Clinical trial NCT02532270: Detecting Hypotension By Continuous Non-invasive Arterial Pressure Monitoring
Official title: Detecting Hypotension By Continuous Non-invasive Arterial Pressure Monitoring During Spinal Anaesthesia for Cesarean Section:A Prospective,Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypotension
Keywords: obstetric
anesthesia
hypotension
arterial pressure
measurement techniques
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2015-08-25
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* scheduled for elective caesarean section with spinal anaesthesia
* pregnancy week above 36

Exclusion Criteria:

* 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

Primary outcomes:
measure: the maximum change of systolic blood pressure(SBP),assessed using continuous non-invasive arterial pressure device or intermittent oscillometric arterial pressure measurement
timeFrame: between the spinal anesthetic injection and the delivery of the fetus and placenta,assessed up to 30 mins
Secondary outcomes:
measure: Detecting the occurrence of hypotension
timeFrame: between the spinal anesthetic injection and the delivery of the fetus and placenta,assessed up to 30 mins
measure: Neonatal outcome was assessed with Apgar scores
timeFrame: between the spinal anesthetic injection and the delivery of the fetus and placenta,assessed up to 30 mins
measure: umbilical cord blood gases analysis at birth
timeFrame: between the spinal anesthetic injection and the delivery of the fetus and placenta,assessed up to 30 mins
measure: the incidence of nausea and vomiting on account of hypotension
timeFrame: between the spinal anesthetic injection and the delivery of the fetus and placenta,assessed up to 30 mins
measure: the incidence of dizziness on account of hypotension
timeFrame: between the spinal anesthetic injection and the delivery of the fetus and placenta,assessed up to 30 mins
measure: the incidence of dyspnea on account of hypotension
timeFrame: between the spinal anesthetic injection and the delivery of the fetus and placenta,assessed up to 30 mins
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Anesthesiology, Department of Obstetrics and Gynecology Hospital, Fudan University
Study officials:
affiliation: Department of Anesthesiology, Department of Obstetrics and Gynecology Hospital, Fudan University
name: Shaoqiang Huang, Dr
role: STUDY_DIRECTOR
References:
citation: Ilies C, Kiskalt H, Siedenhans D, Meybohm P, Steinfath M, Bein B, Hanss R. Detection of hypotension during Caesarean section with continuous non-invasive arterial pressure device or intermittent oscillometric arterial pressure measurement. Br J Anaesth. 2012 Sep;109(3):413-9. doi: 10.1093/bja/aes224. Epub 2012 Jul 12.
citation: Jeleazcov C, Krajinovic L, Munster T, Birkholz T, Fried R, Schuttler J, Fechner J. Precision and accuracy of a new device (CNAPTM) for continuous non-invasive arterial pressure monitoring: assessment during general anaesthesia. Br J Anaesth. 2010 Sep;105(3):264-72. doi: 10.1093/bja/aeq143. Epub 2010 Jul 13.
citation: Banerjee A, Stocche RM, Angle P, Halpern SH. Preload or coload for spinal anesthesia for elective Cesarean delivery: a meta-analysis. Can J Anaesth. 2010 Jan;57(1):24-31. doi: 10.1007/s12630-009-9206-7. Epub 2009 Oct 27.
citation: Lee A, Ngan Kee WD, Gin T. A quantitative, systematic review of randomized controlled trials of ephedrine versus phenylephrine for the management of hypotension during spinal anesthesia for cesarean delivery. Anesth Analg. 2002 Apr;94(4):920-6, table of contents. doi: 10.1097/00000539-200204000-00028.
citation: Maayan-Metzger A, Schushan-Eisen I, Todris L, Etchin A, Kuint J. Maternal hypotension during elective cesarean section and short-term neonatal outcome. Am J Obstet Gynecol. 2010 Jan;202(1):56.e1-5. doi: 10.1016/j.ajog.2009.07.012. Epub 2009 Aug 28.