Pregnancy Related Clinical Trial
Official title:
Non-invasive Haemodynamic Monitoring in Pregnancy : Comparison Between Ultrasound and Nexfin Technology
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 |
Verified date | April 2020 |
Source | Hospital Nord |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This prospective and observational trial over 55 pregnant women (third trimester) compares non invasive haemodynamic monitoring using Nexfin technology and ultrasonography technic
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 |
Country | Name | City | State |
---|---|---|---|
France | Departement anesthesie reanimation hopital nord | Marseille |
Lead Sponsor | Collaborator |
---|---|
Hospital Nord |
France,
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
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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