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

Blood Donors, Traumatic Blood Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02944851
• Other study ID #: 336
• Status: Completed
• Start date: March 2016
• Est. completion date: September 2016

Study information

• Verified date: May 2018
• Source: Haseki Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Donors, Traumatic Blood Loss
• Hemorrhage

Locations

Country	Name	City	State
Turkey	Haseki Training and Reseurch Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Haseki Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis of stage 1 hemorrhagic shock	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 ).
Primary	Diagnosis of stage 1 hemorrhagic shock	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	Diagnosis of stage 1 hemorrhagic shock	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 ).
Secondary	Diagnosis of stage 1 hemorrhagic shock	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 ).