Detecting Hypotension By Continuous Non-invasive Arterial Pressure Monitoring

Overview

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 .

Full Title of Study: “Detecting Hypotension By Continuous Non-invasive Arterial Pressure Monitoring During Spinal Anaesthesia for Cesarean Section:A Prospective,Randomized, Controlled Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: May 2016

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.

Interventions

  • Drug: phenylephrine
    • 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 in Group C and Group N.If systolic blood pressure did not improve after 1 minute,phenylephrine was administered repeatedly until systolic blood pressure return to normal.

Arms, Groups and Cohorts

  • Experimental: Group C
    • 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.
  • Experimental: Group N
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • the maximum change of systolic blood pressure(SBP),assessed using continuous non-invasive arterial pressure device or intermittent oscillometric arterial pressure measurement
    • Time Frame: 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 Measures

  • Detecting the occurrence of hypotension
    • Time Frame: 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
  • Neonatal outcome was assessed with Apgar scores
    • Time Frame: 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
    • Time Frame: between the spinal anesthetic injection and the delivery of the fetus and placenta,assessed up to 30 mins
  • the incidence of nausea and vomiting on account of hypotension
    • Time Frame: 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.
  • the incidence of dizziness on account of hypotension
    • Time Frame: 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
  • the incidence of dyspnea on account of hypotension
    • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fudan University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Chao Han, Department of Anesthesiology, Department of Obstetrics and Gynecology Hospital, Fudan University – Fudan University
  • Overall Official(s)
    • Shaoqiang Huang, Dr, Study Director, Department of Anesthesiology, Department of Obstetrics and Gynecology Hospital, Fudan University
  • Overall Contact(s)
    • Han, +86 021-33189900-6868, webchao628@163.com

Citations Reporting on Results

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.

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.

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.

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.

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.

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