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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Guy's and St Thomas' NHS Foundation Trust.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01372072
First received: June 9, 2011
Last updated: June 10, 2011
Last verified: March 2011

June 9, 2011
June 10, 2011
June 2011
June 2012   (final data collection date for primary outcome measure)
Adherence to NIV [ Time Frame: up to 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01372072 on ClinicalTrials.gov Archive Site
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A Study to Investigate the Effects of Heated Humidification During Non-Invasive Ventilation
A Pilot Study to Investigate the Physiological and Clinical Effects of Heated Humidification During Non-Invasive Ventilation

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.

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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: 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)
Heated humidification (Fisher-Paykel MR810 and MR850 humidifiers)
  • Active Comparator: Humidification
    Patients in this arm of the trial will receive humidification with the non-invasive ventilation.
    Intervention: Device: non-invasive ventilation 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
16
June 2012
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • psychiatric illness
  • pregnancy
Both
18 Years and older
No
United Kingdom
 
NCT01372072
RJ1 11/N141
No
Karen Ignatian, R&D department, Guy's and St Thomas' NHS Trust
Guy's and St Thomas' NHS Foundation Trust
Not Provided
Principal Investigator: Swapna Mandal Guy's and St Thomas' NHS Trust
Guy's and St Thomas' NHS Foundation Trust
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP