A New Portable Device for Non-invasive Ventilatory Support
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Portable CPAP efficacy, Portable CPAP usability assessment.
- Who it may be relevant to
- Registry conditions: Healthy, Respiratory Disease. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A New Portable Device for PRE-hospital Non-invasive VENTilatory Support in Acute Respiratory Failure
Overview
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.
Interventions
- Device Portable CPAP efficacy
The device will be tested in providing a PEEP comprised between 4-7,5 cmH2O - Device Portable CPAP usability assessment
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 outcome measures
- Device easiness-to-use [Time frame: Up to 2 hours]
- Duration of proper pressure delivery [Time frame: Up to 2 hours]
- Battery power consumption and duration [Time frame: Up to 2 hours]
- Change in SpO2 level [Time frame: Up to 2 hours]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Italy · 3 centers
- Città di Lecce Hospital — Lecce
- IRCCS San Raffaele — Milan
- Università degli studi di Verona — Verona
Identifiers
NCT: NCT06716502 · PNRR-POC-2022-12376704