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

U

University of Roma La Sapienza

Status

Not yet enrolling

Conditions

Mechanical Ventilation Weaning

Treatments

Diagnostic Test: Heart Rate Variability

Study type

Observational

Funder types

Other

Identifiers

NCT06590311
RIA24.2

Details and patient eligibility

About

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.

Enrollment

48 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

48 participants in 2 patient groups

PSV
Treatment:
Diagnostic Test: Heart Rate Variability
PAV+
Treatment:
Diagnostic Test: Heart Rate Variability

Trial contacts and locations

1

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Central trial contact

Giovanni Giordano

Data sourced from clinicaltrials.gov

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