Engineering Evaluation of the Helix Ventilator

NCT03613363 | Completed Results FDA Device

• 1 other identifier: HRC-17067-HCPED-CC
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Respiratory Disease; Pulmonary Disease; Pediatric ALL

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Subjective Ease-of-Operation Rating Regarding Trilogy Device

  1 day

Study Arms (1)

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.

Device: Helix Ventilator

Interventions

Helix Ventilator DEVICE

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.

Helix Ventilator

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Weight \> 5Kg;
• Any medical condition requiring mechanical ventilation through nasal/facial mask, mouthpiece or tracheostomy
• Any medical condition requiring mechanical ventilation for \> 1 month

You may not qualify if:

• 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

Sponsors & Collaborators

• Philips Respironics: lead

Study Sites (1)

New York Medical College

Hawthorne, New York, 10532, United States

Location

MeSH Terms

Conditions

Respiration Disorders; Lung Diseases; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Results Point of Contact

• Title: Chuck Cain
• Organization: Philips

chuck.cain@philips.com

412-657-1814

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 9, 2018
• First Posted: August 3, 2018
• Study Start: June 6, 2018
• Primary Completion: September 7, 2021
• Study Completion: September 7, 2021
• Last Updated: June 6, 2025
• Results First Posted: June 12, 2023

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)