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Study on the impact of mechanical ventilation monitoring report on the prognosis of critically ill patients with mechanical ventilation: a prospective multicenter randomized controlled trial

Study on the impact of mechanical ventilation monitoring report on the prognosis of critically ill patients with mechanical ventilation: a prospective multicenter randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105056
Enrollment
Unknown
Registered
2025-06-27
Start date
2025-12-29
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

1. Acute Respiratory Distress Syndrome(ARDS)

Interventions

Respiratory-Dynamics Monitoring Feedback (RDMF) Group:REal-time Algorithm-driven Ventilation feedback to improve lung-protective ventilation in critically
Conventional Monitoring (CM) Group:Clinicians only adjust the ventilator parameters according to the traditional way of adjusting breathing.

Sponsors

Peking Union Medical College Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1.Age between 18 and 75 years; 2.Receiving invasive mechanical ventilation via endotracheal intubation at the time of screening; 3.Initiated mechanical ventilation within the past 24 hours; 4.PaO2/FiO2 =8 cmH2O (or, if arterial blood gas unavailable, SpO2/FiO2 =72 hours after enrolment.

Exclusion criteria

Exclusion criteria: 1.Receiving extracorporeal membrane oxygenation (ECMO) or high-frequency oscillatory ventilation; 2.Chronic ventilator dependence (>= 21 consecutive days of ventilation prior to admission); 3.Brain death or life-sustaining treatment withdrawal anticipated within 72 hours; 4.Pregnancy; 5.Known neuromuscular disease affecting spontaneous respiratory effort; 6.Prisoners or individuals unable to provide surrogate consent; 7.Simultaneous enrolment in another interventional ICU study; 8.Lack of digital infrastructure for real-time ventilator waveform acquisition.

Design outcomes

Primary

MeasureTime frame
Lung Protection Ventilation Bundles Achievement;

Secondary

MeasureTime frame
Ventilator-free days at day 28 (VFD-28);ICU length of stay;ECMO initiation rate;Clinician satisfaction and perceived workload;Incidence of barotrauma;Incidence of ventilator-associated pneumonia (VAP);Intervention Adherence Indicator;Inflammatory biomarkers;Mortality at day 28;

Countries

China

Contacts

Public ContactLongxiang Su

Peking Union Medical College Hospital

slx77@163.com+86 10 6915 2308

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026