Inspiratory-effort–targeted pressure support for adults on ventilators

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a two-arm, cluster randomized trial comparing a pressure support setting strategy guided by inspiratory effort (using the pressure muscle index, PMI) with the traditional tidal volume and respiratory rate (VT/RR)–guided strategy. Eighteen clusters are randomized 1:1 to either PMI-targeted or VT/RR-targeted pressure support, with usual ICU care protocols for triggers, cycle-off, FiO2, PEEP, spontaneous breathing trials, and weaning maintained. Adult patients intubated within seven days, started on pressure support within 24 hours, and with PaO2/FiO2 ≤ 300 are enrolled and followed for clinical outcomes related to ventilation and recovery. The trial tests whether matching ventilator assistance to measured inspiratory effort reduces over-assistance and improves meaningful patient outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Beijing Shijitan Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Jian-Xin Zhou, MD — Capital Medical University
• Study coordinator: Jian-Xin Zhou, MD
• Email: zhoujx.cn@icloud.com
• Phone: 8610 6392 6666

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.