Detecting Hypotension By Continuous Non-invasive Arterial Pressure Monitoring
NCT ID: NCT02532270
Last Updated: 2015-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2015-09-30
2016-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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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.
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.
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.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* pregnancy week above 36
Exclusion Criteria
* cardiac arrhythmia
* vascular pathologies of the upper limbs (recent vascular surgery, Raynaud's diseaseļ¼ vascular stenosis)
* contraindication for spinal anaesthesia
* emergency case
18 Years
FEMALE
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Chao Han
Department of Anesthesiology, Department of Obstetrics and Gynecology Hospital, Fudan University
Principal Investigators
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Shaoqiang Huang, Dr
Role: STUDY_DIRECTOR
Department of Anesthesiology, Department of Obstetrics and Gynecology Hospital, Fudan University
Locations
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Department of Anesthesiology, Department of Obstetrics and Gynecology Hospital, Fudan University
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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CNAP 01
Identifier Type: -
Identifier Source: org_study_id
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