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Search / Trial NCT06526598

Inspiratory Effort-Targeted Pressure Support Ventilation (IT-PSV) Trial

Launched by CAPITAL MEDICAL UNIVERSITY · Jul 29, 2024

Trial Information

Current as of August 21, 2025

Not yet recruiting

Keywords

Pressure Support Ventilation Pressure Muscle Index Inspiratory Effort

ClinConnect Summary

The Inspiratory Effort-Targeted Pressure Support Ventilation (IT-PSV) Trial is a study designed to find out if a new way of helping patients breathe on a ventilator can lead to better health outcomes. This method focuses on adjusting the support provided by the ventilator based on how much effort the patient is making to breathe, rather than just the amount of air they need. The goal is to see if this approach is more effective than the standard method, which relies on set targets for air volume and breathing rate.

To participate in this trial, patients need to be adults who are currently on a ventilator in the intensive care unit (ICU) due to a serious condition that makes it hard for them to get enough oxygen. They must have started using the ventilator within the last 24 hours and meet specific health criteria, such as having stable sedation. People under 18 years old or those with certain medical conditions will not be eligible. If chosen to participate, patients will receive the new ventilatory support method to see if it helps them recover more effectively.

Gender

ALL

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. 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);
  • 3. 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.

About Capital Medical University

Capital Medical University is a leading institution in medical education and research, dedicated to advancing healthcare through innovative clinical trials. With a strong emphasis on scientific rigor and ethical standards, the university collaborates with a network of healthcare professionals and researchers to drive breakthroughs in medical science. Capital Medical University aims to enhance patient care and improve health outcomes by fostering a multidisciplinary approach to clinical research, ensuring that its trials are designed to address critical health challenges and contribute valuable insights to the medical community.

Locations

Beijing, Beijing, China

Patients applied

0 patients applied

Trial Officials

Jian-Xin Zhou, MD

Principal Investigator

Capital Medical University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported