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

NCT01372072 | Completed

• 1 other identifier: RJ1 11/N141
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease; Chronic Respiratory Hypercapnic Failure; Neuromuscular Disease; Obesity Hypoventilation Syndrome

Keywords

chronic respiratory hypercapnic failure

Outcome Measures

Primary Outcomes (1)

• Adherence to NIV

  up to 8 weeks

Study Arms (2)

Humidification

ACTIVE COMPARATOR

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)

NIV without humidifivation

NO INTERVENTION

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

Interventions

non-invasive ventilation heated humidification (Fisher-Paykel MR810 and MR850 humidifiers) DEVICE

Heated humidification (Fisher-Paykel MR810 and MR850 humidifiers)

Humidification

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• psychiatric illness
• pregnancy

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

Study Sites (1)

St Thomas' Hospital

London, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 32366486 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Neuromuscular Diseases; Obesity Hypoventilation Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nervous System Diseases; Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Hypoventilation; Respiratory Insufficiency; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Swapna Mandal

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2011
• First Posted: June 13, 2011
• Study Start: February 1, 2012
• Primary Completion: September 30, 2014
• Study Completion: September 30, 2014
• Last Updated: October 8, 2021

Record last verified: 2021-09

Locations

GB (1)