Detecting Hypotension By Continuous Non-invasive Arterial Pressure Monitoring
- Registration Number
- NCT02532270
- Lead Sponsor
- Fudan University
- Brief Summary
The purpose of this study is to determine whether continuous non-invasive arterial pressure (CNAP) monitoring is beneficial to maintain maternal hemodynamic stability and improve the outcomes of maternal and fetal comparing with intermittent oscillometric non-invasive arterial pressure (NIAP)measurement during spinal anaesthesia for cesarean section .
- Detailed Description
Peri-operative hypotension and fluctuation of arterial blood pressure (BP) during spinal anaesthesia are common. Hypotension causes maternal side-effects such as unconsciousness, dizziness, nausea, and vomiting. The potential fetal side-effects are caused by a reduction in the uterine blood flow with consequent reduced oxygen supply and acidosis reflected by impaired blood gas analyses and impaired Apgar scores. Because of the potential harm to the fetus and the dependency of fetal oxygenation on maternal arterial pressure (AP), it has been strongly recommended to closely monitor mother's arterial pressure and to treat hypotension immediately. Non-invasive arterial pressure (NIAP) measurement is a common method for monitoring in clinical. These hypotension episodes probably would be detected with delay by NIAP measurement on account of its discontinuous. A monitor for continuous non-invasive arterial pressure monitoring (CNAPTM Monitor 500, CNSystems Medizintechnik AG,Graz, Austria) using the volume-clamped method. It can monitor timely and provide beat-to-beat value of arterial pressure.
The purpose of this study is to determine whether continuous non-invasive arterial pressure (CNAP) monitoring is beneficial to maintain maternal hemodynamic stability and improve the outcomes of maternal and fetal.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 100
- scheduled for elective caesarean section with spinal anaesthesia
- pregnancy week above 36
- age<18 yr
- cardiac arrhythmia
- vascular pathologies of the upper limbs (recent vascular surgery, Raynaud's disease， vascular stenosis)
- contraindication for spinal anaesthesia
- emergency case
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group C phenylephrine Arterial pressure of the patients in Group C is measured by continuous non-invasive arterial pressure (CNAP).When systolic blood pressure decreased by over 20% of the basic value or systolic blood pressure lower than 100mmHg after spinal anaesthesia,phenylephrine was administered 50ug .If systolic blood pressure did not improve after 1 minute,phenylephrine was administered repeatedly until systolic blood pressure return to normal. Group N phenylephrine Arterial pressure of the patients in Group N is measured by intermittent oscillometric non-invasive arterial pressure (NIAP).When systolic blood pressure decreased by over 20% of the basic value or systolic blood pressure lower than 100mmHg after spinal anaesthesia,phenylephrine was administered 50ug .If systolic blood pressure did not improve after 1 minute,phenylephrine was administered repeatedly until systolic blood pressure return to normal.
- Primary Outcome Measures
Name Time Method the maximum change of systolic blood pressure(SBP),assessed using continuous non-invasive arterial pressure device or intermittent oscillometric arterial pressure measurement between the spinal anesthetic injection and the delivery of the fetus and placenta,assessed up to 30 mins (baseline SBP-minimum SBP)/baseline SBP
- Secondary Outcome Measures
Name Time Method the incidence of nausea and vomiting on account of hypotension between the spinal anesthetic injection and the delivery of the fetus and placenta,assessed up to 30 mins The presence of nausea and vomiting was measured on a 3-point scale of 1,2, and 3 indicating no nausea and no vomiting, nausea only, and both nausea and vomiting, respectively. Assessments were done at 1-minute intervals after the spinal injection until 25 min.
Detecting the occurrence of hypotension between the spinal anesthetic injection and the delivery of the fetus and placenta,assessed up to 30 mins systolic blood pressure decreased by over 20% of the baseline or systolic blood pressure lower than 100mmHg
the incidence of dizziness on account of hypotension between the spinal anesthetic injection and the delivery of the fetus and placenta,assessed up to 30 mins assessment:yes=patient had dizziness,no=patient had no dizziness
Neonatal outcome was assessed with Apgar scores between the spinal anesthetic injection and the delivery of the fetus and placenta,assessed up to 30 mins umbilical cord blood gases analysis at birth between the spinal anesthetic injection and the delivery of the fetus and placenta,assessed up to 30 mins the incidence of dyspnea on account of hypotension between the spinal anesthetic injection and the delivery of the fetus and placenta,assessed up to 30 mins assessment:yes=patient had dyspnea,no=patient had no dyspnea
Trial Locations
- Locations (1)
Department of Anesthesiology, Department of Obstetrics and Gynecology Hospital, Fudan University
🇨🇳Shanghai, China