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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Guy's and St Thomas' NHS Foundation Trust.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01372072
First received: June 9, 2011
Last updated: June 10, 2011
Last verified: March 2011
  Purpose

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 Intervention
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)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study to Investigate the Physiological and Clinical Effects of Heated Humidification During Non-Invasive Ventilation

Resource links provided by NLM:


Further study details as provided by Guy's and St Thomas' NHS Foundation Trust:

Primary Outcome Measures:
  • Adherence to NIV [ Time Frame: up to 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 16
Study Start Date: June 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • psychiatric illness
  • pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01372072

Locations
United Kingdom
St Thomas' Hospital Not yet recruiting
London, United Kingdom
Contact: Swapna Mandal    02071888070    swapna.mandal@gstt.nhs.uk   
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
Investigators
Principal Investigator: Swapna Mandal Guy's and St Thomas' NHS Trust
  More Information

No publications provided

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
Study First Received: June 9, 2011
Last Updated: June 10, 2011
Health Authority: United Kingdom: National Research Ethics Service Committee-Westminster

Keywords provided by Guy's and St Thomas' NHS Foundation Trust:
chronic respiratory hypercapnic failure

Additional relevant MeSH terms:
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
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 Disorders
Obesity
Overnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on September 22, 2014