Clinical trial · Interventional
Engineering Evaluation of the Helix Ventilator
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pediatric ALL | Childhood Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Pulmonary Disease | — | UNRESOLVED | — |
| Respiratory Disease | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Helix Ventilator | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Helix Ventilator
- description
- The Helix ventilator is a non-FDA cleared ventilator device. The Helix ventilator has similar modalities to the Trilogy ventilator, which has FDA clearance. The Helix device has improved algorithms, controls, and features to enhance the therapy delivery. Additionally, Helix has an updated hardware platform which has been adequately tested to ensure that the device specifications are met. No pre-clinical or developmental clinical work was required because of Trilogy being the established predicate.
- interventionNames
- Device: Helix Ventilator
Primary outcomes (2)
- measure
- Proximal Pressure From Trilogy Evo Ventilator and Current Device
- timeFrame
- 1 day
- description
- Proximal pressure from the participant's Trilogy Evo ventilator and current device
- measure
- Proximal Flow From Trilogy Evo and Patient's Current Device
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available