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

NCT06590311 | Not Yet Recruiting

• 1 other identifier: RIA24.2
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mechanical Ventilation Weaning

Keywords

mechanical ventilation weaning; heart rate variability; autonomic modulation; PAV+

Outcome Measures

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).

  30 min

Secondary Outcomes (2)

• Other domains

  30 min to 72 hours

• Clinical outcomes

  28 days

Study Arms (2)

PSV

Diagnostic Test: Heart Rate Variability

PAV+

Diagnostic Test: Heart Rate Variability

Interventions

Heart Rate Variability DIAGNOSTIC_TEST

Heart rate variability evaluation through different domains

PAV+; PSV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Mechanically ventilated ICU patients ready to be weaned

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

AOU Policlinico Umberto I

Rome, Italy

Location

Central Study Contacts

Giovanni Giordano

CONTACT

0649978024; gi.giordano@policlinicoumberto1.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: September 15, 2024
• Primary Completion: June 15, 2025
• Study Completion: December 15, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

IT (1)