Noninvasive Continuous Blood Pressure Monitoring for Cesarean Delivery

Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04752904
• Other study ID #: 2010-093-1165
• Status: Completed
• Phase: N/A
• Start date: April 27, 2021
• Est. completion date: December 21, 2022

Study information

• Verified date: December 2022
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: December 21, 2022
• Est. primary completion date: October 26, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section Complications
• Hypotension

Intervention

Device:
• ClearSight System
Non-invasive, continuous blood pressure is monitored using ClearSight Sytem

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (13)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

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