REVERE Breathe : Version 1
Research type
Research Study
Full title
Feasibility of the use of Interactive Technology-enhanced Incentive Spirometry (InspireVR) to reduce post-operative pulmonary complications following elective oesophagectomy and total gastrectomy.
IRAS ID
213650
Contact name
Charlotte Small
Contact email
Sponsor organisation
University of Birmingham
Duration of Study in the UK
0 years, 5 months, 31 days
Research summary
Patients undergoing oesophagectomy or total gastrectomy are recommended to complete deep breathing exercises during their early recovery to reduce the risk of post-operative complications, such as lung infections. These exercises may include the use of a device called an incentive spirometer. The patient breathes in through the device as slowly and as deeply as possible, then holds his/her breath for three seconds. At present, these are non-electronic devices that do not record how well or how often the patient uses them, nor gives feedback as to how their lungs are performing.
REVERE Breathe is a pilot feasibility study evaluating the usability of a novel device called InspireVR. InspireVR has been developed using a human-centred design process to help patients undertake incentive spirometry. Commercial-off-the-shelf products have been combined with purpose-built software to produce an incentive spirometry-based “game”. InspireVR has been designed to remind patients to complete incentive spirometry, encourage them to perform the exercises correctly and record activity for their clinician to review.
The primary outcome for the study is the usability of InspireVR compared to the current non-electronic device, Spiroball. All patients undergoing elective oesophagectomy or total gastrectomy at Queen Elizabeth Hospital Birmingham and Heartlands Hospital will be eligible for recruitment to the trial, up to a total of 25 participants. Trial participation will occur during their postoperative admission to critical care, to a maximum of three days. The trial is being carried out to meet the requirements of the Medicines and Healthcare products Regulations Agency in order to apply for a CE mark as a class 1 medical device. This study will inform the development of a randomised controlled trial to evaluate the efficacy of post operative incentive spirometry on development of post-operative complications.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
16/WM/0458
Date of REC Opinion
6 Dec 2016
REC opinion
Further Information Favourable Opinion