Evaluation of Clinical Tool to Improve Adherence to Ventilator Management

NCT05626699 | Unknown DMC

• 2 other identifiers: RTA II-015R44HL146012-03
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Respiratory Therapists (RTs) have difficulty maintaining compliance with protocols and making efficient handoff communication. This project will evaluate the effectiveness of an electronic tool that will display a dashboard of key information on all the RTs patients and provide reminders that indicate whether evidence-based practice protocols are being followed. In addition, it will collect data from medical devices and the EMR and outline key information in the appropriate format to help standardize and improve handoff communication. The study will first collect blind baseline data for comparison with protocol adherence and silently evaluate shift change handoffs. In the second stage, the electronic tool will be installed and used to evaluate whether protocol compliance and shift change handoff is improved.

Conditions

Respiratory Therapy

Outcome Measures

Primary Outcomes (1)

• Respiratory Therapist Likert Scale Questionnaire

  Questionnaire

  through study completion, an average of 60 days

Study Arms (1)

RT's in ICU

OTHER

We will collect ventilator pressure, flow, volume, oxygen and breathing pattern data, etc, as well as arterial blood-gas exchange and hemodynamic data of adults attached to ventilators. the RRT's will treat patients as normal without the assistance of the RT Assistant for the pre-intervention phase and will be observed collecting the same data and performing patient care with the assistance of the RT Assistant during the intervention phase. The RRTs will then be given a likert scale questionnaire on the use of the RT Assistant.

Device: RT Assistant

Interventions

RT Assistant DEVICE

RRT's will be given the RT Assistant to use during a regular ICU shift to make patient care decisions.

RT's in ICU

Eligibility Criteria

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

You may qualify if:

• Practicing RTs are eligible to participate in this study

You may not qualify if:

• non-RTs or those who refuse to participate

Sponsors & Collaborators

• Convergent Engineering, Inc.: lead
• University of Florida: collaborator
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Officials

• Philip Efron, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neil Euliano, PhD

CONTACT

3523784899; neil@conveng.com

Danay Harvey

CONTACT

3523784899; dharvey@conveng.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: RTs will be observed during patient care without the use of the RT Assistant during the non-interventional phase and with the use of the RT Assistant during the interventional phase. RTs will be observed by highly trained RTs during both phases. RTs will answer a likert scale questionnaire about the use of the RT Assistant used to make clinical decisions.

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: November 25, 2022
• Study Start: January 31, 2024
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share