Autonomic Modulation in Patients Undergoing Assisted Mechanical Ventilation: Comparison Between PAV+ and PSV

Not yet recruiting

• Conditions: Mechanical Ventilation Weaning
• Interventions: Diagnostic Test: Heart Rate Variability

• Registration Number: NCT06590311
• Lead Sponsor: University of Roma La Sapienza

Brief Summary

The aim of the study is to investigate autonomic modulation in terms of heart rate variability (i.e., HRV) in patients undergoing assisted mechanical ventilation in PSV mode, compared to patients assisted in PAV+ mode. The hypothesis is that the greater patient-ventilator synchrony of the latter mode may represent an advantage in reducing the imbalance of autonomic modulation.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-06
• Study First Submitted QC: 2024-09-06
• Last Update Submitted: 2024-09-06
• Study First Posted: 2024-09-10
• Last Update Posted: 2024-09-10
• Study Start: 2024-09-15
• Primary Completion: 2025-06-15
• Study Completion: 2025-12-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PSV	Heart Rate Variability	-
PAV+	Heart Rate Variability	-

Primary Outcome Measures

Name	Time	Method
LF dominion	30 min	To evaluate the difference in the LF domain between patients assisted in PSV and those assisted in PAV+ at T1 (30 minutes).

Secondary Outcome Measures

Name	Time	Method
Other domains	30 min to 72 hours	To evaluate the difference in other HRV domains between patients assisted in PSV and those assisted in PAV+ at different time points.
Clinical outcomes	28 days	Correlation of HRV parameters with days of assisted ventilation and total ventilation, hospital length of stay (H-LOS) and ICU length of stay (ICU-LOS), mortality, organ dysfunction, delirium, supraventricular and ventricular arrhythmias, etc.

Trial Locations

Locations (1)

AOU Policlinico Umberto I; 🇮🇹 Rome, Italy