Detecting Hypotension By Continuous Non-invasive Arterial Pressure Monitoring

November 5, 2015 updated by: Chao Han, Fudan University

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

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 .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Department of Anesthesiology, Department of Obstetrics and Gynecology Hospital, Fudan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
Other Names:
  • Phenylephrine Hydrochloride
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.
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.
Other Names:
  • Phenylephrine Hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
between the spinal anesthetic injection and the delivery of the fetus and placenta,assessed up to 30 mins

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
between the spinal anesthetic injection and the delivery of the fetus and placenta,assessed up to 30 mins
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
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
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.
between the spinal anesthetic injection and the delivery of the fetus and placenta,assessed up to 30 mins
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
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
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
between the spinal anesthetic injection and the delivery of the fetus and placenta,assessed up to 30 mins

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Study Director: Shaoqiang Huang, Dr, Department of Anesthesiology, Department of Obstetrics and Gynecology Hospital, Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

May 1, 2016

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

August 13, 2015

First Submitted That Met QC Criteria

August 22, 2015

First Posted (Estimate)

August 25, 2015

Study Record Updates

Last Update Posted (Estimate)

November 9, 2015

Last Update Submitted That Met QC Criteria

November 5, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNAP 01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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