A randomised, parallel controlled trial on the effect of heated humidification on patient comfort and facial temperature in patients on non-invasive ventilation, using an oro-nasal facemask.

Effects of heated humidification during non-invasive ventilation on patient comfort with acute exacerbations of Chronic Obstructive Pulmonary Disease (COPD) and Obesity Hypoventilation Syndrome (OHS).

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611001040954

Enrollment

Registered

2011-10-04

Start date

2011-08-22

Completion date

2012-07-20

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

Non-invasive ventilation (NIV) provides respiratory support through the patient’s upper airway using a facemask. NIV is beneficial for some patients, such as those with an exacerbation of chronic obstructive pulmonary disease (COPD), or obesity hyperventilation syndrome (OHS). Many patients find NIV therapy uncomfortable and difficult to tolerate due to the high pressures and flows of cold gas. Consequently, the success of NIV, and ultimately patient outcome, can be influenced by how much a patient uses it. To improve patient tolerance the gas supplied during NIV may be heated and humidified to 31degrees C/ 32mg/L water, although there is little clinical data to support this for this therapy. Patient tolerance is improved because heating and humidifying the gas minimises airway drying and improves secretion clearance from the patient’s airways, stopping them from becoming dry and sore and making it easier for them to cough up secretions. However, some patients complain of being too hot on NIV and using heated humidification may contribute to this. We will test patient comfort, perception of heat, and facial temperature, related to core body temperature, during NIV with and without heated humidification. We will assess the benefits to patients of supplying heated humidification with this therapy. This study will take place exclusively in the respiratory ward (ward 7) of Middlemore Hospital. Only patients already prescribed NIV by a respiratory physician will be eligible for the study. Patients are given up to 24 hours to stabilise on NIV, once they are stable on NIV they are asked if they want to take part in the study. After the study patients will continue on NIV as prescribed by the respiratory physician. They may stay on the study equipment or use the standard hospital NIV equipment, which they will have been on prior to being recruited on to the study.

Interventions

Treatment: Heated humidifier and heated respiratory circuit A controlled, parallel study. Patients already prescribed non-invasive ventilation (NIV) are randomised to 2 arms; humidified and non-humidified NIV. Patients are given up to 24 hours to stabilise on NIV, once they are stable on NIV they are asked if they want to take part in the study. Patients in the humidified arm receive 4 hours of NIV, delivered from a standard hospital NIV ventilator, using the study heated humidifier, heated circuit and mask. The humidifier is turned off and does not contain any water as a washout, to establish a baseline. After 4 hours water is added to the heated humidifier and it is switched on and remains on for the following 8 hour treatment. In this intervention group the gas is heated and humidified to 31 degrees C, 32mg/L water. Patients in the non-humidified arm receive 4 hours of NIV, delivered from a standard hospital NIV ventilator, using the study heated humidifier, heated circuit and mask. The humidifier is turned off and does not contain any water as a washout, to establish a baseline. The humidifier remains switched off with no water in it for the 12 hours of the study, 4 hour washout and 8 hours treatment.

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

Inclusion criteria

1. Acute ventilatory failure in patients with Chronic Obstructive Pulmonary Disease (COPD) or Obesity Hypoventilation Syndrome (OHS), or overlap syndrome (COPD and OHS) 2. NIV has been commenced on clinical grounds, in consultation with a Respiratory Physician 3. The patient has shown an initial positive clinical response to NIV 4. Patient has a good understanding of English 5. Patient is capable of giving informed consent

Exclusion criteria

1. NIV is medically contraindicated 2. Delirium, dementia or confusion due to any cause 3. Patients considered as palliative 4. Kyphoscoliosis 5. Neuromuscular disease 6. Motor neuron disease 7. Cardiogenic pulmonary oedema 8. Unstable coronary disease 9. Facial deformity 10. Pneumothorax 11. NIV failure in the first hour (either intolerance or requirement for intubation) 12. Patient previously enrolled in the study

Outcome results