Clinical Trial: Detecting Hypotension By Continuous Non-invasive Arterial Pressure Monitoring

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Fudan University

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome:

  • 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 90mmHg
  • 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 maternal adverse reactions on account of hypotension [ Time Frame: between the spinal anesthetic injection and the delivery of the fetus and placenta,assessed up to 30 mins ]
    nausea, vomiting,dizziness and dyspnea of maternal


Information By: Fudan University

Dates:
Date Received: August 13, 2015
Date Started: September 2015
Date Completion: June 2016
Last Updated: November 5, 2015
Last Verified: November 2015