Evaluation of Physiological Variables and Detection of Blood Loss in Healthy Adults With Different Subject Positioning by the CM-1500

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-28

Study Completion Date

2024-04-10

Brief Summary

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The study is a prospective, non-randomized, non-blinded, non-significant risk study enrolling up to 60 healthy adult subjects consented to undergo a 1-unit whole blood draw procedure. Subjects will wear the study device (CM-1500) while positioned in either a supine or reclined position during the blood draw and study-required physiological parameters will be captured pre-, during, and post-donation.

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Detailed Description

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Conditions

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Fluid Loss Blood Loss

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Supine Donation Position

Group Type EXPERIMENTAL

Whole blood donation supine

Intervention Type DEVICE

Subjects will undergo a 1-unit whole blood donation in a supine position

Reclined Donation Position

Group Type EXPERIMENTAL

Whole blood donation reclined

Intervention Type DEVICE

Subjects will undergo a 1-unit whole blood donation in a reclined position

Interventions

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Whole blood donation supine

Subjects will undergo a 1-unit whole blood donation in a supine position

Intervention Type DEVICE

Whole blood donation reclined

Subjects will undergo a 1-unit whole blood donation in a reclined position

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Ability to provide written informed consent
* Ability and willingness to comply with the study procedures and duration requirements
* 18 years of age or older
* Consented and eligible to undergo a single unit whole blood donation

Exclusion Criteria

* Females who are pregnant or breastfeeding
* Undergone an amputation of any upper extremity
* Diagnosed with dextrocardia
* Subjects who have a pacemaker
* Subjects with body hair density which prevents adequate application of device electrodes

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes