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Detecting Hypotension By Continuous Non-invasive Arterial Pressure Monitoring

Primary Purpose

Hypotension

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
phenylephrine
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypotension focused on measuring obstetric, anesthesia, hypotension, arterial pressure, measurement techniques

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Anesthesiology, Department of Obstetrics and Gynecology Hospital, Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group C

Group N

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

the maximum change of systolic blood pressure(SBP),assessed using continuous non-invasive arterial pressure device or intermittent oscillometric arterial pressure measurement
(baseline SBP-minimum SBP)/baseline SBP

Secondary Outcome Measures

Detecting the occurrence of hypotension
systolic blood pressure decreased by over 20% of the baseline or systolic blood pressure lower than 100mmHg
Neonatal outcome was assessed with Apgar scores
umbilical cord blood gases analysis at birth
the incidence of nausea and vomiting on account of hypotension
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
assessment:yes=patient had dizziness,no=patient had no dizziness
the incidence of dyspnea on account of hypotension
assessment:yes=patient had dyspnea,no=patient had no dyspnea

Full Information

First Posted
August 13, 2015
Last Updated
November 5, 2015
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT02532270
Brief Title
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

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypotension
Keywords
obstetric, anesthesia, hypotension, arterial pressure, measurement techniques

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group C
Arm Type
Experimental
Arm Description
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.
Arm Title
Group N
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
phenylephrine
Other Intervention Name(s)
Phenylephrine Hydrochloride
Intervention Description
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.
Primary Outcome Measure Information:
Title
the maximum change of systolic blood pressure(SBP),assessed using continuous non-invasive arterial pressure device or intermittent oscillometric arterial pressure measurement
Description
(baseline SBP-minimum SBP)/baseline SBP
Time Frame
between the spinal anesthetic injection and the delivery of the fetus and placenta,assessed up to 30 mins
Secondary Outcome Measure Information:
Title
Detecting the occurrence of hypotension
Description
systolic blood pressure decreased by over 20% of the baseline or systolic blood pressure lower than 100mmHg
Time Frame
between the spinal anesthetic injection and the delivery of the fetus and placenta,assessed up to 30 mins
Title
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
Title
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
Title
the incidence of nausea and vomiting on account of hypotension
Description
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.
Time Frame
between the spinal anesthetic injection and the delivery of the fetus and placenta,assessed up to 30 mins
Title
the incidence of dizziness on account of hypotension
Description
assessment:yes=patient had dizziness,no=patient had no dizziness
Time Frame
between the spinal anesthetic injection and the delivery of the fetus and placenta,assessed up to 30 mins
Title
the incidence of dyspnea on account of hypotension
Description
assessment:yes=patient had dyspnea,no=patient had no dyspnea
Time Frame
between the spinal anesthetic injection and the delivery of the fetus and placenta,assessed up to 30 mins

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Han
Phone
+86 021-33189900-6868
Email
webchao628@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaoqiang Huang, Dr
Organizational Affiliation
Department of Anesthesiology, Department of Obstetrics and Gynecology Hospital, Fudan University
Official's Role
Study Director
Facility Information:
Facility Name
Department of Anesthesiology, Department of Obstetrics and Gynecology Hospital, Fudan University
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Han
Phone
+86 021-33189900-6868
Email
webchao628@163.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
22798273
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.
Results Reference
result
PubMed Identifier
20627878
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.
Results Reference
result
PubMed Identifier
19859776
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.
Results Reference
result
PubMed Identifier
11916798
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.
Results Reference
result
PubMed Identifier
19716536
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.
Results Reference
result

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Detecting Hypotension By Continuous Non-invasive Arterial Pressure Monitoring

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