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CompletedNCT01372072Updated Oct 8, 2021

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

An interventional study of non-invasive ventilation heated humidification (Fisher-Paykel MR810 and MR850 humidifiers) in Chronic Obstructive Pulmonary Disease, Chronic Respiratory Hypercapnic Failure and Neuromuscular Disease, sponsored by Guy's and St Thomas' NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2021-10-08.

Sponsored by Guy's and St Thomas' NHS Foundation Trust · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease
  • Chronic Respiratory Hypercapnic Failure
  • Neuromuscular Disease
  • Obesity Hypoventilation Syndrome

Keywords

  • chronic respiratory hypercapnic failure
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In context

Lung Diseases, Obstructive

2,591 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.

This study's enrollment of 15 is below the median of 66 across 1,837 interventional studies indexed under Lung Diseases, Obstructive.

Browse Lung Diseases, Obstructive studies →

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust is the lead sponsor of 284 studies on the registry; 79 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • psychiatric illness
  • pregnancy
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • 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)

  • No intervention
    NIV without humidifivation

    As per usual practice patients in this arm will not have humidification with their NIV

Interventions

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

    Heated humidification (Fisher-Paykel MR810 and MR850 humidifiers)

06

What researchers measure

Primary outcomes

  1. Adherence to NIV

    Time frame: up to 8 weeks

07

Study locations

1 site
  • St Thomas' Hospital
    London, United Kingdom
08

References and documents

Publications

  • Mandal S, Ramsay M, Suh ES, Harding R, Thompson A, Douiri A, Moxham J, Murphy PB, Hart N. External heated humidification during non-invasive ventilation set up: results from a pilot cross-over clinical trial. Eur Respir J. 2020 May 21;55(5):1901126. doi: 10.1183/13993003.01126-2019. Print 2020 May. No abstract available. PubMed 32366486 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 8, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01372072
Lead sponsor
Guy's and St Thomas' NHS Foundation Trust
Responsible party
Sponsor
First posted
Jun 13, 2011
Start date
Feb 1, 2012
Primary completion
Sep 30, 2014
Completion
Sep 30, 2014
Last update
Oct 8, 2021

Study contacts

Swapna Mandal
principal investigator · Guy's and St Thomas' NHS Trust

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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