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Trial record 61 of 648 for:    test AND point-of-care

The Evaluation of Point of Care Testing for Determining Hemoglobin Levels in Geriatric Intensive Care Patients (hb levels)

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ClinicalTrials.gov Identifier: NCT03509987
Recruitment Status : Completed
First Posted : April 27, 2018
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
MEHTAP HONCA, MD, Kecioren Education and Training Hospital

Tracking Information
First Submitted Date  ICMJE April 16, 2018
First Posted Date  ICMJE April 27, 2018
Last Update Posted Date May 1, 2018
Actual Study Start Date  ICMJE March 1, 2018
Actual Primary Completion Date April 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 26, 2018)
hemoglobin levels [ Time Frame: 1 months ]
comparing hemoglobin (Hb) levels determined by point of care testing HemaCue and arterial blood gas analyzer with an automated hematology analyzer in critically ill geriatric patients.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03509987 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Evaluation of Point of Care Testing for Determining Hemoglobin Levels in Geriatric Intensive Care Patients
Official Title  ICMJE The Evaluation of Point of Care Testing for Determining Hemoglobin Levels in Geriatric Intensive Care Patients
Brief Summary The aim of the present study was to compare hemoglobin (Hb) levels determined by point of care testing HemaCue and arterial blood gas analyzer with an automated hematology analyzer in critically ill geriatric patients.Forty geriatric patients requiring intensive care treatment were included in the study. Arterial blood sample was analyzed using HemaCue (HbHemaCueArterial), blood gas analyzer (Techno Medica, Gastat1800 series) (HbBGA) and an automated hematology analyzer (Cell Dyne 3700 System, Abbot Laboratories)(HbLab) as a reference method. Capillary blood measurements were performed (HbHemaCueCapillary) by HemaCue at bedside.
Detailed Description The aim of the present study was to compare hemoglobin (Hb) levels determined by point of care testing HemaCue and arterial blood gas analyzer with an automated hematology analyzer in critically ill geriatric patients.Forty geriatric patients requiring intensive care treatment were included in the study. Arterial blood sample was analyzed using HemaCue (HbHemaCueArterial), blood gas analyzer (Techno Medica, Gastat1800 series) (HbBGA) and an automated hematology analyzer (Cell Dyne 3700 System, Abbot Laboratories)(HbLab) as a reference method. Capillary blood measurements were performed (HbHemaCueCapillary) by HemaCue at bedside. Bland Altman Analysis was applied to the results .
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Point-of-Care Systems
Intervention  ICMJE Device: HemaCue
comparing hemoglobin (Hb) levels determined by point of care testing HemaCue and arterial blood gas analyzer with an automated hematology analyzer in critically ill geriatric patients.
Other Name: Blood gas analyser
Study Arms  ICMJE hb analysis with Hemacue
Hb analysis with Hemacue and with arterial blood gas analyser in geriatric ill patients requiring intensive care
Intervention: Device: HemaCue
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  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 26, 2018)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 5, 2018
Actual Primary Completion Date April 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • geriatric patients requiring intensive care treatment

Exclusion Criteria:

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03509987
Other Study ID Numbers  ICMJE KeciorenTRH
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party MEHTAP HONCA, MD, Kecioren Education and Training Hospital
Study Sponsor  ICMJE Kecioren Education and Training Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: MEHTAP HONCA, Ass. Prof Kecioren training and research Hospital , Department of Anesthesiology and Reanimation
PRS Account Kecioren Education and Training Hospital
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP