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Concordance of Capillary Blood Biological Samples With Conventional Venousbiological Blood Samples. (CAPIVEIN)

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ClinicalTrials.gov Identifier: NCT03890146
Recruitment Status : Recruiting
First Posted : March 26, 2019
Last Update Posted : December 9, 2019
Sponsor:
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Tracking Information
First Submitted Date February 18, 2019
First Posted Date March 26, 2019
Last Update Posted Date December 9, 2019
Actual Study Start Date December 20, 2018
Estimated Primary Completion Date December 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 25, 2019)
  • concordance between capillary and veinous sampling for natremia result [ Time Frame: 1 hour ]
    The concordance between the biological results obtained by capillary puncture analysed on the GEM 4000 resuscitation machine (Werfen), and the biological results by venous sampling analysed in the standard biology laboratory on the Gen. 2 COBAS machine (Roche) for natremia
  • concordance between capillary and veinous sampling for kalemia result [ Time Frame: 1 hour ]
    The concordance between the biological results obtained by capillary puncture analysed on the GEM 4000 resuscitation machine (Werfen), and the biological results by venous sampling analysed in the standard biology laboratory on the Gen. 2 COBAS machine (Roche) for kalemia
  • concordance between capillary and veinous sampling for chloremiaresult [ Time Frame: 1 hour ]
    The concordance between the biological results obtained by capillary puncture analysed on the GEM 4000 resuscitation machine (Werfen), and the biological results by venous sampling analysed in the standard biology laboratory on the Gen. 2 COBAS machine (Roche) for chloremia
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Concordance of Capillary Blood Biological Samples With Conventional Venousbiological Blood Samples.
Official Title Concordance of Capillary Blood Biological Samples Analyzed in Delocalized Biology With Conventional Venous Biological Blood Samples Analyzed at the Biology Laboratory
Brief Summary The main objectives are to evaluate the concordance between the results of natremia, kalaemia and blood sugar levels obtained 1) by capillary puncture, analysed on a delocalized resuscitation machine GEM 4000 (Werfen) and 2) by venous sampling, analysed on the machine of the standard biology laboratory Gen. 2 COBAS (Roche).
Detailed Description

The completion of a biological test suits a succession of codified steps:

  • Medical prescription
  • The pre-analytic phase (preparation of the material, completion of the sample, transport of the sample and preparation of it)
  • The analytical phase
  • The post-analytic phase (validation of the result obtained and the dissemination of it to the prescriber, usually the clinician, who is then able to make a medical decision) This succession of steps involves, as part of a classical journey, many stakeholders (doctors, nurses, couriers, laboratory technicians, medical biologists) in different places.

Outsourced biology (care test point, POCT) refers to the analysis of biological samples outside the central laboratory. The sample is most often carried out, transported and analyzed by the same person on a machine near the patient or in the service and therefore in the absence of direct control of a specialized laboratory technician or a medical biologist, who remains however responsible for good practice, maintenance of the device and validity of the results.

The completion of biological examinations is regulated by differents Articles. The outsourced biology (ADBD) sampling analysis can be carried out in the hospital, in most departments, and also outside the hospital (pharmacies, city offices or even in the patient's own home). On portable devices, usually highly specialized, and these fixed allowing a greater diversity of tests.

Its development is booming with annual growth estimated in 2006 at 15.5% in the United States.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population patients hospitalized in the intensive care unit for any reason
Condition Biochemical Dysfunction
Intervention Not Provided
Study Groups/Cohorts intensive care patients
patient hospitalised in intensive care unit veinous and capillary ponction
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 25, 2019)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 21, 2020
Estimated Primary Completion Date December 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patient over the age of 18
  • Affiliate or beneficiary of a social security scheme
  • Express consent to participate in the study

Exclusion Criteria:

  • Patient benefiting from a legal protection measure
  • Patient not communicating
  • Pregnant or breastfeeding woman
  • Peripheral edema (taking more than 5 Kg since entering the service)
  • Patient in shock (mean arterial pressure < 65 mmHg or continuous catecholamine administration)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Amelie Yavchitz, MD, PhD 0148036454 ext 33 ayavchitz@for.paris
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03890146
Other Study ID Numbers 2018-A01880-55
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Fondation Ophtalmologique Adolphe de Rothschild
Study Sponsor Fondation Ophtalmologique Adolphe de Rothschild
Collaborators Not Provided
Investigators
Principal Investigator: Nefeli Nasika Fonadtion Afolphe Rothschild
PRS Account Fondation Ophtalmologique Adolphe de Rothschild
Verification Date December 2019