HealthyPREVENTNCT06716502
A New Portable Device for Non-invasive Ventilatory Support
A study testing Portable CPAP efficacy and Portable CPAP usability assessment in people with Healthy and Respiratory Disease, run by Università Vita-Salute San Raffaele at 3 sites in Italy.
Trial summary
Acute respiratory failure is a medical emergency rapidly leading to death, if not timely treated. Prompt Continuous Positive Airway Pressure (CPAP) improves patient outcomes. However, pre-hospital CPAP is currently limited to healthcare providers due to the absence of easy-to-use and immediate devices specifically… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy, Respiratory Disease
- What is being tested?
- Portable CPAP efficacy and Portable CPAP usability assessment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesItaly
- Study dates
- 17 Sep 2025to 19 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age ≥65 years
- Clinically stable: non-hospitalized and not in acute illness
- no professional medical knowledge: no experience as a health care provider
- Ability to express informed consent as requested by the ethical committee
- Arm 1 Exclusion Criteria: none
- Arm 2
Show all 9Show fewer
- Hospitalized adult patient
- SpO2 of 90-93% in room air
- Arm 2
Who cannot join
- Facial burns/trauma/recent facial or upper airway surgery
- Vomiting
- Fixed upper airway obstruction
- Undrained pneumothorax
- Recent upper gastrointestinal surgery
- Inability to protect the airway
- Bowel obstruction
- Patient refusal
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy3 sites, 3 recruiting
- Not yet recruiting
Città di Lecce Hospital
Lecce, Apulia
Giuseppe Santarpino, MD
- Recruiting
IRCCS San Raffaele
Milan, 20132
Giovanni Landoni, MD, landoni.giovanni@hsr.it
- Not yet recruiting
Università degli studi di Verona
Verona
Katia Donadello, MD
About this study
Official title: A New Portable Device for PRE-hospital Non-invasive VENTilatory Support in Acute Respiratory Failure
Acute respiratory failure is a medical emergency rapidly leading to death, if not timely treated. Prompt Continuous Positive Airway Pressure (CPAP) improves patient outcomes. However, pre-hospital CPAP is currently limited to healthcare providers due to the absence of easy-to-use and immediate devices specifically designed for the non-medical population.
The efficacy and usability of a new portable CPAP device will be assessed. This device is specifically designed for potential use in out-of-hospital scenarios involving acute respiratory failure. The evaluation will focus not only on the performance of the device but also on its easiness of use.
Read the detailed description
The efficacy and usability of a new portable CPAP device will be assessed in different clinical settings. The study will take place in three hospitals in Italy, with the objective of collecting data to support the future implementation of the device as a first-aid support tool for patients with respiratory failure in real-world scenarios.
- Conditions
- Healthy, Respiratory Disease
- Being tested
- Portable CPAP efficacy, Portable CPAP usability assessment
- Keywords
- CPAP, NIV, Respiratory failure
- Medical subject headings
- Respiration Disorders, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Portable CPAP efficacyDevice
The device will be tested in providing a PEEP comprised between 4-7,5 cmH2O
Portable CPAP usability assessmentDevice
The device usability will be evaluated in individual's self-experience tests, i.e., in conditions where the volunteer will self-apply the device.
| Study group | Role | What they receive |
|---|---|---|
| Healthy elderly individuals | Experimental | The performance and easiness to use of the device will be evaluated in patients' self-experience conditions, with elderly participants self-applying the device. Receives: Device: Portable CPAP usability assessment |
| Patients with mild oxygenation impairment | Experimental | The efficacy of the device will be assessed in patients with mild oxygenation impairment. Receives: Device: Portable CPAP efficacy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device easiness-to-use
Volunteers in self-experience tests will be asked to assign a score depending on the easiness-to-use of the device and comfort during the device operation.
A semantic differential scale will be used between "hard to use" (corresponding to the score 1) and "easy to use" (corresponding to the score 5). The best result is represented by a higher score, with 5 being the highest and 1 the lowest.
Measured: Up to 2 hours
Duration of proper pressure delivery
Total time of target pressure (4 - 15 cmH2O) during 15-min test
Measured: Up to 2 hours
Battery power consumption and duration
We will set 15 minutes of continuous device operation as an efficacy threshold and will assess the battery status at the end of each experiment.
