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NCT Number: NCT01372072

A Study to Investigate the 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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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • psychiatric illness
  • pregnancy

Treatment and study plan

non-invasive ventilation heated humidification (Fisher-Paykel MR810 and MR850 humidifiers)

Device

Heated humidification (Fisher-Paykel MR810 and MR850 humidifiers)

Primary outcomes

  1. Adherence to NIV

    Time frame: up to 8 weeks

Sponsors and collaborators

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 13, 2011
Registry last updated
Oct 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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