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

Primary Purpose

Chronic Obstructive Pulmonary Disease, Chronic Respiratory Hypercapnic Failure, Neuromuscular Disease

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
non-invasive ventilation heated humidification (Fisher-Paykel MR810 and MR850 humidifiers)
Sponsored by
Guy's and St Thomas' NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring chronic respiratory hypercapnic failure

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • psychiatric illness
  • pregnancy

Sites / Locations

  • St Thomas' Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Humidification

NIV without humidifivation

Arm Description

Patients in this arm of the trial will receive humidification with the non-invasive ventilation.

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

Outcomes

Primary Outcome Measures

Adherence to NIV

Secondary Outcome Measures

Full Information

First Posted
June 9, 2011
Last Updated
September 30, 2021
Sponsor
Guy's and St Thomas' NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT01372072
Brief Title
A Study to Investigate the Effects of Heated Humidification During Non-Invasive Ventilation
Official Title
A Pilot Study to Investigate the Physiological and Clinical Effects of Heated Humidification During Non-Invasive Ventilation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2012 (Actual)
Primary Completion Date
September 30, 2014 (Actual)
Study Completion Date
September 30, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guy's and St Thomas' NHS Foundation Trust

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Chronic Respiratory Hypercapnic Failure, Neuromuscular Disease, Obesity Hypoventilation Syndrome
Keywords
chronic respiratory hypercapnic failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Humidification
Arm Type
Active Comparator
Arm Description
Patients in this arm of the trial will receive humidification with the non-invasive ventilation.
Arm Title
NIV without humidifivation
Arm Type
No Intervention
Arm Description
As per usual practice patients in this arm will not have humidification with their NIV
Intervention Type
Device
Intervention Name(s)
non-invasive ventilation heated humidification (Fisher-Paykel MR810 and MR850 humidifiers)
Intervention Description
Heated humidification (Fisher-Paykel MR810 and MR850 humidifiers)
Primary Outcome Measure Information:
Title
Adherence to NIV
Time Frame
up to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: hypercapnic respiratory failure age > 18 requiring non-invasive ventilation Exclusion Criteria: psychiatric illness pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Swapna Mandal
Organizational Affiliation
Guy's and St Thomas' NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Thomas' Hospital
City
London
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
32366486
Citation
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.
Results Reference
derived

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

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