Mechanical Ventilation WeaningNCT06590311
Autonomic Modulation in Patients Undergoing Assisted Mechanical Ventilation: Comparison Between PAV+ and PSV
An observational study of Mechanical Ventilation Weaning, run by University of Roma La Sapienza at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation Weaning
- What is being tested?
- Heart Rate Variability
- How many people
- 48 participants
- Where
- 1 siteItaly
- Study dates
- 15 Sep 2024to 15 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Mechanically ventilated ICU patients ready to be weaned
Who may be able to join
- 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.
Who cannot join
- 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
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- Severe head trauma, dementia
- High spinal cord injury
- Neuromuscular disorders
- Lack of consent
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Heart Rate Variability
- Keywords
- mechanical ventilation weaning, heart rate variability, autonomic modulation, PAV+
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart Rate VariabilityDiagnostic test
Heart rate variability evaluation through different domains
| Study group | Role | What they receive |
|---|---|---|
| PSV | Not described Receives: Diagnostic Test: Heart Rate Variability | |
| PAV+ | Not described Receives: Diagnostic Test: Heart Rate Variability |
What is being measured
The primary outcome is the main question the study is designed to answer.
LF dominion
To evaluate the difference in the LF domain between patients assisted in PSV and those assisted in PAV+ at T1 (30 minutes).
Measured: 30 min
Secondary outcomes (2)
Other domains
To evaluate the difference in other HRV domains between patients assisted in PSV and those assisted in PAV+ at different time points.
Measured: 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.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 Sep 2024 (estimated)
- Primary completion15 Jun 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Ventilation WeaningStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Alessandri, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06590311
- Sponsor's protocol ID
- RIA24.2
- Status last verified
- Sep 2024
- First submitted
- 6 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autonomic Modulation in Patients Undergoing Assisted Mechanical Ventilation: Comparison Between PAV+ and PSV
- ClinicalTrials.gov ID
- NCT06590311
- Acronym / sponsor ID
- RIA24.2
- Conditions
- Mechanical Ventilation Weaning
- Keywords
- mechanical ventilation weaning, heart rate variability, autonomic modulation, PAV+
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 15 Sep 2024 (estimated)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PSV | – | Diagnostic Test: Heart Rate Variability |
| PAV+ | – | Diagnostic Test: Heart Rate Variability |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mechanically ventilated ICU patients ready to be weaned
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart Rate VariabilityHeart rate variability evaluation through different domains | Diagnostic test | PAV+, PSV |
Primary outcome
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).
2 secondary outcomes
Other domains
Time frame: 30 min to 72 hours
Clinical outcomes
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Ventilation Weaning, run by University of Roma La Sapienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Giovanni Giordano (0649978024, gi.giordano@policlinicoumberto1.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LF dominion (time frame: 30 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.