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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
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)	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	16 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Pilot Study to Investigate the Physiological and Clinical Effects of Heated Humidification During Non-Invasive Ventilation
Study Start Date :	June 2011
Estimated Primary Completion Date :	June 2012
Estimated Study Completion Date :	June 2012

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. Adherence to NIV [ Time Frame: up to 8 weeks ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• hypercapnic respiratory failure
• age > 18
• requiring non-invasive ventilation

Exclusion Criteria:

• psychiatric illness
• pregnancy

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United Kingdom
St Thomas' Hospital	Not yet recruiting
London, United Kingdom
Contact: Swapna Mandal 02071888070 swapna.mandal@gstt.nhs.uk

Sponsors and Collaborators

Guy's and St Thomas' NHS Foundation Trust

Investigators

Principal Investigator:	Swapna Mandal	Guy's and St Thomas' NHS Trust

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted:	June 13, 2011
Last Update Posted:	June 13, 2011
Last Verified:	March 2011

Keywords provided by Guy's and St Thomas' NHS Foundation Trust:

chronic respiratory hypercapnic failure

Additional relevant MeSH terms:

Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Neuromuscular Diseases; Hypoventilation; Hypercapnia; Obesity Hypoventilation Syndrome; Respiratory Tract Diseases; Nervous System Diseases; Respiratory Insufficiency; Respiration Disorders	Signs and Symptoms, Respiratory; Signs and Symptoms; Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Obesity; Overnutrition; Nutrition Disorders