Engineering Evaluation of the Helix Ventilator

Study 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.

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Key things to know

Main goalOther

This describes the study’s primary purpose.

What is being studiedHelix Ventilator

The study team can explain what participation involves.

Who it may be forRespiratory Disease · Pulmonary Disease

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jun 6, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Philips Respironics

Study sponsor

Study overview

What this study is about

Purpose: Other
Study type: Interventional
Phase: Not applicable
Sponsor: Philips Respironics
Interventions being studied: Device: Helix Ventilator

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion 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.

Study sites

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.

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