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

Sponsor
Guy's and St Thomas' NHS Foundation Trust (Other)
Overall Status
Completed
CT.gov ID
NCT01372072
Collaborator
(none)
15
1
2
31.9
0.5

Study Details

Study Description

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 Phase
  • Device: non-invasive ventilation heated humidification (Fisher-Paykel MR810 and MR850 humidifiers)
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
Randomized
Intervention Model:
Crossover 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
Actual Study Start Date :
Feb 1, 2012
Actual Primary Completion Date :
Sep 30, 2014
Actual Study Completion Date :
Sep 30, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Adherence to NIV [up to 8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 St Thomas' Hospital London United Kingdom

Sponsors and Collaborators

  • Guy's and St Thomas' NHS Foundation Trust

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01372072
Other Study ID Numbers:
  • RJ1 11/N141
First Posted:
Jun 13, 2011
Last Update Posted:
Oct 8, 2021
Last Verified:
Sep 1, 2021

Study Results

No Results Posted as of Oct 8, 2021