Can a new breathing device help people in hospital with severe flare ups of chronic lung disease clear mucus and breathe more easily?

ISRCTN	ISRCTN58374348
DOI	https://doi.org/10.1186/ISRCTN58374348
Sponsor	Unidade Local de Saude do Alto Ave
Funder	Investigator initiated and funded

Submission date: 26/04/2026
Registration date: 05/05/2026
Last edited: 30/04/2026

Recruitment status: Recruiting
Overall study status: Ongoing
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Manuel Fernandes
Principal investigator, Public, Scientific

Hospital da Senhora da Oliveira, Guimarães. Serviço de Medicina Fisica e Reabilitação
Rua dos Cutileiros, Creixomil
Guimaraes
4835-044
Portugal

ORCID ID	0009-0005-4195-8279
Phone	+351 916405680
Email	manuel.fernandes@ulsaave.min-saude.pt

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Blinded (masking used)
Control	Placebo
Assignment	Parallel
Purpose	Device feasibility
Scientific title	Feasibility and benefits of an oscillatory negative-pressure device for secretion mobilization in patients hospitalized with acute COPD exacerbation - a randomized controlled trial
Study objectives	The aim of this study was to assess the feasibility and clinical effects of adding an oscillatory negative-pressure device to conventional respiratory physiotherapy in patients hospitalized for an acute exacerbation of COPD with secretion retention, compared with respiratory physiotherapy combined with a sham procedure.
Ethics approval(s)	Approved 14/05/2024, Comissão de ética da ULSAAVE (Hospital da Senhora da Oliveira, Guimarães. Comissão de Ética, Rua dos Cutileiros, Creixomil, Guimarães, 4835-044, Portugal; +351 253540330; comissaoetica@ulsaave.min-saude.pt), ref: 45/2024
Health condition(s) or problem(s) studied	Patients hospitalized with acute exacerbation of COPD
Intervention	Participants will be recruited by the attending physician in collaboration with a physiatrist, who confirmed the indication for respiratory rehabilitation. An initial interview will be conducted by one of the investigators to verify eligibility criteria and obtain written informed consent. After consent is obtained, the baseline assessment (Assessment 0) will be performed and recorded in the Case Report Form. In this first assessment, demographic data, clinical history and clinical evaluation (Vital signs, respiratory simptoms, CAT, Leicester acute) will be registered. Participants will then be randomized to either the intervention group or the control group using appropriate randomization software (Randomizer®) making a computer-generated allocation sequence. The control group will receive conventional respiratory physiotherapy (breathing retraining, controlled inspiratory slow breathing, Slow open glottis expirations, huffing and cough) combined with a sham procedure using the Semiox® device, while the intervention group will reveive similar respiratory physiotherapy combined with the Semiox® oscillatory negative-pressure device. Interventions will be carried out once a day by the principal investigator, an experienced physiotherapist, with the agreement of the attending physician.
Intervention type	Device
Phase	Phase II/III
Drug / device / biological / vaccine name(s)	Semiox® oscillatory negative-pressure device.
Primary outcome measure(s)	Sputum Weight (g) measured using a precision balance at 1 hour after treatment
Key secondary outcome measure(s)	COPD Impact (CAT) measured using CAT score at Every 3 days until study discharge Cough-Related Quality of Life (LCQ-acute) measured using Leicester cough questionnaire acute score at Every 3 days until study discharge Length of hospital stay (days) measured using Patient records at End of hospitalization
Completion date	31/12/2026

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Upper age limit	100 Years
Sex	All
Target sample size at registration	80
Key inclusion criteria	1. Patient with confirmed diagnosis of COPD 2. Hospitalized with respiratory onset 3. With an increase of his usual secretion production
Key exclusion criteria	1. Hemodynamic instability requiring vasopressor support 2. Severe respiratory failure defined as PaO₂/FiO₂ < 100 3. Respiratory failure requiring a fraction of inspired oxygen (FiO₂) > 60% 4. Altered level of consciousness or inability to cooperate with the intervention 5. Untreated or undrained pneumothorax 6. Massive hemoptysis 7. Unstable cardiovascular disease (e.g., acute coronary syndrome, uncontrolled arrhythmias) 8. Any clinical condition requiring strict bed rest or contraindicating participation in respiratory physiotherapy
Date of first enrolment	01/11/2024
Date of final enrolment	20/12/2026

Locations

Countries of recruitment

Portugal

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol file			30/04/2026	No	No

Additional files

49426 Protocol.pdf: Protocol file

Editorial Notes

27/04/2026: Trial's existence confirmed by Comissão de ética da ULSAAVE.