Engineering Evaluation of the Helix Ventilator

Study Overview
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Brief Summary
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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
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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.

Official Title
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Engineering Evaluation of the Helix Ventilator

Conditions
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Respiratory Disease, Pulmonary Disease, Pediatric ALL

Intervention / Treatment
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* Device: Helix Ventilator


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Helix Ventilator<br>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. | Device: Helix Ventilator<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proximal Pressure From Trilogy Evo Ventilator and Current Device | Proximal pressure from the participant's Trilogy Evo ventilator and current device | 1 day | 
| Proximal Flow From Trilogy Evo and Patient's Current Device | Proximal flow from Trilogy Evo and patient's current device | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Ease-of-Operation Rating Regarding Trilogy Device | Subjective Ease-of-Operation rating (1-Very Easy to 5-Very Hard) regarding Trilogy device | 1 day |