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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-09-15

Study Completion Date

2025-12-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Mechanical Ventilation Weaning

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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PSV

Heart Rate Variability

Intervention Type DIAGNOSTIC_TEST

Heart rate variability evaluation through different domains

PAV+

Heart Rate Variability

Intervention Type DIAGNOSTIC_TEST

Heart rate variability evaluation through different domains

Interventions

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Heart Rate Variability

Heart rate variability evaluation through different domains

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No