Respiratory DiseaseNCT03613363
Engineering Evaluation of the Helix Ventilator
A study testing Helix Ventilator in people with Respiratory Disease and Pulmonary Disease, run by Philips Respironics at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Respiratory Disease, Pulmonary Disease, Pediatric ALL
- What is being tested?
- Helix Ventilator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2018to 7 Sep 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Following the completion of the informed consent, participants enrolled in this study will be asked to use their existing ventilator for up to 1 hour to collect pressure and flow data for comparison purposes against the Helix ventilator.
Participants will then be set up on the Helix Ventilatory System using the same mode of therapy as their current ventilator. Participants may receive mechanical ventilation using any patient circuit currently being designed for the Helix Ventilator (Passive, Active with Positive Airway Pressure (PAP), Active with Flow, or dual limb). Patients currently using non-invasive ventilation may be asked to use a mouth piece in lieu of a mask interface. While using the study device, therapy setting may be altered by the physician or his/her surrogate while maintaining the ventilator needs of the patient. For e.g.,a patient currently prescribed an synchronized intermittent mechanical ventilation (SIMV) mode may temporarily be switched to a pressure control mode to assess patient synchrony and ventilator performance.
Once the participant is set-up, he/she will be asked to use the ventilator for up to 4 hours. During this time, Philips Respironics engineers will be collecting data through several mechanisms: 1) Helix SanDisc (SD) Card, 2) Non-invasive Cardiac Output (NICO) Monitoring System, and / or 3) External data collection device (ex. laptop). The study staff may ask the participant's opinions on the comfort of the therapy delivery. There will be no invasive monitoring as part of this study.
The engineering evaluations will take place at the Boston Children's Health Physician offices. The study investigators, respiratory therapist, and/or other qualified clinical staff, will be supervising and present for all study visits. Philips Respironics engineers will be present for observational purposes only. All study staff working on this trial will be trained to the protocol and device prior to beginning work.
Participants may be asked to participate in this data collection study up to six (6) times.
Study data collected for this study will be collected on paper or electronic source records. These records will include information regarding inclusion/exclusion, performed study procedures and questions regarding device use. Only those staff that have been delegated by the Principal Investigator will be able to enter or make changes to the data in the Case Report Forms.
- Conditions
- Respiratory Disease, Pulmonary Disease, Pediatric ALL
- Being tested
- Helix Ventilator
- Medical subject headings
- Respiration Disorders, Lung Diseases, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Helix VentilatorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Helix Ventilator | Experimental | 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. Receives: Device: Helix Ventilator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proximal Pressure From Trilogy Evo Ventilator and Current Device
Proximal pressure from the participant's Trilogy Evo ventilator and current device
Measured: 1 day
Proximal Flow From Trilogy Evo and Patient's Current Device
Proximal flow from Trilogy Evo and patient's current device
Measured: 1 day
Secondary outcomes (1)
Subjective Ease-of-Operation Rating Regarding Trilogy Device
Subjective Ease-of-Operation rating (1-Very Easy to 5-Very Hard) regarding Trilogy device
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start6 Jun 2018
- Primary completion7 Sep 2021
- Study completion7 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Respiratory DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This trial is an engineering study is to verify the overall performance and controls of the Helix Ventilator as compared to the participant's current therapy device.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Respironics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03613363
- Sponsor's protocol ID
- HRC-17067-HCPED-CC
- Status last verified
- Jun 2025
- First submitted
- 9 Jul 2018
- Last updated
- 6 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: All data will stay within Philips.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engineering Evaluation of the Helix Ventilator
- ClinicalTrials.gov ID
- NCT03613363
- Acronym / sponsor ID
- HRC-17067-HCPED-CC
- Conditions
- Respiratory Disease, Pulmonary Disease, Pediatric ALL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Philips RespironicsIndustry (pharma, biotech, devices)
- Study start
- 6 Jun 2018 (actual)
- Primary completion
- 7 Sep 2021 (actual)
- Study completion
- 7 Sep 2021 (actual)
- First posted
- 3 Aug 2018 (actual)
- Results
- Posted 12 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Following the completion of the informed consent, participants enrolled in this study will be asked to use their existing ventilator for up to 1 hour to collect pressure and flow data for comparison purposes against the Helix ventilator.
Participants will then be set up on the Helix Ventilatory System using the same mode of therapy as their current ventilator. Participants may receive mechanical ventilation using any patient circuit currently being designed for the Helix Ventilator (Passive, Active with Positive Airway Pressure (PAP), Active with Flow, or dual limb). Patients currently using non-invasive ventilation may be asked to use a mouth piece in lieu of a mask interface. While using the study device, therapy setting may be altered by the physician or his/her surrogate while maintaining the ventilator needs of the patient. For e.g.,a patient currently prescribed an synchronized intermittent mechanical ventilation (SIMV) mode may temporarily be switched to a pressure control mode to assess patient synchrony and ventilator performance.
Once the participant is set-up, he/she will be asked to use the ventilator for up to 4 hours. During this time, Philips Respironics engineers will be collecting data through several mechanisms: 1) Helix SanDisc (SD) Card, 2) Non-invasive Cardiac Output (NICO) Monitoring System, and / or 3) External data collection device (ex. laptop). The study staff may ask the participant's opinions on the comfort of the therapy delivery. There will be no invasive monitoring as part of this study.
The engineering evaluations will take place at the Boston Children's Health Physician offices. The study investigators, respiratory therapist, and/or other qualified clinical staff, will be supervising and present for all study visits. Philips Respironics engineers will be present for observational purposes only. All study staff working on this trial will be trained to the protocol and device prior to beginning work.
Participants may be asked to participate in this data collection study up to six (6) times.
Study data collected for this study will be collected on paper or electronic source records. These records will include information regarding inclusion/exclusion, performed study procedures and questions regarding device use. Only those staff that have been delegated by the Principal Investigator will be able to enter or make changes to the data in the Case Report Forms.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This trial is an engineering study is to verify the overall performance and controls of the Helix Ventilator as compared to the participant's current therapy device.
| Arm | Type | Receives |
|---|---|---|
| Helix Ventilator | Experimental | Device: Helix VentilatorThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- Participants intubated with an endotracheal tube
- Clinically unstable, i.e.,
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Helix VentilatorThe 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. | Device | Helix Ventilator |
Primary outcome
Proximal Pressure From Trilogy Evo Ventilator and Current Device
Time frame: 1 day
Proximal pressure from the participant's Trilogy Evo ventilator and current device
Proximal Flow From Trilogy Evo and Patient's Current Device
Time frame: 1 day
Proximal flow from Trilogy Evo and patient's current device
1 secondary outcome
Subjective Ease-of-Operation Rating Regarding Trilogy Device
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. All data will stay within Philips.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Helix Ventilator in people with Respiratory Disease and Pulmonary Disease, run by Philips Respironics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proximal Pressure From Trilogy Evo Ventilator and Current Device (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025; AzTrials last refreshed its copy on 31 Oct 2026.