Interactive technologies to enhance recovery and rehabilitation from major trauma and burns injury

Some patients recovering on the Intensive Care Unit are treated with mechanical ventilation and some may need training to breathe by themselves as they recover.

Milestone n:0%

What does each milestone mean?

1 = Clinical need
2 = Idea
3 = Proof of concept
4 = Proof of feasibility
5 = Proof of value
6 = Initial clinical trials
7 = Validation of solution
8 = Approval and launch
9 = Clinical use
10 = Standard of care

Aim

The project aims are to:

Evaluate the safety, usability, user acceptance and usage errors of the DELVE system by staff on the ICU.
Determine the feasibility of using the DELVE system to prescribe ventilatory support throughout the process of liberation from mechanical ventilation.
Determine the feasibility of using the DELVE system to display the patients’ progress, in terms of ventilation mode, level of support, and respiratory parameters, during liberation from mechanical ventilation.
Determine the feasibility of using the DELVE system to store data to allow individual or cohort analysis, including reliability and stability of the DELVE system.

Lay Summary

Some patients recovering on the Intensive Care Unit are treated with mechanical ventilation and some may need training to breathe by themselves as they recover. This process is termed “weaning”. It is important to try to understand how we can make the weaning process as efficient as possible. We don’t yet understand many of the factors that influence the success of weaning. A new device has been developed, the “Digitally Enhanced Liberation from VEntilation” or “DELVE” system which has been designed to improve the clinical team’s ability to prescribe the weaning plan, and interpret the patients’ progress. The DELVE system will also collect data which will help us to better understand some of the factors that influence rate of weaning. This trial is a feasibility study of this novel device in the ICU setting, to include evaluation of user acceptance, prior to a future definitive trial of effectiveness.

Background

Some ICU patients require prolonged mechanical ventilation. The process of liberating a patient from mechanical ventilation is termed “weaning”. Like many aspects of physical training, there is no universally accepted formula for weaning and it is part of the overall rehabilitation process in ICU. To best understand the factors affecting the weaning process for patients, it is first and foremost necessary to ensure that weaning-associated data, including ventilatory support and respiratory pattern parameters, supported by information illustrating decision-making processes, are recorded accurately and are easy to interpret. It is proposed that a prototype electronic version of the paper weaning chart, termed the “Digitally Enhanced Liberation from VEntilation” or “DELVE” system could allow clinical prescription of the weaning plan and an accurate record of patient performance and adherence to the weaning plan.

Method

This is feasibility study will collect data to support the development of a future clinical trial. This study will be a mixed-methods feasibility study of the introduction of the DELVE system to the ICU over a 9 month period. Quantitative data collection on patient recruitment and device usage will be supported by qualitative methods to assess user acceptance and experience, where the users are members of the multidisciplinary clinical team on the ICU. This study follows the guidance on developing and evaluating complex interventions provided by the Medical Research Council. During the study, the DELVE system will be used in parallel with standard care, including the paper-based “Weaning Chart” and patient records. This study will directly compare the usability, benefits and potential limitations of the DELVE system compared to current practice of weaning prescription and record of progress.