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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01658631
Other study ID # 2010/42
Secondary ID 2010-A00881-38
Status Completed
Phase N/A
First received August 1, 2012
Last updated November 2, 2016
Start date August 2012
Est. completion date June 2015

Study information

Verified date November 2016
Source Hopital Foch
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Observational

Clinical Trial Summary

The purpose of this study is to compare the non invasive measurement of arterial pressure (Nexfin monitor)with the invasive measurement of arterial pressure (radial artery catheter)

- during induction of general anesthesia,

- during a leg raising test in the Intensive Care Unit


Recruitment information / eligibility

Status Completed
Enrollment 97
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age >18

- ASA II, III or IV

- weight between 40 and 180 kg; BMI < 35

- normal Allen's test and/or hand Doppler examination.

Exclusion Criteria:

- cardiac arrhythmias,

- history of vascular surgery or vascular implant in the upper limb

- Raynaud disease

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Device:
arterial pressure measurement (Nexfin, a noninvasive finger cuff system)


Locations

Country Name City State
France Institut Mutualiste Montsouris Paris
France Hopital Foch Suresnes

Sponsors (1)

Lead Sponsor Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Arterial pressure measurement Blood pressure will be followed for the duration of induction of anesthesia, an expected average of 20 minutes, or for the passive legs raising test, an expected average of 20 minutes No
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