How PICS affects breathing during weaning from prolonged mechanical ventilation
Impact of Persistent Inflammation-Immunosuppression-Catabolism Syndrome (PICS) on the Respiratory Physiology in Patients With Prolonged Mechanical Ventilation
National Taiwan University Hospital · NCT07002710
This project will test whether people with PICS have more lung collapse, lower oxygen levels, and higher breathing effort when trying to wean from long-term ventilator support.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | National Taiwan University Hospital (other) |
| Locations | 1 site (Taipei) |
| Trial ID | NCT07002710 on ClinicalTrials.gov |
What this trial studies
Investigators will enroll 60 patients who have been on mechanical ventilation for at least 10 days and are transferred to a respiratory care center for weaning. Patients will be classified as PICS or non-PICS using laboratory analyses and biomarkers. During weaning trials the team will collect respiratory-physiology measures (oxygenation changes, work of breathing, diaphragm ultrasound, esophageal pressure, electrical impedance tomography), infection data, and inflammatory biomarkers. The one-year project aims to compare the prevalence of PICS in stable prolonged-ventilation patients and to identify differences in respiratory physiology and weaning outcomes between groups.
Who should consider this trial
Good fit: Adults who have used a respirator continuously for at least 10 days, are transferred to the Respiratory Care Center with stable vital signs and FiO2 ≤ 60%, and are willing and able to attempt weaning are ideal candidates.
Not a fit: Patients who are pregnant, who refuse weaning, who lack spontaneous breathing ability, or who are hemodynamically or respiratory unstable (e.g., needing >60% oxygen) are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the findings could help personalize weaning strategies and reduce lung injury, weaning failure, and complications among prolonged mechanically ventilated patients with PICS.
How similar studies have performed: Prior studies have described PICS prognosis in ICU populations, but applying detailed respiratory-physiology measurements during weaning in respiratory care centers is largely novel and not yet proven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients are still receiving ventilator support when transferred to the ward where the study is conducted. * Use the respirator continuously for at least 10 days. * Vital signs are stable: blood pressure systolic blood pressure is not lower than 70 mmHg; heartbeat is not lower than 50/min and not higher than 160/min; respiratory rate is not higher than 50/min. * When using respirator support, the oxygen concentration should not exceed 60%. Exclusion Criteria: .At least one of the following conditions occurs: 1. Pregnancy. 2. The patient refuses to undergo weaning from the respirator training. 3. The patient has no ability to drive spontaneous breathing.
Where this trial is running
Taipei
- National Taiwan University Hospital — Taipei, Taiwan (RECRUITING)
Study contacts
- Study coordinator: Jih-Shuin Jerng, MD, PhD, Principal Investigator
- Email: jsjerng@ntu.edu.tw
- Phone: +886-2-23123456
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: PICS