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Observational study on the lung protective effect of remifentanil based on driving pressure in ICU mechanically ventilated patients

Observational study on the lung protective effect of remifentanil based on driving pressure in ICU mechanically ventilated patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082542
Enrollment
Unknown
Registered
2024-04-01
Start date
2024-04-01
Completion date
Unknown
Last updated
2024-04-08

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

Conditions

ICU mechanical ventilation-induced lung injury

Interventions

Experimental group:Sedation with remifentanil, titrated within the range of 0 to 3 mg/kg/h.
Control group:Sedation with propofol, titrated within the range of 0 to 12 mg/kg/h.

Sponsors

Tianjin Nankai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 84 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18 to 84 years, of any gender; (2) Patients in the ICU undergoing invasive mechanical ventilation with a Lung Injury Prediction Score (LIPS) = 4; (3) Patients requiring light to moderate sedation (RASS score 0 to -3); (4) Voluntary participation with signed informed consent.

Exclusion criteria

Exclusion criteria: (1) Acute severe intracranial or spinal neurologic disease due to vascular causes, infection, or intracranial injury; (2) Severe bradycardia (HR<50 beats/min); (3) Atrioventricular block II-III (unless a pacemaker is installed); (4) Known allergy to any study drug or any excipient of the study drug; (5) Patients receiving sedative therapy for treatment indications (e.g., seizures) rather than for ventilator tolerance; (6) Patients unlikely to require ongoing sedation during mechanical ventilation (e.g., Guillain-Barré syndrome); (7) Patients unlikely to be weaned off the ventilator: e.g., irreversible diseases requiring long-term ventilatory support that primarily affects respiratory organ neuromuscular function, high-level spinal cord injuries, or advanced amyotrophic lateral sclerosis; (8) Distal tetraplegia; (9) Positive pregnancy test or currently breastfeeding; (10) Received any investigational drug within the past 30 days; (11) Concurrent participation in any other interventional study (patients allocated to different treatments in any study group and/or non-routine diagnostic or monitoring procedures).

Design outcomes

Primary

MeasureTime frame
Transpulmonary driving pressure;Electrical Impedance Tomography;

Secondary

MeasureTime frame
ANG-2;Endocan;KL-6;Fib;CRP; Lactic acid;IL-6;IL-8; BIS;Mechanical ventilation time;Murray lung injury score;Administration of neuromuscular blocking agents;ICU monitoring duration;Blood gas analysis indicators;Total length of hospital stay;Total dose of sedative drugs;Total amount of analgesic drug use;30-day mortality rate;Hemodynamics;

Countries

China

Contacts

Public ContactYu Jianbo

Tianjin Nankai Hospital

30717008@nankai.edu.cn+86 186 9808 7176

Outcome results

None listed

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