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

Pregnancy Related Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04608227
• Other study ID #: Darnord-2020
• Status: Completed
• Start date: June 1, 2020
• Est. completion date: February 15, 2021

Study information

• Verified date: August 2022
• Source: Hospital Nord
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 15, 2021
• Est. primary completion date: November 26, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
France	Departement anesthesie reanimation hopital nord	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Nord

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Systolic Ejection volume (mL)	Systolic ejection volume is measured using Clearsight (non invasive monitoring device)	30 minutes
Secondary	Velocity - Time - Integral (cm)	Velocity - Time - Integral is measured using transthoracic cardiac ultrasound	30 minutes

External Links

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