NCT06769360 A Pilot Trial of Pressure Muscle Index-Targeted PSV Trial
| NCT ID | NCT06769360 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Capital Medical University |
| Condition | Critical Care |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-01-20 |
| Primary Completion | 2025-03-15 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-01-20 with a primary completion date of 2025-03-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Pressure support ventilation (PSV) is one of the most frequently used ventilator modes in the intensive care unit (ICU). The successful implementation of PSV depends on matching the patient's inspiratory effort with the ventilator support. In clinical practice, the pressure support level is usually set and adjusted according to tidal volume (VT) and respiratory rate (RR). However, these parameters may not fully represent the patient's effort. Previous studies have shown that pressure muscle index (PMI), which is measured as the difference between the peak and plateau airway pressure during an end-inspiratory airway occlusion, could reliably determine the low and high inspiratory effort during PSV. However, the comparative effectiveness of these two pressure support level setting strategies remains uncertain. Our aim is to explore clinical and implementation factors relevant to a future definitive randomized controlled trial to evaluate PMI - and VT/RR - pressure support level setting strategies. The Inspiratory effort-targeted pressure support ventilation pragmatic pilot trial will test clinician adherence and to explore clinical outcomes. Two centers are included in a pragmatic sequential cluster crossover pilot trial. We enrolled all eligible adults with acute respiratory failure requiring mechanical ventilation admitted to ICU. The pressure support level setting strategy was assigned according to the epoch. The first trial epoch will be assigned to VTRR - pressure support level setting strategy for 4 weeks. The washout week between the two epochs will be 4 weeks. Then sequentially, it will be crossed over to PMI - pressure support level setting strategy for 4 weeks. * In the VT/RR-targeted group, the pressure support is adjusted to obtain a VT between 6 and 8 ml/kg PBW and RR between 20 and 35 breaths/min until day 28 or death or performance of spontaneous breathing trial (SBT). * In the PMI-targeted group, the pressure support is adjusted according to PMI between 0 and 2 cmH2O until day 28 or death or performance of SBT. We will also survey clinicians to understand potential facilitators and barriers to conducting a definitive randomized trial.
Eligibility Criteria
Inclusion Criteria: 1. PSV initiated during the last 24 hours, whether transition from controlled modes or primary initiation; 2. Mechanical ventilation expected to be required for at least 24-48 hours by responsible physicians; 3. The partial pressure of oxygen in arterial blood (PaO2)/inspired oxygen fraction (FiO2) ≤ 300 mmHg (measuring at clinical FiO2 and positive end-expiratory pressure \[PEEP\]); 4. No sedation or stable sedation with Richmond Agitation Sedation Scale (RASS) of -2 to +1 or Riker's Sedation-Agitation Scale (SAS) of 3 to 4. Exclusion Criteria: 1. Age younger than 18 years old; 2. Initiation of PSV before ICU admission; 3. Duration of mechanical ventilation longer than 7 days before enrollment; 4. History of neuromuscular diseases; 5. Clinical suspicion of increased intracranial pressure; 6. Presentation with pneumothorax and/or bronchopleural fistula; 7. Extracorporeal support; 8. Moribund conditions; 9. Refusal by the ICU physicians or the patient.
Contact & Investigator
Jian-Xin Zhou, MD
PRINCIPAL INVESTIGATOR
Beijing Shijitan Hospital, Capital Medical University
Frequently Asked Questions
Who can join the NCT06769360 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Critical Care. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06769360 currently recruiting?
Yes, NCT06769360 is actively recruiting participants. Contact the research team at zhoujx.cn@icloud.com for enrollment information.
Where is the NCT06769360 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06769360 clinical trial?
NCT06769360 is sponsored by Capital Medical University. The principal investigator is Jian-Xin Zhou, MD at Beijing Shijitan Hospital, Capital Medical University. The trial plans to enroll 60 participants.