A Study to Investigate the Effects of Heated Humidification During Non-Invasive Ventilation

Study Overview
=================
Brief Summary
-----------------
Noninvasive ventilation (NIV) is a form of ventilation delivered by a mask and is an important mode of treatment in patients with both acute and chronic respiratory (breathing) failure. Humidification is widely accepted as an essential part of the ventilation strategy in patients receiving invasive ventilation (i.e. via a tube inserted into the mouth), but its role during NIV use is not proven. Consequently, there is a variation in practice with regard to humidification during NIV. Humidification is important in maintaining upper and lower airway mucosal function and patients requiring NIV often report symptoms, such as throat dryness, due to a lack of airway humidity. Success of NIV in the acute setting is dependent on many factors including, patient tolerance of NIV during the acute phase. In patients with chronic obstructive airways disease (COPD), poor tolerance results in NIV failure, which necessitates endotracheal intubation or treatment failure. Furthermore, invasive ventilation increases the risk of a hospital acquired pneumonia, which is associated with a worse outcome. In the long term setting of NIV use, again patients frequently report symptoms due to drying of the airways and adherence to NIV can be highly variable. Adherence in these patients is important in improving both quality and length of life. Humidification devices may be technically effective, but clinicians have concerns regarding potential negative effects of these devices. There is a requirement to evaluate the use of humidification in both the acute and long term use of NIV, particular, in terms of patient ventilator interaction, which will impact on comfort and adherence to NIV. This will effect the overall effectiveness of ventilation. The investigators propose a randomised controlled trial to investigate the effects of a humidification system during noninvasive ventilation.

Official Title
-----------------
A Pilot Study to Investigate the Physiological and Clinical Effects of Heated Humidification During Non-Invasive Ventilation

Conditions
-----------------
Chronic Obstructive Pulmonary Disease, Chronic Respiratory Hypercapnic Failure, Neuromuscular Disease, Obesity Hypoventilation Syndrome

Intervention / Treatment
-----------------
* Device: non-invasive ventilation heated humidification (Fisher-Paykel MR810 and MR850 humidifiers)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hypercapnic respiratory failure age > 18 requiring non-invasive ventilation Exclusion Criteria: psychiatric illness pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Humidification<br>Patients in this arm of the trial will receive humidification with the non-invasive ventilation. | Device: non-invasive ventilation heated humidification (Fisher-Paykel MR810 and MR850 humidifiers)<br>* Heated humidification (Fisher-Paykel MR810 and MR850 humidifiers)<br>|
| No Intervention: NIV without humidifivation<br>As per usual practice patients in this arm will not have humidification with their NIV | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to NIV |  | up to 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic respiratory hypercapnic failure