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OpenTrials
Completed

NCT Number: NCT02553421

Optical Detection of Intravenous Infiltration:A Pilot Study

This study will examine the use of the ivWatch Model 400 to monitor PIV sites in pediatric patients. Half the participants will be monitored by the device without infiltration notifications and the other half will be monitored by the device with infiltration notifications enabled.

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Key information

Conditions

Infiltration of Peripheral IV Therapy

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Signed consent and/or assent
  • Newborn to 17 years of age
  • Weight > 2.5 kg

Exclusion criteria

  • Severe skin integrity issues such as severe eczema, burns, epidermolysis bullosa, rash, hives
  • Severe scarring of tissue (excessive IV use)
  • Tattoo in area of PIV site
  • IV site located in antecubital fossa

Treatment and study plan

ivWatch Model 400

Device

The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses.

Primary outcomes

  1. Time Infiltration Detected by Nurse

    Time frame: Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 week

    The difference in time to detection between the clinician and the ivWatch device is measured from the non-alarming group. This measurement reveals how much earlier the infiltration could have been detected by the ivWatch device compared to the clinician assessments. This metric is measured using the patients in the non-alarming group since an infiltration notification by the ivWatch device could bias the clinician's diagnosis.

  2. Infiltration Sensitivity

    Time frame: Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 week

    The infiltration sensitivity is defined as the percentage of the clinician-confirmed infiltrations that are detected by the ivWatch device before the clinician's diagnosis. This metric is measured and reported separately for non-alarming and alarming groups, since an infiltration notification by the ivWatch device could bias the clinician's diagnosis.

  3. Notification Rate of ivWatch Device

    Time frame: Participants will be followed for the duration of intravenous therapy, an expected duration of up to 1 week

    The notification rate is defined as the number of ivWatch device infiltration notifications issued in a certain amount of time, typically reported in units of notifications per day. The notification rate is the number of notifications per day, excluding cases with clinician confirmed infiltrations. This metric is measured using the subjects in the alarming group since the number of notifications could potentially depend on how quickly nurses reset the device.

Sponsors and collaborators

Lead sponsor

ivWatch, LLC

Industry

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 17, 2015
Registry last updated
Apr 6, 2017

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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