Autonomic Modulation in Patients Undergoing Assisted Mechanical Ventilation: Comparison Between PAV+ and PSV
Launched by UNIVERSITY OF ROMA LA SAPIENZA · Sep 6, 2024
Trial Information
Current as of July 01, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at how two different modes of mechanical ventilation—PAV+ and PSV—affect patients' heart rate and overall nervous system balance while they are being supported on a ventilator. The researchers believe that the PAV+ mode, which helps patients breathe in a way that is more natural and synchronized with their efforts, might help improve heart function more effectively than the PSV mode. This study aims to help doctors understand which method may be better for patients who are not yet ready to breathe on their own.
To participate in this trial, patients must be at least 18 years old, currently in the ICU, and have been on mechanical ventilation for at least three days. They should be eligible for support but not yet ready to breathe completely independently. However, there are some patients who cannot participate, such as those with serious heart issues, certain kinds of injuries, or conditions that affect their ability to give consent. If eligible, participants can expect to be monitored closely as researchers gather data on their heart health and breathing patterns while using the different ventilation modes.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Patients admitted to the ICU, ≥18 years old, undergoing invasive controlled mechanical ventilation for at least 72 hours, eligible for assisted support but not yet ready for extubation or spontaneous breathing.
- Exclusion Criteria:
- • Successful completion of a spontaneous breathing trial (SBT) and spontaneous breathing within 24 hours of enrollment
- • Acute ischemic heart disease, cardiac rhythm abnormalities, and/or patients with pacemakers and/or treated with anti-arrhythmic drugs
- • Hemodynamic instability
- • Chest drainage
- • Severe anemia (Hb \<7g/dL)
- • Pregnancy
- • Severe head trauma, dementia
- • High spinal cord injury
- • Neuromuscular disorders
- • Lack of consent
About University Of Roma La Sapienza
The University of Roma La Sapienza, one of Italy's premier research institutions, is dedicated to advancing medical science and improving patient outcomes through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, the university harnesses its extensive expertise in diverse fields, including medicine, biotechnology, and public health, to conduct rigorous and ethically sound research. Committed to fostering educational excellence and promoting groundbreaking discoveries, La Sapienza actively engages in clinical trials that aim to address critical health challenges and contribute to the development of new therapeutic interventions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Rome, , Italy
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported