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Comparison of the Accuracy of Non-invasive Hemoglobin Measurement (SpHb) and Vena Cava Inferior Ultrasound

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ClinicalTrials.gov Identifier: NCT02944851
Recruitment Status : Completed
First Posted : October 26, 2016
Last Update Posted : May 16, 2018
Sponsor:
Information provided by (Responsible Party):
Adnan Yamanoğlu, Haseki Training and Research Hospital

Brief Summary:

The aim of this work is determine the more successful noninvasive method by comparison of two noninvasive methods ( IVC ultrasound - noninvasive hemoglobin measurement (SpHb)) that used in the detection of patients with blood loss.

The works were completed in 6 months. The study was conducted at the blood donation center and in Emergency department. Vital parameters were measured and recorded before making the voluntary blood donation. Following Masimo brand portable device fingers SpHb value was measured.Then IVC diameter of patients in the supine position were measured using ultrasonography. Then he left to donors return in routine blood donation programme. A unit (500ml) of blood were drawn from each donor. After the blood donation process measured and recorded the vital signs again. SpHb was measured noninvasively from finger again. Following these measurements were recorded again by measuring the diameter of IVC.


Condition or disease
Blood Donors, Traumatic Blood Loss

Study Type : Observational
Actual Enrollment : 128 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison of Noninvasive Two Methods to Monitoring Blood Loss; Inferior Vena Cava (IVC) Ultrasound - Non-invasive Hemoglobin Measurement (SpHb)
Study Start Date : March 2016
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

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Group/Cohort
Prospective observational
The changes of IVC diameter, SpHb and vital signs of blood donors were observed after blood donation



Primary Outcome Measures :
  1. Diagnosis of stage 1 hemorrhagic shock [ Time Frame: 30 minute (15 minute blood donation, 15 minute rest time ). ]
    Changes in IVC diameter were observed with 500 ml blood loss. Measurement were made pre and post blood donation.

  2. Diagnosis of stage 1 hemorrhagic shock [ Time Frame: 30 minute (15 minute blood donation, 15 minute rest time ). ]
    Changes in SpHb were observed with 500 ml blood loss. Measurement were made pre and post blood donation.


Secondary Outcome Measures :
  1. Diagnosis of stage 1 hemorrhagic shock [ Time Frame: 30 minute (15 minute blood donation, 15 minute rest time ). ]
    Changes in Pulse rate were observed with 500 ml blood loss. Measurement were made pre and post blood donation.

  2. Diagnosis of stage 1 hemorrhagic shock [ Time Frame: 30 minute (15 minute blood donation, 15 minute rest time ). ]
    Changes in Arterial blood pressure were observed with 500 ml blood loss. Measurement were made pre and post blood donation.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Voluntary donors for blood donation.
Criteria

Inclusion Criteria:

  • Who have volunteered to donate blood
  • Older than 18 years
  • Both sexes

Exclusion Criteria:

  • Known tricuspid valve regurgitation and right heart failure
  • Oral intake or the fluid loss (diarrhea and vomiting-urination) between the two measurements during the blood donation
  • Inappropriate echogenicity for vena cava inferior diameter measurement

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02944851


Locations
Turkey
Haseki Training and Reseurch Hospital
Istanbul, Turkey, 34096
Sponsors and Collaborators
Haseki Training and Research Hospital
Investigators
Study Director: Adnan Yamanoğlu, MD The health ministry, Haseki Training and Research Hospital

Responsible Party: Adnan Yamanoğlu, Emergency medicine specialist, Emergency Department, Haseki Training and Research Hospital
ClinicalTrials.gov Identifier: NCT02944851     History of Changes
Other Study ID Numbers: 336
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018

Keywords provided by Adnan Yamanoğlu, Haseki Training and Research Hospital:
Blood donors
blood donation
traumatic blood loss
Trauma

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes