A Study to Investigate the Effects of Heated Humidification During Non-Invasive Ventilation
Recruitment status was Not yet recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Chronic Obstructive Pulmonary Disease Chronic Respiratory Hypercapnic Failure Neuromuscular Disease Obesity Hypoventilation Syndrome |
Device: non-invasive ventilation heated humidification (Fisher-Paykel MR810 and MR850 humidifiers) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Pilot Study to Investigate the Physiological and Clinical Effects of Heated Humidification During Non-Invasive Ventilation |
- Adherence to NIV [ Time Frame: up to 8 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 16 |
| Study Start Date: | June 2011 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Humidification
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)
Heated humidification (Fisher-Paykel MR810 and MR850 humidifiers)
|
|
No Intervention: NIV without humidifivation
As per usual practice patients in this arm will not have humidification with their NIV
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- hypercapnic respiratory failure
- age > 18
- requiring non-invasive ventilation
Exclusion Criteria:
- psychiatric illness
- pregnancy
Contacts and Locations| United Kingdom | |
| St Thomas' Hospital | Not yet recruiting |
| London, United Kingdom | |
| Contact: Swapna Mandal 02071888070 swapna.mandal@gstt.nhs.uk | |
| Principal Investigator: | Swapna Mandal | Guy's and St Thomas' NHS Trust |
More Information
No publications provided
| Responsible Party: | Karen Ignatian, R&D department, Guy's and St Thomas' NHS Trust |
| ClinicalTrials.gov Identifier: | NCT01372072 History of Changes |
| Other Study ID Numbers: | RJ1 11/N141 |
| Study First Received: | June 9, 2011 |
| Last Updated: | June 10, 2011 |
| Health Authority: | United Kingdom: National Research Ethics Service Committee-Westminster |
Keywords provided by Guy's and St Thomas' NHS Foundation Trust:
|
chronic respiratory hypercapnic failure |
Additional relevant MeSH terms:
|
Hypercapnia Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Neuromuscular Diseases Obesity Obesity Hypoventilation Syndrome Hypoventilation Lung Diseases, Obstructive Signs and Symptoms, Respiratory Signs and Symptoms Respiratory Tract Diseases |
Nervous System Diseases Overnutrition Nutrition Disorders Overweight Body Weight Sleep Apnea, Obstructive Sleep Apnea Syndromes Apnea Respiratory Insufficiency Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders |
ClinicalTrials.gov processed this record on May 19, 2013