N/A
Completed N=20
Engineering Evaluation of the Helix Ventilator
Respiratory Disease · Chronic Obstructive Pulmonary Disease · Pediatric ALL
Source: ClinicalTrials.gov NCT03613363 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcomePrimary: Proximal Pressure From Trilogy Evo Ventilator and Current Device — 8.3; 8.2 cm H2O
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proximal Pressure From Trilogy Evo Ventilator and Current Device |
8.3; 8.2 | — |
| PRIMARY Proximal Flow From Trilogy Evo and Patient's Current Device |
4.2; 4.9 | — |
| SECONDARY Subjective Ease-of-Operation Rating Regarding Trilogy Device |
1.9 | — |
Eligibility Criteria
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:
- Weight > 5Kg;
- Any medical condition requiring mechanical ventilation through nasal/facial mask, mouthpiece or tracheostomy
- Any medical condition requiring mechanical ventilation for > 1 month
Exclusion Criteria
- Participants intubated with an endotracheal tube
- Clinically unstable, i.e.,
- Acute Respiratory Failure
- Participants with refractory hypotension (defined as systolic blood pressure less than 90 mm Hg despite inotropic agents)
- Uncontrolled cardiac ischemia or arrhythmias d. Any participant determined as inappropriate for the study by the Principal Investigator
- Patients suffering from metastatic or terminal cancer
- Currently employed by a manufacturer of respiratory products or family member employed by a manufacturer of respiratory products
- Patient of surrogate is unable to provide informed consent
Data sourced from ClinicalTrials.gov (NCT03613363). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.