Noninvasive Continuous Blood Pressure Monitoring for Cesarean Delivery

Noninvasive Continuous Blood Pressure Monitoring for Preventing Post-spinal Hypotension During Cesarean Delivery: A Randomized Controlled Trial

Noninvasive continuous blood pressure monitoring for preventing post-spinal hypotension during cesarean delivery: A randomized controlled trial

Study Overview

• Status: Completed
• Conditions: Cesarean Section Complications; Hypotension
• Intervention / Treatment: Device: ClearSight System

Detailed Description

The aim of this study was to find out whether the incidence of hypotension during surgery can be reduced in the case of non-invasive, continuous blood pressure monitoring using the ClearSight System in patients undergoing cesarean section under spinal anesthesia, compared to the case of using conventional noninvasive blood pressure monitoring

• Study Type: Interventional
• Enrollment (Actual): 154
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Adult mothers who are pregnant with single fetuses over 35 weeks gestational age undergoing planned cesarean delivery under spinal anesthesia

Exclusion Criteria:

• Multiple fetal pregnancy

  • Preexisting hypertension or pregnancy-induced hypertension

    • Underlying heart disease

      • Underlying cerebrovascular disease

        • Known fetal anomaly

          • Contraindicated in spinal anesthesia

            • Any sign of onset of labor

              • Body weight <45 kg or body weight> 90 kg

                • Height <145cm or height> 180cm

                  • All other cases in which researchers determine to be inappropriate for this clinical trial

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ClearSight group; Non-invasive, continuous blood pressure is monitored using ClearSight Sytem, with a finger cuff around the middle finger, and the anesthesiologist manages blood pressure based on this.	Device: ClearSight System; Non-invasive, continuous blood pressure is monitored using ClearSight Sytem
No Intervention: Control group; The blood pressure is measured at 1-minute intervals by non-invasive blood pressure monitor using the arm cuff, and the anesthesiologist in charge manages the blood pressure based on the measured blood pressure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of hypotension by individualized methods	Hypotension was defined as: SBP<80% of baseline SBP	From spinal anesthesia to delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of hypotension by standard methods	Hypotension was defined as MBP<65mmHg	From spinal anesthesia to delivery
Time-weighted average SBP<80% of baseline SBP	Time-weighted average SBP<80% of baseline SBP	From spinal anesthesia to delivery
Time-weighted average MAP <65mmHg	Time-weighted average MAP <65mmHg	From spinal anesthesia to delivery
Incidence of intraoperative severe hypotension	Defined as: SBP < 70% of baseline SBP	From spinal anesthesia to delivery
Incidence of intraoperative symptomatic hypotension	Defined as: hypotension plus nausea and/or vomiting and/or dizziness and/or breathlessness	From spinal anesthesia to delivery
Incidence of nausea, vomiting, dizziness, breathlessness	Incidence of nausea, vomiting, dizziness, breathlessness	From spinal anesthesia to delivery
Incidence of intraoperative Hypertension	SBP> 120% of baseline SBP	From spinal anesthesia to delivery
Maximum, Minimum recorded SBP, DBP, MBP	Maximum, Minimum recorded SBP, DBP, MBP	From spinal anesthesia to delivery
Cumulative duration of hypotension	Cumulative duration of hypotension	From spinal anesthesia to delivery
Number of hypotensive episodes	Number of hypotensive episodes	From spinal anesthesia to delivery
Onset time of hypotension	Onset time of hypotension	From spinal anesthesia to delivery
Cumulative consumptions of vasopressors	Cumulative consumptions of vasopressors	From spinal anesthesia to delivery
Incidence of bradycardia	HR (heart rate) <50 bpm	From spinal anesthesia to delivery
Incidence of atropine use	Incidence of atropine use	From spinal anesthesia to delivery
Minimum heart rate	Minimum heart rate	From spinal anesthesia to delivery
Cardiac output, stroke volume	only in ClearSight System group	From spinal anesthesia to delivery
The analysis of the differences between the test method (ClearSight) and reference method	Bland-Altman analysis	From spinal anesthesia to delivery
Apgar Score	1 minute, 5 minutes	at 1 minute after delivery and 5 minutes after delivery
Umbilical arterial blood	Arterial blood gas analysis results	within 10 minutes after delivery
Umbilical arterial pH	<7.2	within 10 minutes after delivery

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Sun-Kyung Park, M.D, Seoul National University Hospital

