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

May 10, 2018 updated by: Adnan Yamanoğlu, Haseki Training and Research Hospital

Comparison of Noninvasive Two Methods to Monitoring Blood Loss; Inferior Vena Cava (IVC) Ultrasound - Non-invasive Hemoglobin Measurement (SpHb)

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

128

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34096
        • Haseki Training and Reseurch Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Voluntary donors for blood donation.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 minute (15 minute blood donation, 15 minute rest time ).
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.
30 minute (15 minute blood donation, 15 minute rest time ).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 minute (15 minute blood donation, 15 minute rest time ).
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.
30 minute (15 minute blood donation, 15 minute rest time ).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haseki Training and Research Hospital

Investigators

  • Study Director: Adnan Yamanoğlu, MD, The health ministry, Haseki Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

September 26, 2016

First Submitted That Met QC Criteria

October 25, 2016

First Posted (Estimate)

October 26, 2016

Study Record Updates

Last Update Posted (Actual)

May 16, 2018

Last Update Submitted That Met QC Criteria

May 10, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 336

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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