Measured: Up to 2 hours
Change in SpO2 level
Change in SpO2 before and during the device application
Measured: Up to 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start17 Sep 2025
- Primary completion19 May 2026 (estimated)
- Study completion19 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università Vita-Salute San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliera Universitaria Integrata Verona, Città di Lecce Hospital
- Responsible party
- Principal investigator, Giovanni Landoni, IRCCS San Raffaele
- Investigators
- Giovanni Landoni, MD, Study chair, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06716502
- Sponsor's protocol ID
- PNRR-POC-2022-12376704
- Acronym
- PREVENT
- Status last verified
- May 2026
- First submitted
- 14 Nov 2024
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Portable Device for PRE-hospital Non-invasive VENTilatory Support in Acute Respiratory Failure
- ClinicalTrials.gov ID
- NCT06716502
- Acronym / sponsor ID
- PREVENT / PNRR-POC-2022-12376704
- Conditions
- Healthy, Respiratory Disease
- Keywords
- CPAP, NIV, Respiratory failure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Università Vita-Salute San RaffaeleUniversity, hospital or other
- Collaborators
- Azienda Ospedaliera Universitaria Integrata Verona, Città di Lecce Hospital
- Study start
- 17 Sep 2025 (actual)
- Primary completion
- 19 May 2026 (estimated)
- Study completion
- 19 Jun 2026 (estimated)
- First posted
- 4 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acute respiratory failure is a medical emergency rapidly leading to death, if not timely treated. Prompt Continuous Positive Airway Pressure (CPAP) improves patient outcomes. However, pre-hospital CPAP is currently limited to healthcare providers due to the absence of easy-to-use and immediate devices specifically designed for the non-medical population.
The efficacy and usability of a new portable CPAP device will be assessed. This device is specifically designed for potential use in out-of-hospital scenarios involving acute respiratory failure. The evaluation will focus not only on the performance of the device but also on its easiness of use.
Detailed description
The efficacy and usability of a new portable CPAP device will be assessed in different clinical settings. The study will take place in three hospitals in Italy, with the objective of collecting data to support the future implementation of the device as a first-aid support tool for patients with respiratory failure in real-world scenarios.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy elderly individuals | Experimental | Device: Portable CPAP usability assessmentThe performance and easiness to use of the device will be evaluated in patients' self-experience conditions, with elderly participants self-applying the device. |
| Patients with mild oxygenation impairment | Experimental | Device: Portable CPAP efficacyThe efficacy of the device will be assessed in patients with mild oxygenation impairment. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- Age ≥65 years
- Clinically stable: non-hospitalized and not in acute illness
- no professional medical knowledge: no experience as a health care provider
- Ability to express informed consent as requested by the ethical committee
- Arm 1 Exclusion Criteria: none
Key exclusion criteria (8 listed)
- Facial burns/trauma/recent facial or upper airway surgery
- Vomiting
- Fixed upper airway obstruction
- Undrained pneumothorax
- Recent upper gastrointestinal surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Portable CPAP efficacyThe device will be tested in providing a PEEP comprised between 4-7,5 cmH2O | Device | Patients with mild oxygenation impairment |
| Portable CPAP usability assessmentThe device usability will be evaluated in individual's self-experience tests, i.e., in conditions where the volunteer will self-apply the device. | Device | Healthy elderly individuals |
Primary outcome
Device easiness-to-use
Time frame: Up to 2 hours
Volunteers in self-experience tests will be asked to assign a score depending on the easiness-to-use of the device and comfort during the device operation. A semantic differential scale will be used between "hard to use" (corresponding to the score 1) and "easy to use" (corresponding to the score 5). The best result is represented by a higher score, with 5 being the highest and 1 the lowest.
Duration of proper pressure delivery
Time frame: Up to 2 hours
Total time of target pressure (4 - 15 cmH2O) during 15-min test
Battery power consumption and duration
Time frame: Up to 2 hours
We will set 15 minutes of continuous device operation as an efficacy threshold and will assess the battery status at the end of each experiment.
Change in SpO2 level
Time frame: Up to 2 hours
Change in SpO2 before and during the device application
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Giovanni Landoni, MD study chair
IRCCS San Raffaele
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Portable CPAP efficacy and Portable CPAP usability assessment in people with Healthy and Respiratory Disease, run by Università Vita-Salute San Raffaele at 3 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giovanni Landoni, MD (+39 022643 ext. 6151, landoni.giovanni@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device easiness-to-use (time frame: Up to 2 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.