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NCT Number: NCT06590311

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

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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Key information

Conditions

Mechanical Ventilation Weaning

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AOU Policlinico Umberto I

Rome, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Heart Rate Variability

Diagnostic Test

Heart rate variability evaluation through different domains

Primary outcomes

  1. LF dominion

    Time frame: 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 outcomes

  1. Other domains

    Time frame: 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.

  2. Clinical outcomes

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Giovanni Giordano

CONTACT

[email protected]

0649978024

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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