Detecting Hypotension By Continuous Non-invasive Arterial Pressure Monitoring

Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02532270
• Other study ID #: CNAP 01
• Status: Recruiting
• Phase: N/A
• First received: August 13, 2015
• Last updated: November 5, 2015
• Start date: September 2015
• Est. completion date: June 2016

Study information

• Verified date: November 2015
• Source: Fudan University
• Contact: Han
• Phone: +86 021-33189900-6868
• Email: webchao628[@]163.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypotension

Intervention

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.

Locations

Country	Name	City	State
China	Department of Anesthesiology, Department of Obstetrics and Gynecology Hospital, Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View 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. 2 — View Citation

Jeleazcov C, Krajinovic L, Münster T, Birkholz T, Fried R, Schüttler 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( — View 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 c — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	between the spinal anesthetic injection and the delivery of the fetus and placenta,assessed up to 30 mins	Yes
Secondary	Detecting the occurrence of hypotension	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	Yes
Secondary	Neonatal outcome was assessed with Apgar scores		between the spinal anesthetic injection and the delivery of the fetus and placenta,assessed up to 30 mins	Yes
Secondary	umbilical cord blood gases analysis at birth		between the spinal anesthetic injection and the delivery of the fetus and placenta,assessed up to 30 mins	Yes
Secondary	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.	between the spinal anesthetic injection and the delivery of the fetus and placenta,assessed up to 30 mins	Yes
Secondary	the incidence of dizziness on account of hypotension	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	Yes
Secondary	the incidence of dyspnea on account of hypotension	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	Yes