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

NCT ID: NCT01372072

Last Updated: 2021-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-01
• Study Completion Date: 2014-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Humidification

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DEVICE

Heated humidification (Fisher-Paykel MR810 and MR850 humidifiers)

NIV without humidifivation

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Heated humidification (Fisher-Paykel MR810 and MR850 humidifiers)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• psychiatric illness
• pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guy's and St Thomas' NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Swapna Mandal

Role: PRINCIPAL_INVESTIGATOR

Guy's and St Thomas' NHS Foundation Trust

Locations

St Thomas' Hospital

London, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 32366486 (View on PubMed)

Other Identifiers

RJ1 11/N141

Identifier Type: -

Identifier Source: org_study_id