Continuous Flow Ventilation With the Ventijet System in Acute Respiratory Distress Syndrome: a First-in-Human Feasibility and Non-Inferiority Trial

NCT07121257 | Completed DMC

• 2 other identifiers: Ventijet012020/9238
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, non-randomized, single-arm, proof-of-concept clinical trial evaluates the physiological performance and safety of the Ventijet System, a hybrid ventilation system based on continuous high-velocity gas flow. The system was conceived during the coronavirus disease 2019 (COVID-19) pandemic as a response to ventilator shortages, building upon a previously patented continuous-flow nozzle system developed by Dr. Lucas Picazo in the 1990s. The concept combines the physiological benefits of continuous flow ventilation (CFV) with the potential ease of design, monitoring, and scalability. Patients with moderate acute respiratory distress syndrome (ARDS) - defined by a ratio of arterial partial pressure of oxygen to inspired oxygen fraction (PaO₂/FiO₂) between 150 and 200 mmHg - were first stabilized on a conventional mechanical ventilator (Puritan Bennett 840, PB840) using lung-protective settings. They were then transitioned to the Ventijet system following a structured protocol that included real-time monitoring and esophageal pressure measurements. The primary endpoint was oxygenation, measured as the change in PaO₂ after one hour of ventilation with the Ventijet system compared to baseline values under conventional ventilation. The study was designed to demonstrate non-inferiority, with a predefined margin of ±20 mmHg in PaO₂. Secondary outcomes included carbon dioxide clearance (PaCO₂), respiratory system mechanics, safety events, and feasibility in intensive care unit (ICU) conditions.

Conditions

ARDS; Mechanical Ventilation; Hypoxemic Respiratory Failure

Keywords

Continuous Flow Ventilation; Mechanical Ventilation; Jet Ventilation; VENTIJET; ARDS; Respiratory Mechanics

Outcome Measures

Primary Outcomes (1)

• Oxygenation efficiency (PaO₂ variation at 1 hour)

  Change in arterial partial pressure of oxygen (PaO₂) measured by arterial blood gas analysis after 1 hour of ventilation with the Ventijet system, compared to PaO₂ under conventional mechanical ventilation (PB840) after 1 hour of stabilization (conventional-1h phase).

  1 hour after connection to Ventijet system.

Secondary Outcomes (1)

• Change in arterial partial pressure of carbon dioxide (PaCO₂) after 1 hour of ventilation with VENTIJET compared to conventional ventilation.

  1 hour after connection to the Ventijet system.

Other Outcomes (8)

• PaO₂/FiO₂ ratio (oxygenation index)

  At baseline (under conventional mechanical ventilation with PB840); after 1, 6, 12, and 24 hours of Ventijet ventilation; and at 1, 12, and 24 hours after reconnection to conventional ventilator.

• PaCO₂

  At baseline (under conventional mechanical ventilation with PB840); after 1, 6, 12, and 24 hours of Ventijet ventilation; and at 1, 12, and 24 hours after reconnection to conventional ventilator.

• Compliance of the respiratory system (Crs)

  At baseline (under conventional mechanical ventilation with PB840); after 1, 6, 12, and 24 hours of Ventijet ventilation; and at 1, 12, and 24 hours after reconnection to conventional ventilator.

Study Arms (1)

Continuous Flow Ventilation with VENTIJET

EXPERIMENTAL

All patients were initially ventilated with a conventional mechanical ventilator (PB840) under lung-protective settings. After a 1-hour stabilization and baseline assessment period, patients were transitioned to continuous flow ventilation using the Ventijet system for up to 24 hours, followed by reconnection to the conventional ventilator for post-intervention follow-up.

Device: VENTIJET system

Interventions

VENTIJET system DEVICE

The Ventijet system is an investigational ventilation device delivering continuous high-velocity gas flow through a proximal nozzle. The system is designed to maintain alveolar recruitment with low driving pressures, acting as an expiratory brake. Patients received continuous flow ventilation using Ventijet for 1 to 24 hours after baseline assessment with conventional mechanical ventilation.

Also known as: Continuous Flow Ventilation

Continuous Flow Ventilation with VENTIJET

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years.
• Invasive mechanical ventilation via endotracheal tube.
• Diagnosis of moderate ARDS according to the Berlin Definition (PaO₂/FiO₂ between 150 and 200 mmHg with PEEP ≥ 5 cmH₂O).
• Informed consent obtained from the patient's legal representative.

You may not qualify if:

• Known obstructive pulmonary disease (e.g., COPD, asthma).
• Severe hemodynamic instability or uncontrolled shock.
• Pregnancy.
• Do-not-resuscitate (DNR) orders or limitations of life support.
• Anticipated need for ECMO in the next 24 hours.
• Presence of pneumothorax or bronchopleural fistula.
• Contraindications to esophageal pressure monitoring.

Sponsors & Collaborators

• Hospital del Mar: lead
• Hospital del Mar Research Institute (IMIM): collaborator

Study Sites (1)

Hospital del Mar

Barcelona, Barcelona, 08003, Spain

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Lucía Picazo, MD

  Intensive Care Department, Hospital del Mar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking was applied. All investigators and clinicians were aware of the ventilation mode at each study phase.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator and Intensive Care Specialist at Hospital del Mar

Model Details: Prospective, unicentric, non-randomized, single-group assignment study. All enrolled patients were initially managed with conventional mechanical ventilation (PB840) and subsequently transitioned to the Ventijet system in a sequential protocol that included predefined assessment phases (1 hour, 6 hours, 12 hours, 24 hours), followed by re-connection to conventional ventilation for additional monitoring. Each patient served as their own control.

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 13, 2025
• Study Start: June 8, 2021
• Primary Completion: December 16, 2022
• Study Completion: March 16, 2023
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)