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Clinical Trials/NCT01372072
NCT01372072
Completed
Not Applicable

A Pilot Study to Investigate the Physiological and Clinical Effects of Heated Humidification During Non-Invasive Ventilation

Guy's and St Thomas' NHS Foundation Trust1 site in 1 country15 target enrollmentFebruary 1, 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease
Sponsor
Guy's and St Thomas' NHS Foundation Trust
Enrollment
15
Locations
1
Primary Endpoint
Adherence to NIV
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2012
End Date
September 30, 2014
Last Updated
4 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • psychiatric illness
  • pregnancy

Outcomes

Primary Outcomes

Adherence to NIV

Time Frame: up to 8 weeks

Study Sites (1)

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