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The Use of the Fluid IV Alert Monitor to Decrease the Incidence of Undetected Empty IV Bag in Dimmed Operating Rooms

NCT02666027 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2018-07-19

No results posted yet for this study

Summary

This study is being performed to determine the effectiveness of Fluid Intravenous Alert (FIVA) in monitoring intravenous fluid delivered to patients under anesthesia in a dimmed ambient light in the operating room.

Conditions

  • Anesthesia

Interventions

DEVICE

Fluid Intravenous Alert (FIVA) 'on'

Fluid Intravenous Alert (FIVA) 'on' - The FIVA™ (EngenuityMED, Halifax, Canada) is a small, handheld, battery operated, device class I medical device in Canada (Figure 1). It is designed to alarm and alert the physician to change the IV bag when the fluid level in the chamber of the IV set is low. It also functions to stop the fluid flow through the gravity-fed tubing system when the alarm is triggered, preventing air from entering the IV tubing. We hypothesize that the FIVA would decrease the incidence of unnoticed dry IV bags during surgery, particularly when the operating room lights are dimmed and would therefore decrease the risks associated with undetected dry IV bags.

DEVICE

Fluid Intravenous Alert (FIVA) 'off'

The FIVA will be turned off. - The FIVA™ (EngenuityMED, Halifax, Canada) is a small, handheld, battery operated, device class I medical device in Canada. It is designed to alarm and alert the physician to change the IV bag when the fluid level in the chamber of the IV set is low. It also functions to stop the fluid flow through the gravity-fed tubing system when the alarm is triggered, preventing air from entering the IV tubing. We hypothesize that the FIVA would decrease the incidence of unnoticed dry IV bags during surgery, particularly when the operating room lights are dimmed and would therefore decrease the risks associated with undetected dry IV bags.

Sponsors & Collaborators

  • Nova Scotia Health Authority

    lead OTHER

Principal Investigators

  • Christian Lehmann, MD, PhD · Nova Scotia Health Authority

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2017-12-31
Completion
2017-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02666027 on ClinicalTrials.gov