A Study to Investigate the Effects of Heated Humidification During Non-Invasive Ventilation
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ClinicalTrials.gov Identifier: NCT01372072 |
Recruitment Status
: Unknown
Verified March 2011 by Guy's and St Thomas' NHS Foundation Trust.
Recruitment status was: Not yet recruiting
First Posted
: June 13, 2011
Last Update Posted
: June 13, 2011
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Condition or disease | Intervention/treatment | Phase |
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Chronic Obstructive Pulmonary Disease Chronic Respiratory Hypercapnic Failure Neuromuscular Disease Obesity Hypoventilation Syndrome | Device: non-invasive ventilation heated humidification (Fisher-Paykel MR810 and MR850 humidifiers) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 16 participants |
Allocation: | Randomized |
Intervention Model: | Parallel 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 |
Study Start Date : | June 2011 |
Estimated Primary Completion Date : | June 2012 |
Estimated Study Completion Date : | June 2012 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Humidification
Patients in this arm of the trial will receive humidification with the non-invasive ventilation.
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Device: non-invasive ventilation heated humidification (Fisher-Paykel MR810 and MR850 humidifiers)
Heated humidification (Fisher-Paykel MR810 and MR850 humidifiers)
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No Intervention: NIV without humidifivation
As per usual practice patients in this arm will not have humidification with their NIV
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- Adherence to NIV [ Time Frame: up to 8 weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01372072
United Kingdom | |
St Thomas' Hospital | Not yet recruiting |
London, United Kingdom | |
Contact: Swapna Mandal 02071888070 swapna.mandal@gstt.nhs.uk |
Principal Investigator: | Swapna Mandal | Guy's and St Thomas' NHS Trust |
Responsible Party: | Karen Ignatian, R&D department, Guy's and St Thomas' NHS Trust |
ClinicalTrials.gov Identifier: | NCT01372072 History of Changes |
Other Study ID Numbers: |
RJ1 11/N141 |
First Posted: | June 13, 2011 Key Record Dates |
Last Update Posted: | June 13, 2011 |
Last Verified: | March 2011 |
Keywords provided by Guy's and St Thomas' NHS Foundation Trust:
chronic respiratory hypercapnic failure |
Additional relevant MeSH terms:
Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Neuromuscular Diseases Hypoventilation Hypercapnia Obesity Hypoventilation Syndrome Respiratory Tract Diseases Nervous System Diseases Respiratory Insufficiency Respiration Disorders |
Signs and Symptoms, Respiratory Signs and Symptoms Sleep Apnea, Obstructive Sleep Apnea Syndromes Apnea Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Obesity Overnutrition Nutrition Disorders |