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

N/ANot Yet RecruitingNCT06590311

University of Roma La Sapienza48 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Mechanical Ventilation Weaning

Interventions

Heart Rate VariabilityDIAGNOSTIC_TEST

Heart rate variability evaluation through different domains

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

AOU Policlinico Umberto I

Rome, Italy

Outcomes

Primary Outcomes

LF dominion

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

Time frame: 30 min

Secondary Outcomes

Other domains

To evaluate the difference in other HRV domains between patients assisted in PSV and those assisted in PAV+ at different time points.

Time frame: 30 min to 72 hours

Clinical outcomes

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.

Time frame: 28 days

Central Contacts

Giovanni Giordano

CONTACT

0649978024 gi.giordano@policlinicoumberto1.it

Data from ClinicalTrials.gov

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