NCT02651805.

Study name	Mechanical insufflator‐exsufflator to control mucus hypersecretion in patients in palliative care – a feasibility study
Methods	RCT
Participants	Hospitalised palliative care patients with mucous hypersecretion
Interventions	MI‐E vs usual care
Outcomes	Primary outcome Study feasibility assessed by verifying the recruitment rates, acceptability of the patients and hospital staff. Secondary outcomes Incidence of treatment‐emergent adverse events (safety and tolerability) (assessed between start of intervention and 30 min after end of intervention). Assessed by the number of times an event with change in physiological parameters occurred during the intervention (heart rate > 150 bpm or < 50 bpm; systolic blood pressure > 200 mmHg or < 80 mmHg; decrease of 5% or higher in pulse oximetry; haemoptysis). Effect size of palliative outcome scale (between immediately after the inclusion and in the final assessment (24 hours after inclusion). This is a quality‐of‐life multidimensional scale in patients in palliative care. Effect size of discomfort due to hypersecretion (immediately before the first intervention and 10 min after the first intervention). Assessed using a numeric scale (0–10). Effect size of discomfort due to the therapy (10 min after the first intervention). Assessed using a numeric scale (0–10) Effect size of time until the next intervention (at the end of the 24‐hour period). The moment immediately after the first intervention until the time a new intervention is required. Effect size of number of interventions during 24 hours (at end of 24‐hour period). The number of interventions will be verified in the patient's records.
Starting date	February 2016
Contact information	Juliano Ferreira Arcuri, Universidade Federal de Sao Carlos, Brazil
Notes	Attempts to contact the corresponding investigator were unsuccessful.