Publications and helpful links

General Publications

• Kinsella SM, Carvalho B, Dyer RA, Fernando R, McDonnell N, Mercier FJ, Palanisamy A, Sia ATH, Van de Velde M, Vercueil A; Consensus Statement Collaborators. International consensus statement on the management of hypotension with vasopressors during caesarean section under spinal anaesthesia. Anaesthesia. 2018 Jan;73(1):71-92. doi: 10.1111/anae.14080. Epub 2017 Nov 1. No abstract available.
• Wei C, Qian J, Zhang Y, Chang X, Hu H, Xiao F. Norepinephrine for the prevention of spinal-induced hypotension during caesarean delivery under combined spinal-epidural anaesthesia: Randomised, double-blind, dose-finding study. Eur J Anaesthesiol. 2020 Apr;37(4):309-315. doi: 10.1097/EJA.0000000000001152.
• Hasanin AM, Amin SM, Agiza NA, Elsayed MK, Refaat S, Hussein HA, Rouk TI, Alrahmany M, Elsayad ME, Elshafaei KA, Refaie A. Norepinephrine Infusion for Preventing Postspinal Anesthesia Hypotension during Cesarean Delivery: A Randomized Dose-finding Trial. Anesthesiology. 2019 Jan;130(1):55-62. doi: 10.1097/ALN.0000000000002483.
• Fitzgerald JP, Fedoruk KA, Jadin SM, Carvalho B, Halpern SH. Prevention of hypotension after spinal anaesthesia for caesarean section: a systematic review and network meta-analysis of randomised controlled trials. Anaesthesia. 2020 Jan;75(1):109-121. doi: 10.1111/anae.14841. Epub 2019 Sep 18.
• Juri T, Suehiro K, Kimura A, Mukai A, Tanaka K, Yamada T, Mori T, Nishikawa K. Impact of non-invasive continuous blood pressure monitoring on maternal hypotension during cesarean delivery: a randomized-controlled study. J Anesth. 2018 Dec;32(6):822-830. doi: 10.1007/s00540-018-2560-2. Epub 2018 Sep 28.
• Bartels K, Esper SA, Thiele RH. Blood Pressure Monitoring for the Anesthesiologist: A Practical Review. Anesth Analg. 2016 Jun;122(6):1866-79. doi: 10.1213/ANE.0000000000001340.
• Rogge DE, Nicklas JY, Schon G, Grothe O, Haas SA, Reuter DA, Saugel B. Continuous Noninvasive Arterial Pressure Monitoring in Obese Patients During Bariatric Surgery: An Evaluation of the Vascular Unloading Technique (Clearsight system). Anesth Analg. 2019 Mar;128(3):477-483. doi: 10.1213/ANE.0000000000003943.
• Noto A, Sanfilippo F, De Salvo G, Crimi C, Benedetto F, Watson X, Cecconi M, David A. Noninvasive continuous arterial pressure monitoring with Clearsight during awake carotid endarterectomy: A prospective observational study. Eur J Anaesthesiol. 2019 Feb;36(2):144-152. doi: 10.1097/EJA.0000000000000938.
• Ngan Kee WD, Lee SWY, Ng FF, Lee A. Norepinephrine or phenylephrine during spinal anaesthesia for Caesarean delivery: a randomised double-blind pragmatic non-inferiority study of neonatal outcome. Br J Anaesth. 2020 Oct;125(4):588-595. doi: 10.1016/j.bja.2020.05.057. Epub 2020 Jul 15.
• Vos JJ, Poterman M, Mooyaart EA, Weening M, Struys MM, Scheeren TW, Kalmar AF. Comparison of continuous non-invasive finger arterial pressure monitoring with conventional intermittent automated arm arterial pressure measurement in patients under general anaesthesia. Br J Anaesth. 2014 Jul;113(1):67-74. doi: 10.1093/bja/aeu091. Epub 2014 Apr 15.
• Chen G, Chung E, Meng L, Alexander B, Vu T, Rinehart J, Cannesson M. Impact of non invasive and beat-to-beat arterial pressure monitoring on intraoperative hemodynamic management. J Clin Monit Comput. 2012 Apr;26(2):133-40. doi: 10.1007/s10877-012-9344-2. Epub 2012 Mar 1.
• Juri T, Suehiro K, Kimura A, Mukai A, Tanaka K, Yamada T, Mori T, Nishikawa K. Impact of continuous non-invasive blood pressure monitoring on hemodynamic fluctuation during general anesthesia: a randomized controlled study. J Clin Monit Comput. 2018 Dec;32(6):1005-1013. doi: 10.1007/s10877-018-0125-4. Epub 2018 Mar 6.
• Lawicka M, Malek A, Antczak D, Wajlonis A, Owczuk R. Non-invasive haemodynamic measurements with Nexfin predict the risk of hypotension following spinal anaesthesia. Anaesthesiol Intensive Ther. 2015;47(4):303-8. doi: 10.5603/AIT.2015.0048.

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2021
• Primary Completion (Actual): October 26, 2022
• Study Completion (Actual): December 21, 2022

Study Registration Dates

• First Submitted: February 5, 2021
• First Submitted That Met QC Criteria: February 9, 2021
• First Posted (Actual): February 12, 2021

Study Record Updates

• Last Update Posted (Estimate): December 28, 2022
• Last Update Submitted That Met QC Criteria: December 26, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: noninvasive continuous blood pressure monitoring
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: 2010-093-1165

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No