Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04608227
Enrollment
40
Registered
2020-10-29
Start date
2020-06-01
Completion date
2021-02-15
Last updated
2022-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypotension, Pregnancy Related, Spinal Anesthetics Causing Adverse Effects in Therapeutic Use

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.

Interventions

DEVICEClearsight 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.

Sponsors

Hospital Nord
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Systolic Ejection volume (mL)30 minutesSystolic ejection volume is measured using Clearsight (non invasive monitoring device)

Secondary

MeasureTime frameDescription
Velocity - Time - Integral (cm)30 minutesVelocity - Time - Integral is measured using transthoracic cardiac ultrasound

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026