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Clinical Trials/NCT04608227
NCT04608227
Completed
Not Applicable

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

Hospital Nord1 site in 1 country40 target enrollmentJune 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypotension
Sponsor
Hospital Nord
Enrollment
40
Locations
1
Primary Endpoint
Systolic Ejection volume (mL)
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2020
End Date
February 15, 2021
Last Updated
3 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Hospital Nord
Responsible Party
Principal Investigator
Principal Investigator

Gary DUCLOS

Medical Doctor

Hospital Nord

Eligibility Criteria

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

Outcomes

Primary Outcomes

Systolic Ejection volume (mL)

Time Frame: 30 minutes

Systolic ejection volume is measured using Clearsight (non invasive monitoring device)

Secondary Outcomes

  • Velocity - Time - Integral (cm)(30 minutes)

Study Sites (1)

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