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OpenTrials
Completed

NCT Number: NCT04608227

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

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.

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Key information

Conditions

Hypotension Cardiovascular Diseases Pregnancy Related Spinal Anesthetics Causing Adverse Effects in Therapeutic Use Vascular Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Departement anesthesie reanimation hopital nord

Marseille, 13015, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clearsight monitoring

Device

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

Primary outcomes

  1. Systolic Ejection volume (mL)

    Time frame: 30 minutes

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

Secondary outcomes

  1. Velocity - Time - Integral (cm)

    Time frame: 30 minutes

    Velocity - Time - Integral is measured using transthoracic cardiac ultrasound

Sponsors and collaborators

Lead sponsor

Hospital Nord

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Oct 29, 2020
Registry last updated
Aug 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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