Chronic Obstructive Pulmonary DiseaseNCT01372072
A Study to Investigate the Effects of Heated Humidification During Non-Invasive Ventilation
A study testing non-invasive ventilation heated humidification (Fisher-Paykel MR810 and MR850 humidifiers) in people with Chronic Obstructive Pulmonary Disease and Chronic Respiratory Hypercapnic Failure, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Chronic Respiratory Hypercapnic Failure, Neuromuscular Disease
- What is being tested?
- non-invasive ventilation heated humidification (Fisher-Paykel MR810 and MR850 humidifiers)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2012to 30 Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hypercapnic respiratory failure
- age > 18
- requiring non-invasive ventilation
Who cannot join
- psychiatric illness
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Investigate the Physiological and Clinical 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.
- Conditions
- Chronic Obstructive Pulmonary Disease, Chronic Respiratory Hypercapnic Failure, Neuromuscular Disease, Obesity Hypoventilation Syndrome
- Being tested
- non-invasive ventilation heated humidification (Fisher-Paykel MR810 and MR850 humidifiers)
- Keywords
- chronic respiratory hypercapnic failure
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Neuromuscular Diseases, Obesity Hypoventilation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive ventilation heated humidification (Fisher-Paykel MR810 and MR850 humidifiers)Device
Heated humidification (Fisher-Paykel MR810 and MR850 humidifiers)
| Study group | Role | What they receive |
|---|---|---|
| Humidification | Active comparator | Patients in this arm of the trial will receive humidification with the non-invasive ventilation. Receives: Device: non-invasive ventilation heated humidification (Fisher-Paykel MR810 and MR850 humidifiers) |
| NIV without humidifivation | No intervention | As per usual practice patients in this arm will not have humidification with their NIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to NIV
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2011 (estimated)
- Study start1 Feb 2012
- Primary completion30 Sep 2014
- Study completion30 Sep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Swapna Mandal, Principal investigator, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01372072
- Sponsor's protocol ID
- RJ1 11/N141
- Status last verified
- Sep 2021
- First submitted
- 9 Jun 2011
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Investigate the Physiological and Clinical Effects of Heated Humidification During Non-Invasive Ventilation
- ClinicalTrials.gov ID
- NCT01372072
- Acronym / sponsor ID
- RJ1 11/N141
- Conditions
- Chronic Obstructive Pulmonary Disease, Chronic Respiratory Hypercapnic Failure, Neuromuscular Disease, Obesity Hypoventilation Syndrome
- Keywords
- chronic respiratory hypercapnic failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Feb 2012 (actual)
- Primary completion
- 30 Sep 2014 (actual)
- Study completion
- 30 Sep 2014 (actual)
- First posted
- 13 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Humidification | Active comparator | Device: non-invasive ventilation heated humidification (Fisher-Paykel MR810 and MR850 humidifiers)Patients in this arm of the trial will receive humidification with the non-invasive ventilation. |
| NIV without humidifivation | No intervention | –As per usual practice patients in this arm will not have humidification with their NIV |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- hypercapnic respiratory failure
- age > 18
- requiring non-invasive ventilation
Key exclusion criteria (2 listed)
- psychiatric illness
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-invasive ventilation heated humidification (Fisher-Paykel MR810 and MR850 humidifiers)Heated humidification (Fisher-Paykel MR810 and MR850 humidifiers) | Device | Humidification |
Primary outcome
Adherence to NIV
Time frame: up to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
- Derived from this study: PubMed 32366486Mandal 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Swapna Mandal principal investigator
Guy's and St Thomas' NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-invasive ventilation heated humidification (Fisher-Paykel MR810 and MR850 humidifiers) in people with Chronic Obstructive Pulmonary Disease and Chronic Respiratory Hypercapnic Failure, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to NIV (time frame: up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01372072, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2021.