The DELVES Feasibility study
Research type
Research Study
Full title
Developing and Evaluating the Digitally Enhanced Liberation from VEntilation (DELVE) System - A Study of Feasibility and User Acceptance
IRAS ID
249143
Contact name
Charlotte Small
Contact email
Sponsor organisation
University Hospitals Birmingham NHS Foundation Trust
Duration of Study in the UK
0 years, 9 months, 1 days
Research summary
Some patients recovering from severe or critical illness on the Intensive Care Unit are treated with
mechanical ventilation. This supports the patients’ breathing, reducing effort required to breathe in
addition to providing extra oxygen if needed. Patients who have been very unwell, or need
mechanical ventilation for more than a few days, may become dependant on the support provided
and need training to breathe by themselves. This process is termed “weaning.” Patients usually
undergo a tracheostomy, a hole through the neck into the trachea (windpipe), which is more
comfortable than having the tube through the mouth. The sedation they need is then reduced and
they are woken up, as the support provided by the ventilator is slowly reduced. For some patients,
this process can take days or weeks, with complications and set backs. The process is often
uncomfortable, distressing and requires the resources of the intensive care unit, so it is important
to try to understand how we can make the weaning process as effective and quick as possible.
Current evidence suggests that we don’t yet understand many of the factors that influence the
success of weaning, but that a consistent approach is likely to be beneficial. Current systems used
to prescribe and monitor progress use different methods of documentation, including paper charts
and electronic records, which can be difficult to interpret. 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.REC name
Wales REC 6
REC reference
19/WA/0092
Date of REC Opinion
3 May 2019
REC opinion
Further Information Favourable Opinion