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Completed

NCT Number: NCT02944851

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

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.

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Key information

Conditions

Blood Donors, Traumatic Blood Loss Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Haseki Training and Reseurch Hospital

Istanbul, 34096, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Haseki Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Oct 26, 2016
Registry last updated
May 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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