Comfort comparison of two bi-level devices in patients with chronic respiratory diseases.
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)chronic respiratory diseasesRespiratory - Other respiratory disorders / diseasesRespiratory - Chronic obstructive pulmonary disease
- Registration Number
- ACTRN12617001600336
- Lead Sponsor
- Fisher & Paykel Healthcare Ltd
- Brief Summary
The comfort of a device in treating respiratory failure is critical to ensure compliance and effective treatment times. The ideal ventilatory support device in respiratory failure may be one that can deliver both Non-Invasive Ventilation (NIV) and Nasal High Flow (NHF) therapy and be easily switched between the 2 modes, depending on the clinical scenario and patient preference. This study was a preliminary investigation of an NHF device that is also capable of using the internal flow generator to provide NIV through bi-level pressure support. This dual NHF/NIV device can easily switch between the two therapy modes - possibly the ideal application for NHF therapy, making it a practical application for hospital ward-based therapy. We compared the NIV function of this NHF/NIV device against a standard Resmed NIV device. Comfort scores showed no significant difference between the standard Resmed NIV device and NHF/NIV device in this randomised controlled cross-over study in patients with chronic respiratory diseases at risk of hypercapnic respiratory failure. The NHF/NIV device has been shown to trigger satisfactorily and produced similar clinical effects to the Resmed device while overall more patients preferred its use.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
•Aged 18+
•Patients diagnosed with chronic respiratory diseases associated with chronic respiratory failure
•Significant hypoxia
oStO2 < 88 % after 20-30 minutes of Sentec stabilisation or for a sustained period during the intervention (according to investigators clinical discretion)
•Chronic respiratory disease that is not deemed to be stable
oCurrent exacerbation requiring acute treatment with a short course of antibiotics/oral steroids within the last 1 week
oHospital admission for an acute exacerbation in the last 2 weeks
•Recent cardiac or respiratory arrest
•Gastro intestinal bleeding, ileus or recent gastrointestinal surgery
•Coma, decreased level of consciousness or agitation
•Anatomical or subjective difficulty with airway access e.g. facial surgery, trauma, vomiting upper airway obstruction
•Cerebrospinal fluid leak, abnormalities of the cribriform plate or prior history of head trauma.
•Use of supplemental oxygen
•Fluid depletion, poor left ventricular function or cardiac disease without adequate pharmacological therapy
•Pneumothorax, or at high clinical risk of pneumothorax or barotrauma due to, for example, previous pneumothorax, pneumomediastinum, severe bullous lung disease, acute lung injury secondary to pneumonia, interstitial lung diseases, cystic fibrosis and neuromuscular disease
•Diagnosis of a notifiable disease
•Use of an implantable medical device
•Have any other condition which, at the investigator’s discretion, is believed may present a safety risk or impact the feasibility of the study or the study results
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Difference in 'global tolerability score' found by averaging four comfort scores ie the answers to four questions, as assessed by participants on a Visual Analogue Scale (VAS). The four questions refer to: 1) overall comfort, 2) overall breathing/pressure change synchrony 3) pressure comfort on inspiration 4) pressure comfort on expiration, The VAS is a continuous 100mm scale with 0 being the most negative” and 100 being the most positive”.[30 minutes]
- Secondary Outcome Measures
Name Time Method