NCT06526598 Inspiratory Effort-Targeted Pressure Support Ventilation (IT-PSV) Trial
| NCT ID | NCT06526598 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Capital Medical University |
| Condition | Critical Care |
| Study Type | INTERVENTIONAL |
| Enrollment | 619 participants |
| Start Date | 2026-01-19 |
| Primary Completion | 2027-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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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 619 participants in total. It began in 2026-01-19 with a primary completion date of 2027-01-31.
⚠ 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
The Inspiratory effort-Targeted Pressure Support Ventilation (IT-PSV) is a cluster randomized controlled trial. Its main aim is to determine whether an inspiratory effort-targeted pressure support setting strategy, compared to the traditional tidal volume and respiratory rate target, can improve clinical outcomes in adult participants undergoing pressure support ventilation. The investigators propose a physiological-oriented assisted ventilation management that, if found effective, could potentially change the clinical practice for mechanical ventilation.
Eligibility Criteria
Mechanically ventilated patients, who are admitted to the ICU with acute hypoxic respiratory failure, will be consecutively screened daily at 08:00-10:00 morning rounds. Inclusion criteria: 1. PSV initiated during the last 24 hours; 2. Mechanical ventilation expected to be required for at least 24-48 h 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 included: 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. Extracorporeal support; 7. Moribund conditions; 8. Refusal by the ICU physicians or the patient.
Contact & Investigator
Jian-Xin Zhou, MD
PRINCIPAL INVESTIGATOR
Capital Medical University
Frequently Asked Questions
Who can join the NCT06526598 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 NCT06526598 currently recruiting?
Yes, NCT06526598 is actively recruiting participants. Contact the research team at zhoujx.cn@icloud.com for enrollment information.
Where is the NCT06526598 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06526598 clinical trial?
NCT06526598 is sponsored by Capital Medical University. The principal investigator is Jian-Xin Zhou, MD at Capital Medical University. The trial plans to enroll 619 participants.