None listed
Conditions
Brief summary
In the intensive care unit (ICU), non-invasive ventilation (NIV) is a treatment option for patients with respiratory failure. NIV involves the delivery of oxygenated air from a ventilator to the patient via a mask. The mask is secured to the patient’s head using straps that sit around the head to hold the mask over the nose and mouth. The purpose of NIV is to reduce the likelihood of invasive mechanical ventilation that requires the insertion of an artificial airway or breathing tube. Traditionally NIV masks cover the entire nose and mouth, resting on the nasal bridge. This can in rare instances lead to the development of pressure injuries on the bridge of the nose and as such facial disfiguration. At Sunshine hospital the Nivairo® mask is routinely used for NIV. This mask sits across the nasal bridge. In this study we would like to determine if the Visairo® mask that does not have a nasal bridge is equivalent to the Nivairo® mask for the delivery of NIV.
Interventions
The purpose of this study is to determine whether the bridge free Visairo® mask is as effective as the full face Nivairo® mask for the delivery of NIV (Non Invasive Ventilation). To do this we have designed a pragmatic randomised equivalence trial. The Visairo® is a new NIV mask and to date there is no evidence available to demonstrate how effective this mask is in the ‘real world’ clinical context. This trial will address that gap in the evidence.
This study is a single center study at Sunshin
The purpose of this study is to determine whether the bridge free Visairo® mask is as effective as the full face Nivairo® mask for the delivery of NIV (Non Invasive Ventilation). To do this we have designed a pragmatic randomised equivalence trial. The Visairo® is a new NIV mask and to date there is no evidence available to demonstrate how effective this mask is in the ‘real world’ clinical context. This trial will address that gap in the evidence. This study is a single center study at Sunshine Intensive Care Unit. A 13 bed ICU situated at Sunshine Hospital, Furlong Road, St Albans. Consecutive adult (> 18 years of age) patients admitted to the ICU who have not been mechanically ventilated during their admission, and require NIV for Type I Respiratory Failure, will be eligible for inclusion. They will be randomised to receive NIV using either the Nivairo® or Visairo® mask using permuted block randomisation with an allocation ratio of 1:1. Clinical ICU nurses and physiotherapists will administer the intervention. Eligible patients will receive either Nivairo or Visairo for 4 continuous hours unless the fit of the mask results in excessive leak. Anecdotal evidence indicates air leaks associated with Nivairo® use are rare. If air leaks are evident with the Visairo® and alternative mask size is not rectifying this usual practice would involve switching to the Nivairo®. This switch would generally occur within the first 15 to 30 minutes of NIV implementation. Protocol deviations will be captured in the REDCap survey completed at one hour post implementation and will also be documented in the patient’s progress notes and observation chart. The investigative team is comprised of clinicians (Equipment Nurse, Nurse Unit Manager, ICU Liaison Nurse, ICU Physiotherapist, ICU Nurse Specialists) who will provide 7-day a week oversight during the trial.
Sponsors
Sunshine Hosptial
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Consecutive adult patients admitted to the ICU that have not been mechanically ventilated during their admission and require NIV for Type 1 Respiratory Failure.
Exclusion criteria
<18 years of age Known history of dementia, claustrophobia, COPD with CO2 retention Active signs of delirium At risk of harming themselves of others due to mental illness or behavioral concerns Facial injuries Upper Airway Obstruction Impaired Neurological function (GCS <8) Ineffective gag Elevated ICP Pregnancy Previously intubated during their current ICU admission
Outcome results
None listed