Non-invasive Haemodynamic Monitoring to Predict Spinal Hypotension During Caesarian Section

August 2, 2022 updated by: Gary DUCLOS, Hospital Nord

Can Non-invasive Haemodynamic Monitoring With Clearsight(r) Predict Spinal Hypotension During Caesarian Section? A Prospective Observational Study

Spinal anaesthesia for elective caesarean section is associated with maternal hypotension, secondary to alteration of sympathetic tone and hypovolemia, in up to 70% of cases.

Our objective, in this prospective single-centre observational study, was to assess the ability of change in systolic ejection volume after 45° passive leg raising to predict hypotension after spinal anaesthesia. Systolic ejection volum was monitored with non-invasive Clearsight Device just before elective caesarean section in third trimester pregnant women.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France, 13015
        • Departement anesthesie reanimation hopital nord

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

prospective inclusion of 3 rd trimester pregnant women undergoing spinal anesthesia for elective ceasarean section

Description

Inclusion Criteria:

  • third trimester pregnant women undergoing elective ceasarean section under spinal anesthesia

Exclusion Criteria:

  • emergent ceasarean section
  • eclampsia or pre-eclampsia
  • undergoing anti-hypertensive treatment
  • arythmia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Third trimester pregnant women undergoing ceasarean section
Device: Clearsight monitoring
Non invasive hemodynamic monitoring using a finger cuff Cardiac ultrasound performed to calculate Velocity - Time - integral (VTI) Both intervention are performed before and after a passive leg raising challenge.
Other Names:
  • Cardiac ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic Ejection volume (mL)
Time Frame: 30 minutes
Systolic ejection volume is measured using Clearsight (non invasive monitoring device)
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Velocity - Time - Integral (cm)
Time Frame: 30 minutes
Velocity - Time - Integral is measured using transthoracic cardiac ultrasound
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Nord

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2020

Primary Completion (Actual)

November 26, 2020

Study Completion (Actual)

February 15, 2021

Study Registration Dates

First Submitted

October 19, 2020

First Submitted That Met QC Criteria

October 26, 2020

First Posted (Actual)

October 29, 2020

Study Record Updates

Last Update Posted (Actual)

August 4, 2022

Last Update Submitted That Met QC Criteria

August 2, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Darnord-2020

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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