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

NCT02666027 | Completed

• 1 other identifier: NSHA REB ROMEO File#: 1019905
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Fluid monitoring

Outcome Measures

Primary Outcomes (1)

• Incidence of undetected dry IV bags

  For the duration of the surgery

Secondary Outcomes (7)

• Type of surgical procedure

  Baseline

• Duration of surgical procedure

  Baseline

• Presence of air in the IV

  For the duration of surgery

• Number of false alarms triggered by the FIVA device during the procedure

  For the duration of surgery

• VAS assessment of ease of use of the FIVA

  For the duration of surgery

Study Arms (2)

FIVA ON

EXPERIMENTAL

The FIVA will be turned on for cases randomized to an even number. The ON light will be covered by tape. Routine induction and maintenance of anesthesia and rate and manner of delivery of IV fluid will be administered at the discretion by the anesthesiologist. The FIVA monitor will only monitor the first IV fluid bag since the study will be unblinded once the FIVA monitor alarm is triggered. When the IV bag is empty and the FIVA alarm is triggered, the anesthesiologist will turn off the FIVA and change the IV bag. The following will be recorded by the anesthesiologist: Type of surgical procedure; Duration of surgery; Presence of air in the IV; Number of false alarms triggered by the FIVA during the procedure; VAS assessment of ease of use of the FIVA; Loudness of audial alarm of the FIVA.

Device: Fluid Intravenous Alert (FIVA) 'on'

FIVA OFF

PLACEBO COMPARATOR

The FIVA will be off for cases randomized to odd numbers. The indicator lights will be covered by tape. Routine induction and maintenance of anesthesia and rate/manner of delivery of IV fluid will be administered at the discretion of the anesthesiologist. The IV bag may run dry with or without being noticed by the anesthesiologist. When they detect the empty bag, it will be changed after the removal of the FIVA. The anesthesiologist will record the presence or absence of air in the IV tubing following the termination of the study. The following will be recorded by the anesthesiologist: Type of surgery; Duration of surgery; Presence of air in the IV; Number of false alarms triggered by the FIVA device; VAS assessment of ease of use of the FIVA; Assessment of audial alarm of the FIVA.

Device: Fluid Intravenous Alert (FIVA) 'off'

Interventions

Fluid Intravenous Alert (FIVA) 'on' DEVICE

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.

FIVA ON

Fluid Intravenous Alert (FIVA) 'off' DEVICE

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.

FIVA OFF

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Attending anesthesiologists scheduled for elective surgical procedures at the Queen Elizabeth II Health Sciences Centre (QEII).

You may not qualify if:

• Attending anesthesiologists scheduled for elective surgical procedures at the QEII with cases where lights to not dimmed.

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Related Publications (6)

• Janakan G, Ellis H. Dr Thomas Aitchison Latta (c1796-1833): pioneer of intravenous fluid replacement in the treatment of cholera. J Med Biogr. 2013 May;21(2):70-4. doi: 10.1258/jmb.2012.012004.

  PMID: 24585745 BACKGROUND

• Matern U, Koneczny S. Safety, hazards and ergonomics in the operating room. Surg Endosc. 2007 Nov;21(11):1965-9. doi: 10.1007/s00464-007-9396-4. Epub 2007 May 5.

  PMID: 17483989 BACKGROUND

• Hung OR, Comeau. L. Incidence of intra-operative cessation of intravenous (iv) fluid administration. Can J Anesth 1998;45:A5.

  BACKGROUND

• Mendenhall ML, Spain DA. Venous air embolism and pressure infusion devices. J Trauma. 2007 Jul;63(1):246. doi: 10.1097/01.ta.0000210439.64958.df. No abstract available.

  PMID: 17622901 BACKGROUND

• Mirski MA, Lele AV, Fitzsimmons L, Toung TJ. Diagnosis and treatment of vascular air embolism. Anesthesiology. 2007 Jan;106(1):164-77. doi: 10.1097/00000542-200701000-00026.

  PMID: 17197859 BACKGROUND

• Pant D, Narani KK, Sood J. Significant air embolism: A possibility even with collapsible intravenous fluid containers when used with rapid infuser system. Indian J Anaesth. 2010 Jan;54(1):49-51. doi: 10.4103/0019-5049.60498.

  PMID: 20532073 BACKGROUND

Study Officials

• Christian Lehmann, MD, PhD

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, FRCPC

Study Record Dates

• First Submitted: November 5, 2015
• First Posted: January 28, 2016
• Study Start: January 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: July 19, 2018

Record last verified: 2018-07