Non-invasive Haemodynamic Monitoring to Predict Spinal Hy... | NCT04608227

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

NCT04608227

Sponsor

Hospital Nord

Status

Completed

Last Update Posted

Aug 4, 2022Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Hypotension
Pregnancy Related
Spinal Anesthetics Causing Adverse Effects in Therapeutic Use

Interventions

Clearsight monitoring

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2020Actual

Primary Completion Date

Nov 26, 2020Actual

Completion Date

Feb 15, 2021Actual

First Submitted Date

Oct 19, 2020

First Submission Date that Met QC Criteria

Oct 26, 2020

First Posted Date

Oct 29, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 2, 2022

Last Update Posted Date

Aug 4, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Third trimester pregnant women undergoing ceasarean section			Device: Clearsight monitoring

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Systolic Ejection volume (mL)	Systolic ejection volume is measured using Clearsight (non invasive monitoring device)	30 minutes

Secondary Outcomes

Measure	Description	Time Frame
Velocity - Time - Integral (cm)	Velocity - Time - Integral is measured using transthoracic cardiac ultrasound	30 minutes

Other Outcomes

Not provided

Eligibility Module

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
arythmia

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Only pregmant women

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

prospective inclusion of 3 rd trimester pregnant women undergoing spinal anesthesia for elective ceasarean section

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Departement anesthesie reanimation hopital nord		Marseille		13015	France

Label	URL
Related Info	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007022	Hypotension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided