Evaluation of an on-demand humidifier in neuromuscular patients on chronic ventilatory support; a pilot study.

Evaluation of an on-demand humidifier in neuromuscular patients on chronic ventilatory support; a pilot study. - On-demand humidifier in chronic ventilatory support

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46789

Enrollment

Registered

2018-05-16

Start date

2018-01-12

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuromuscular disease

Interventions

The study starts with the recruitment, including explanation of the trial and signing the informed consent form, and testing the on-demand humidification devices in 10 neuromuscular patients requiri

chronic ventilatory support

Home mechanical venitlation

neuromuscular disease

on-demand humidification

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: 1. Age > 18 of age;

Exclusion criteria

Exclusion criteria: 1. Clinically unstable, i.e., a. Acute respiratory failure b. Participants with hypotension (defined as systolic blood pressure less than 90 mm Hg despite inotropic agents) c. Uncontrolled cardiac ischemia or arrhythmias d. Any participant determined as inappropriate for the study by the Principal Investigator 2. Patients suffering from metastatic or terminal cancer 3. Patients lacking the functional capacity for medical decision-making.

Design outcomes

Primary

Measure	Time frame
To determine and evaluate the optimal amount of humidification doses delivered by the On-Demand humidification system in neuromuscular patients requiring home mechanical ventilation. The patients perception will be monitored with subjective as well as with objective measurements of the optimum comfortable on-demand humidification doses. The primary hypothesis is that the perception and preference of the optimal amount of humidification provided by the on-demand humidification for subjects requiring mechanical ventilation will be better when compared to humidification supplied by their presently used humidifier or no humidification. This hypothesis will be tested in the study by evaluating the optimum comfortable amount of on-demand humidification for the patient in a step by step increasing humidification test and evaluating patients perception with subjective measures (questionnaire based on Borg Scale, Visual Analog scale) as well as objective measures (e.g. heart rate,breathing rate, SpO2, transcutaneous CO2, number of mucus clearance events (recorded in test log).	—

Measure

Time frame

To determine and evaluate the optimal amount of humidification doses delivered by the On-Demand humidification system in neuromuscular patients requiring home mechanical ventilation. The patient*s perception will be monitored with subjective as well as with objective measurements of the optimum comfortable on-demand humidification doses. The primary hypothesis is that the perception and preference of the optimal amount of humidification provided by the on-demand humidification for subjects requiring mechanical ventilation will be better when compared to humidification supplied by their presently used humidifier or no humidification. This hypothesis will be tested in the study by evaluating the optimum comfortable amount of on-demand humidification for the patient in a step by step increasing humidification test and evaluating patient*s perception with subjective measures (questionnaire based on Borg Scale, Visual Analog scale) as well as objective measures (e.g. heart rate,breathing rate, SpO2, transcutaneous CO2, number of mucus clearance events (recorded in test log).

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Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)