Noninvasive Continuous Blood Pressure Monitoring for Cesarean Delivery

NCT04752904 | Completed DMC

• 1 other identifier: 2010-093-1165
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cesarean Section Complications; Hypotension

Keywords

noninvasive continuous blood pressure monitoring

Outcome Measures

Primary Outcomes (1)

• Incidence of hypotension by individualized methods

  Hypotension was defined as: SBP\<80% of baseline SBP

  From spinal anesthesia to delivery

Secondary Outcomes (20)

• Incidence of hypotension by standard methods

  From spinal anesthesia to delivery

• Time-weighted average SBP<80% of baseline SBP

  From spinal anesthesia to delivery

• Time-weighted average MAP <65mmHg

  From spinal anesthesia to delivery

• Incidence of intraoperative severe hypotension

  From spinal anesthesia to delivery

• Incidence of intraoperative symptomatic hypotension

  From spinal anesthesia to delivery

Study Arms (2)

ClearSight group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

ClearSight System DEVICE

Non-invasive, continuous blood pressure is monitored using ClearSight Sytem

ClearSight group

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (13)

• 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.

  PMID: 31977628 BACKGROUND

• 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.

  PMID: 30335625 BACKGROUND

• 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.

  PMID: 31531852 BACKGROUND

• 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.

  PMID: 29090733 BACKGROUND

• 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.

  PMID: 30267340 BACKGROUND

• 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.

  PMID: 27195632 BACKGROUND

• 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.

  PMID: 30649073 BACKGROUND

• 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.

  PMID: 30562226 BACKGROUND

• 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.

  PMID: 32682556 BACKGROUND

• 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.

  PMID: 24740992 BACKGROUND

• 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.

  PMID: 26401736 BACKGROUND

• 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.

  PMID: 22382920 BACKGROUND

• 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.

  PMID: 29511971 BACKGROUND

MeSH Terms

Conditions

Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Sun-Kyung Park, M.D

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: randomized double blind controlled trial

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 12, 2021
• Study Start: April 27, 2021
• Primary Completion: October 26, 2022
• Study Completion: December 21, 2022
• Last Updated: December 28, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)