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Cesarean Section ComplicationsNCT04752904

Noninvasive Continuous Blood Pressure Monitoring for Cesarean Delivery

A study testing ClearSight System in people with Cesarean Section Complications and Hypotension, run by Seoul National University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Noninvasive continuous blood pressure monitoring for preventing post-spinal hypotension during cesarean delivery: A randomized controlled trial Read more about this study

Who is it for?
Ages 19 years and older, women only
Conditions the study is for
Cesarean Section Complications, Hypotension
What is being tested?
ClearSight System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
154 participants
Where
1 siteSouth Korea
Study dates
27 Apr 2021to 21 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Multiple fetal pregnancy
  • Preexisting hypertension or pregnancy-induced hypertension
  • Underlying heart disease
  • Underlying cerebrovascular disease
  • Known fetal anomaly
  • Contraindicated in spinal anesthesia
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Hospital

    Seoul, 03080

Other trials in South Korea

About this study

Official title: 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

Read the 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

Being tested
ClearSight System
Keywords
noninvasive continuous blood pressure monitoring
Medical subject headings
Hypotension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ClearSight SystemDevice

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

Study groups in NCT04752904
Study groupRoleWhat they receive
ClearSight groupExperimentalNon-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.
Receives: Device: ClearSight System
Control groupNo interventionThe 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of hypotension by individualized methods

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

    Measured: From spinal anesthesia to delivery

Secondary outcomes (20)

  1. Incidence of hypotension by standard methods

    Hypotension was defined as MBP<65mmHg

    Measured: From spinal anesthesia to delivery

  2. Time-weighted average SBP<80% of baseline SBP

    Time-weighted average SBP<80% of baseline SBP

    Measured: From spinal anesthesia to delivery

  3. Time-weighted average MAP <65mmHg

    Time-weighted average MAP <65mmHg

    Measured: From spinal anesthesia to delivery

  4. Incidence of intraoperative severe hypotension

    Defined as: SBP < 70% of baseline SBP

    Measured: From spinal anesthesia to delivery

  5. Incidence of intraoperative symptomatic hypotension

    Defined as: hypotension plus nausea and/or vomiting and/or dizziness and/or breathlessness

    Measured: From spinal anesthesia to delivery

  6. Incidence of nausea, vomiting, dizziness, breathlessness

    Incidence of nausea, vomiting, dizziness, breathlessness

    Measured: From spinal anesthesia to delivery

  7. Incidence of intraoperative Hypertension

    SBP> 120% of baseline SBP

    Measured: From spinal anesthesia to delivery

  8. Maximum, Minimum recorded SBP, DBP, MBP

    Maximum, Minimum recorded SBP, DBP, MBP

    Measured: From spinal anesthesia to delivery

  9. Cumulative duration of hypotension

    Cumulative duration of hypotension

    Measured: From spinal anesthesia to delivery

  10. Number of hypotensive episodes

    Number of hypotensive episodes

    Measured: From spinal anesthesia to delivery

  11. Onset time of hypotension

    Onset time of hypotension

    Measured: From spinal anesthesia to delivery

  12. Cumulative consumptions of vasopressors

    Cumulative consumptions of vasopressors

    Measured: From spinal anesthesia to delivery

  13. Incidence of bradycardia

    HR (heart rate) <50 bpm

    Measured: From spinal anesthesia to delivery

  14. Incidence of atropine use

    Incidence of atropine use

    Measured: From spinal anesthesia to delivery

  15. Minimum heart rate

    Minimum heart rate

    Measured: From spinal anesthesia to delivery

  16. Cardiac output, stroke volume

    only in ClearSight System group

    Measured: From spinal anesthesia to delivery

  17. The analysis of the differences between the test method (ClearSight) and reference method

    Bland-Altman analysis

    Measured: From spinal anesthesia to delivery

  18. Apgar Score

    1 minute, 5 minutes

    Measured: at 1 minute after delivery and 5 minutes after delivery

  19. Umbilical arterial blood

    Arterial blood gas analysis results

    Measured: within 10 minutes after delivery

  20. Umbilical arterial pH

    <7.2

    Measured: within 10 minutes after delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2021
  2. Study start27 Apr 2021
  3. Primary completion26 Oct 2022
  4. Study completion21 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
randomized double blind controlled trial
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
154 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04752904
Sponsor's protocol ID
2010-093-1165
Status last verified
Dec 2022
First submitted
5 Feb 2021
Last updated
28 Dec 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31977628

  • 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.

    PubMed 30335625

  • 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.

    PubMed 31531852

  • 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.

    PubMed 29090733

  • 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.

    PubMed 30267340

  • 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.

    PubMed 27195632

  • 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.

    PubMed 30649073

  • 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.

    PubMed 30562226

  • 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.

    PubMed 32682556

  • 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.

    PubMed 24740992

  • 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.

    PubMed 26401736

  • 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.

    PubMed 22382920

  • 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.

    PubMed 29511971

Questions about this trial

What is this clinical trial studying?

A study testing ClearSight System in people with Cesarean Section Complications and Hypotension, run by Seoul National University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of hypotension by individualized methods (time frame: From spinal anesthesia to delivery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04752904, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2022.

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