None listed
Conditions
Brief summary
This study will use a new Fisher and Paykel Healthcare flow generator that is capable of providing bi-level therapy in the pressure range 4 cmH2O to 30 cmH2O. The objective is to establish if patients who suffer from a chronic respiratory disease, that may be treated with bi-level, can determine a comfort preference between the FPH bi-level device and a commercially available bi-level device. Patients using the device will be awake and testing the device for comfort, attending a single visit lasting around 2-3 hours at the Medical Research Institute of NZ situated at Wellington Regional Hospital. They will undergo lung function testing to assess the capacity and function of their lungs. A small ear clip will be painlessly attached to record partial pressure of transcutaneous carbon dioxide (PtCO2), oxygen saturations and pulse rate. The study is to be setup such that patients will trial the FPH device and a state of the art bi-level device for 30 minutes each, in randomized order, with a washout period between devices. At the end of each session the patients will be asked a range of questions relating to comfort as well as being asked to complete a range of visual analog scales (VAS). Flow and pressure data will also be recorded in order to allow for off line analysis of ventilator synchrony and pressure delivery.
Interventions
The intervention Bi-level device is a new Fisher and Paykel Healthcare (FPH) bi-level device, administered for 30 minutes. Device mode will be set to bi-level Spontaneous/Timed (ST) mode. Humidity is not to be used. The device will be setup to provide the following as per the British Thoracic Society (BTS) guidelines:
• Inspiratory Positive Airways Pressure (IPAP) 15 cmH2O
• Expiratory Positive Airways Pressure (EPAP) 4 cmH2O
Note, British Thoracic Society guidelines recommend a starting EPAP
The intervention Bi-level device is a new Fisher and Paykel Healthcare (FPH) bi-level device, administered for 30 minutes. Device mode will be set to bi-level Spontaneous/Timed (ST) mode. Humidity is not to be used. The device will be setup to provide the following as per the British Thoracic Society (BTS) guidelines: • Inspiratory Positive Airways Pressure (IPAP) 15 cmH2O • Expiratory Positive Airways Pressure (EPAP) 4 cmH2O Note, British Thoracic Society guidelines recommend a starting EPAP of 3 cmH2O. 4 cmH2O will be used as an alternative as this is the lowest pressure the machine can provide. No supplemental oxygen is to be used with the device and no ramp function will be utilised. Advanced device setting will be set to the following • Rise time 200ms • Fall time 200ms • Triggering medium (6.0 lpm) • Backup rate 4 • Inspiratory Time 1 second The Non-invasive ventilation (NIV) mask will be sized according to the mask user instructions. The mask will be fitted to the participant and adjusted to minimise any leaks. The order of allocation of the 2 interventions will be randomised. During the rest period of at least 15 minutes after intervention 1, the participant will be asked to complete a questionnaire about their experience of each device. After intervention 2, the questionnaire will be repeated and trial completed with no further rest period required.
Sponsors
Fisher & Paykel Healthcare Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Aged 18+ • Patients diagnosed with chronic respiratory diseases associated with chronic respiratory failure
Exclusion criteria
• Significant hypoxia o StO2 < 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 o Current exacerbation requiring acute treatment with a short course of antibiotics/oral steroids within the last 1 week o Hospital 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
Outcome results
None listed