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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06590311

Enrollment

Registered

2024-09-19

Start date

2024-09-15

Completion date

2025-12-15

Last updated

2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mechanical Ventilation Weaning

Keywords

mechanical ventilation weaning, heart rate variability, autonomic modulation, PAV+

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.

Interventions

DIAGNOSTIC_TESTHeart Rate Variability

Heart rate variability evaluation through different domains

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Italy

Contacts

Primary ContactGiovanni Giordano

gi.giordano@policlinicoumberto1.it0649978024

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026