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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Roma La Sapienza

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial population

Mechanically ventilated ICU patients ready to be weaned

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Heart Rate Variability

    Diagnostic test

    Heart rate variability evaluation through different domains

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: PSV1 intervention
Group B: PAV+1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

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

Other outcomes

Sponsors and contacts

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