Real-Time Algorithm-Driven Ventilation Feedback to Improve Lung-Protective Ventilation in Critically Ill Patients

Summary

The REALVENT trial is designed to evaluate whether a real-time, algorithm-driven ventilation feedback strategy can improve lung-protective ventilation (LPV) achievement rates in critically ill patients receiving invasive mechanical ventilation. This multicentre randomised controlled trial will compare real-time respiratory waveform monitoring with automated feedback against standard ICU care. The primary endpoint is the LPV achievement rate over the first 72 hours.

Conditions

• ARDS (Acute Respiratory Distress Syndrome)
• VILI (Ventilator-induced Lung Injury)
• Respiratory Failure
• Critical Illness

Interventions

DEVICE

REal-time Algorithm-driven Ventilation feedback to improve lung-protective ventilation in critically

Patients in the intervention arm will receive real-time ventilator waveform monitoring through the respiratory dynamics monitoring and feedback RemoteVentilate ViewTM system. The system continuously collects high-frequency waveform data (flow, pressure, volume) directly from the ventilator interface and analyses the following metrics: Tidal volume (VT) indexed to predicted body weight, Driving pressure (ΔP), Plateau pressure (Pplat), and Mechanical power (MP). Patient-ventilator asynchrony (PVA) events will be also collected in the system, including double triggering, ineffective efforts, reverse triggering, and flow starvation, ect..

OTHER

Standard ICU care

The control group will receive standard ICU care, including routine monitoring of ventilator parameters such as tidal volume, plateau pressure, and oxygenation status. No structured feedback or external ventilation reports will be provided. This reflects the prevailing standard of care in Chinese ICUs and is thus an appropriate comparator for assessing the added value of a real-time respiratory feedback platform.

Sponsors & Collaborators

• Beijing Hepingli Hospital

  collaborator UNKNOWN

• Beijing No.6 Hospital

  collaborator UNKNOWN

• Jinzhou Medical University

  collaborator OTHER

• Henan Provincial People's Hospital

  collaborator OTHER

• Binzhou Second People's Hospital

  collaborator UNKNOWN

• Chongqing General Hospital

  collaborator OTHER

• Qujing Central Hospital of Yunnan Province

  collaborator UNKNOWN

• Shandong Provincial Hospital

  collaborator OTHER_GOV

• Capital Medical University Affiliated Beijing Anzhen Hospital, Nanchong Center

  collaborator UNKNOWN

• Peking Union Medical College Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-12-30

Primary Completion

2026-06-30

Completion

2026-07-30