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

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ClinicalTrials.gov Identifier: NCT01372072
Recruitment Status : Unknown
Verified March 2011 by Guy's and St Thomas' NHS Foundation Trust.
Recruitment status was:  Not yet recruiting
First Posted : June 13, 2011
Last Update Posted : June 13, 2011
Information provided by:
Guy's and St Thomas' NHS Foundation Trust

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
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  (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

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

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

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

Inclusion Criteria:

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

Exclusion Criteria:

  • psychiatric illness
  • pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01372072

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

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    Key Record Dates
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
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
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nutrition Disorders