Engineering Evaluation of the Helix Ventilator
This study will be used to evaluate and observe the overall performance and controls of the Helix ventilator. Pressure and flow data between participants' current devices and the Helix ventilator will be assessed in either invasive or non-invasive ventilation. To evaluate ventilator performance, pressure and waveform data will be assessed as well. Also, patient and caregiver feedback will be captured. The target population is infants to adults weighing more than 5kg. Participants will be recruited by Boston Children's Health Physician's Group. Up to thirty participants will be enrolled in the study.
Checked against the public recordLast updated Jun 6, 2025 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Other
- Study type
- Interventional
- Phase
- Not applicable
- Sponsor
- Philips Respironics
- Interventions being studied
- Device: Helix Ventilator
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: Participants who are currently using mechanical ventilation (\> 1 month at time of study participation) as part of medical care and have demonstrated a clinically acceptable response to this therapy and meet the following inclusion criteria: 1. Weight \> 5Kg; 2. Any medical condition requiring mechanical ventilation through nasal/facial mask, mouthpiece or tracheostomy 3. Any medical condition requiring mechanical ventilation for \> 1 month Exclusion Criteria: 1. Participants intubated with an endotracheal tube 2. Clinically unstable, i.e., 1. Acute Respiratory Failure 2. Participants with refractory hypotension (defined as systolic blood pressure less than 90 mm Hg despite inotropic agents) 3. Uncontrolled cardiac ischemia or arrhythmias d. Any participant determined as inappropriate for the study by the Principal Investigator 3. Patients suffering from metastatic or terminal cancer 4. Currently employed by a manufacturer of respiratory products or family member employed by a manufacturer of respiratory products 5. Patient of surrogate is unable to provide informed consent
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- New York Medical CollegeHawthorne, New York
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 6, 2025. Always confirm current availability with the study team.