Autonomic Modulation in Patients Undergoing Assisted Mech... | NCT06590311

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

NCT06590311

Sponsor

University of Roma La Sapienza

Status

Not yet recruiting

Last Update Posted

Sep 19, 2024Actual

Enrollment

48Estimated

Phase

Not provided

Conditions

Mechanical Ventilation Weaning

Interventions

Heart Rate Variability

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 15, 2024Estimated

Primary Completion Date

Jun 15, 2025Estimated

Completion Date

Dec 15, 2025Estimated

First Submitted Date

Sep 6, 2024

First Submission Date that Met QC Criteria

Sep 6, 2024

First Posted Date

Sep 19, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 6, 2024

Last Update Posted Date

Sep 19, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

48Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PSV			Diagnostic Test: Heart Rate Variability
PAV+			Diagnostic Test: Heart Rate Variability

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Heart Rate Variability	Diagnostic Test	Heart rate variability evaluation through different domains	PAV+ PSV

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Other domains	To evaluate the difference in other HRV domains between patients assisted in PSV and those assisted in PAV+ at different time points.	30 min to 72 hours
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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Mechanically ventilated ICU patients ready to be weaned

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Giovanni Giordano	Contact	0649978024		gi.giordano@policlinicoumberto1.it

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AOU Policlinico Umberto I		Rome			Italy

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided