many clinicians set the blood pressure measurement intervals at 1- minute or 2-minutes intervals during the early period after spinal block. it had been reported that hypotension of duration less than 2 minutes is not harmful to the neonate; thus, the minimum inter-measurement intervals for blood pressure readings should be 2 minutes. This high frequency of blood pressure measurements commonly leads to patient dis-satisfaction due to pain as well as impairment of the interaction with the fetus after delivery. Moreover, the blood pressure measurement in the upper limbs could be affected by movement and shivering. Using the ankle for measurement of non-invasive blood pressure (NIBP) was previously evaluated in normal subjects, and was reported to be feasible; however, its normal range differed from the arm NIBP. Under spinal anesthesia, the lower limb of the mother is neither mobile, nor sensate. Thus, it was previously hypothesized that measurement of blood pressure at the ankle of the mother could improve patient comfort. Darke and Hill had evaluated the accuracy of non-invasive blood pressure at the arm and the ankle during cesarean delivery. Darke and Hill had reported that the degree of bias between the two sites is not acceptable; however, their study did not evaluate the accuracy of ankle NIBP as a trend monitor to trace the changes in maternal blood pressure. The aim of this work is to evaluate the accuracy and precision of ankle NIBP as a trend monitor in mothers undergoing cesarean delivery under spinal anesthesia.
This study is being conducted to validate the accuracy of non-invasive blood pressure (NIBP) measurement technology from Mortara Instrument, Inc. (Milwaukee, Wisconsin, USA) and Zoe Medical, Inc. (Topsfield, Massachusetts, USA) in a neonatal, infants and children up to 3 years old patient population. The study is defined according to the International Standard "ANSI/AAMI/ISO 81060-2:2013, Non-invasive sphygmomanometers — Part 2: Clinical investigation of automated measurement type".
This investigation is a multi-center study that will demonstrate that the GE Monitor meets equivalency and/or accuracy and/or performance criteria. This investigation will compare the test device(s) to itself, or one of the reference parameters, or a combination of parameters, including NIBP, temperature, SpO2, respirations, and ECG.
The accuracy and/or performance of the GE DINAMAP noninvasive blood pressure (NIBP) monitors may be improved with modifications in software and/or hardware monitoring techniques and/or accessories. When changes are being made to the GE Monitor, testing can be done to evaluate performance of the investigational devices during and/or after product development.