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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03046784
Other study ID # darnord2017-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2017
Est. completion date May 31, 2017

Study information

Verified date April 2020
Source Hospital Nord
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This prospective and observational trial over 55 pregnant women (third trimester) compares non invasive haemodynamic monitoring using Nexfin technology and ultrasonography technic


Recruitment information / eligibility

Status Completed
Enrollment 55
Est. completion date May 31, 2017
Est. primary completion date March 31, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- third trimester of pregnancy

- Non-labouring pregnant women

- accepting study

Exclusion Criteria:

- refusal of study

- first or second trimester of pregnancy

Study Design


Intervention

Other:
haemodynamic evaluation
continous haemodynamic monitoring is performed with digital Nexfin captor in two positions. in the same time transthoracic cardiac ultrasonography is performed to calculate cardiac output using velocity time index of aortic outflow chamber.

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, 

References & Publications (2)

Lee SW, Khaw KS, Ngan Kee WD, Leung TY, Critchley LA. Haemodynamic effects from aortocaval compression at different angles of lateral tilt in non-labouring term pregnant women. Br J Anaesth. 2012 Dec;109(6):950-6. doi: 10.1093/bja/aes349. Epub 2012 Oct 11. — View Citation

Montenij LJ, Buhre WF, Jansen JR, Kruitwagen CL, de Waal EE. Methodology of method comparison studies evaluating the validity of cardiac output monitors: a stepwise approach and checklist. Br J Anaesth. 2016 Jun;116(6):750-8. doi: 10.1093/bja/aew094. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Cardiac output measure Cardiac output is measured with non-invasive digital Nexfin technology (ml/min) and compared with transthoracic echocardiographic measure of cardiac output (ml/min) used as reference.
Echographic cardiac output (ml/min) is measured as the produce of cross sectional aera of left ventricular outflow track (cm²) multiplied by velocity time index (cm) multiplied by heart rate (beat/min)
30 minutes
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