A Pilot Trial of Pressure Muscle Index-Targeted PSV Trial

Launched by CAPITAL MEDICAL UNIVERSITY · Jan 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two different methods for setting pressure support on ventilators for patients with severe breathing problems in the intensive care unit (ICU). The goal is to see if using a new measure called the Pressure Muscle Index (PMI) to adjust ventilator support leads to better outcomes compared to the traditional method, which adjusts support based on tidal volume (VT) and respiratory rate (RR). This trial will help researchers understand how well each method works and if they should conduct a larger study in the future.

To participate in this trial, patients must be adults who have recently started using a ventilator and are expected to need it for at least 24-48 hours. They should have specific breathing difficulties, but they cannot have certain medical conditions or be younger than 18 years old. During the trial, patients will receive ventilator support based on either the PMI or the traditional VT/RR method for a few weeks, and doctors will monitor their progress. The research team will also talk to healthcare providers to gather insights on what helps or hinders the trial process.

Gender

ALL

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.