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NCT Number: NCT06716502

A New Portable Device for Non-invasive Ventilatory Support

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.

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Key information

Conditions

Healthy Respiration Disorders Respiratory Disease Respiratory Insufficiency Respiratory Tract Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Città di Lecce Hospital, Lecce, Apulia, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Arm 1

Inclusion criteria

  • 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

Inclusion criteria

  • Hospitalized adult patient
  • SpO2 of 90-93% in room air

Arm 2

Exclusion criteria

  • 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

Treatment and study plan

Portable CPAP efficacy

Device

The device will be tested in providing a PEEP comprised between 4-7,5 cmH2O

Portable CPAP usability assessment

Device

The device usability will be evaluated in individual's self-experience tests, i.e., in conditions where the volunteer will self-apply the device.

Primary outcomes

  1. 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.

  2. Duration of proper pressure delivery

    Time frame: Up to 2 hours

    Total time of target pressure (4 - 15 cmH2O) during 15-min test

  3. 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.

  4. Change in SpO2 level

    Time frame: Up to 2 hours

    Change in SpO2 before and during the device application

Study contacts

Contact information is provided by the study sponsor or research team.

Giovanni Landoni, MD

CONTACT

[email protected]

+39 022643 ext. 6151

Rosalba Lembo

CONTACT

[email protected]

+39 022643 ext. 6151

Sponsors and collaborators

Lead sponsor

Università Vita-Salute San Raffaele

Other

Collaborators

  • Azienda Ospedaliera Universitaria Integrata Verona
  • Città di Lecce Hospital

Registry information

Official study title

A New Portable Device for PRE-hospital Non-invasive VENTilatory Support in Acute Respiratory Failure

Acronym: PREVENT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 4, 2024
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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