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REVERE Breathe

Feasibility of the use of Interactive Technology-enhanced Incentive Spirometry (InspireVR) to reduce post-operative pulmonary complications following elective oesophagectomy and total gastrectomy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN14521547
Enrollment
25
Registered
2017-04-24
Start date
2017-04-03
Completion date
Unknown
Last updated
2017-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Specialty: Critical care, Primary sub-specialty: Critical Care

Interventions

The intervention under investigation is an interactive technology-enhanced incentive spirometry, via a device named InspireVR. This novel device will consist of a mouthpiece, though which the patient
the signal from which will be converted a novel, bespoke game via purpose built “midware”. The game will be presented on a touch-screen display device (Windows Notebook), which will be incorporated in

Sponsors

University of Birmingham
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patient Inclusion criteria: 1. All consecutive patients undergoing elective oesophagectomy and total gastrectomy for cancer treatment on their first post-operative admission to the critical care units (intensive care or high dependency units) at QEHB or BHH 2. Age 18 years and over 3. All genders Staff Inclusion criteria All clinical, nursing and physiotherapy staff who have had direct care responsibilities for patients participating in the trial will be invited to participate in the focus groups during the study. Physiotherapists, nursing staff and doctors allocated to care for participants will be identified during the intervention days of the study and approached by the research team.

Exclusion criteria

Exclusion criteria: 1. Patient refusal 2. Cognitive impairment preventing patient cooperation with breathing exercises 3. Severe visual impairment, such that the patient is unable to visualise the computer display 4. Post-operative complications necessitating placement of tracheostomy

Design outcomes

Primary

MeasureTime frame
Successful patient usage of the InspireVR. Usage will be defined as the total number of successful attempts (patient able to record a MIC breath) using InspireVR compared with number of successful attempts when using Spiroball (as reported by the patient). Feasibility of the device will be established if the number of successful attempts at incentive spirometry during InspireVR use is equal to or higher than the number of patient-reported successful uses of the Spiroball device. InpsireVR usage will be collected via the device software. Use of Spiroball will be reported by the patient and bedside staff using a paper log.

Secondary

MeasureTime frame
1. User (patients) acceptance and experience of the InspireVR device is assessed using a 10 item likert scale, based on the validated System Usability Scale on day 3-4 of trial, following completion of intervention 2. User (physiotherapists and nurses) acceptance and experience of the InspireVR device is assessed using a 10 item likert scale, based on the validated System Usability Scale (Focus group during trial period) 3. Compliance with incentive spirometry. Each session will be recorded by embedded software within the InspireVR device. Use of the Spiroball will recorded by the patient and on the patient nursing records (current standard practice) daily during intervention. 4. Patient achievement of prespecified targets for MIC on the InspireVR is assessed via InspireVR software daily during intervention 5. Side effects and adverse events whilst using the InspireVR device are collected daily during intervention 6. Pain and discomfort experience during use of InspireVR and Spiroball is assessed using a 0-3 Verbal rating scale at each IS session 7. Therapist/clinical staff (doctor/nurse/physiotherapist) user acceptance and experience is assessed through semi structured interviews and free text comments during the trial period 8. Post-operative pulmonary complications (PPCs) as defined by the PROVE network investigators is collected routinely 9. All cause 30 day morbidity (Clavien-Dindo classification) 10. Critical Care Unit length of stay 11. Hospital length of stay 12. In hospital mortality 13. All cause 30 day mortality

Countries

United Kingdom

Contacts

Public ContactCharlotte Small
charlotte.small@uhb.nhs.uk+44 7974 001858

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026