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

Completed

• Conditions: Hypotension; Pregnancy Related; Spinal Anesthetics Causing Adverse Effects in Therapeutic Use
• Interventions: Device: Clearsight monitoring

• Registration Number: NCT04608227
• Lead Sponsor: Hospital Nord

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-01
• Study First Submitted: 2020-10-19
• Study First Submitted QC: 2020-10-26
• Study First Posted: 2020-10-29
• Primary Completion: 2020-11-26
• Study Completion: 2021-02-15
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-02
• Last Update Posted: 2022-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Third trimester pregnant women undergoing ceasarean section	Clearsight monitoring	-

Primary Outcome Measures

Name	Time	Method
Systolic Ejection volume (mL)	30 minutes	Systolic ejection volume is measured using Clearsight (non invasive monitoring device)

Secondary Outcome Measures

Name	Time	Method
Velocity - Time - Integral (cm)	30 minutes	Velocity - Time - Integral is measured using transthoracic cardiac ultrasound

Trial Locations

Locations (1)

Departement anesthesie reanimation hopital nord; 🇫🇷 Marseille, France