Mechanical PowerNCT06425354
Use of 'Mechanical Power' as a Predictor of Increased Serum and Pulmonary Proinflammatory Cytokine Concentrations in Patients With Acute Hypoxemic Respiratory Failure: A Prospective Observational Study
An observational study of Mechanical Power, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
The aim of this study is to report the proportion of patients with acute hypoxemic respiratory failyre (AHRF) undergoing mechanical ventilation who exceed 17 J/min of mechanical power (MP) and the difference in terms of proinflammatory cytokine concentration in blood samples and bronchoalveolar lavage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Power
- What is being tested?
- Mechanical ventilation
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 15 Apr 2023to 15 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients with AHRF undergoing mechanical ventilation
Who may be able to join
- Patients with AHRF (P/F <300 mmHg) undergoing invasive mechanical ventilation within 7 days from the onset of symptoms
- Invasive mechanical ventilation for less than 6 hours
- Evidence of newly developed lung consolidation on chest imaging (X-ray, CT)
- Age ≥18 years
Who cannot join
- Prior invasive mechanical ventilation during the same hospitalization
- Tracheostomy
- Severe anemia (Hb<7g/dL)
- Severe neutropenia
- Renal insufficiency or RRT (Renal Replacement Therapy)
- Noradrenaline >0.5 mcg/kg/min
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- Pregnancy
- Extracorporeal circulation (ECCO2R, ECMO)
- Life expectancy <24 hours as clinically judged
- Lack of consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Sapienza University of Rome
Roma, 00161
Francesco Alessandri, 0039 0649978924, f.alessandri@uniroma1.it
Giovanni Giordano
About this study
The aim of this study is to report the proportion of patients with acute hypoxemic respiratory failyre (AHRF) undergoing mechanical ventilation who exceed 17 J/min of mechanical power (MP) and the difference in terms of proinflammatory cytokine concentration in blood samples and bronchoalveolar lavage.
The main questions it aims to answer are:
Read more
- Which is the proportion of patients who exceed 17 J/min of mechanical power (MP) during the first 72 hours of mechanical ventilation?
- Is there a difference in terms of cytokine concentration in patients undergoing mechanical power >17 J/min compared to <17 J/min?
Patients will be divided into two groups based on respiratory mechanics measurements: low MP group (average MP <17 J/min) and high MP group (average MP ≥17 J/min). The researchers will collect blood and BAL samples and perform cytokine assays.
- Conditions
- Mechanical Power
- Being tested
- Mechanical ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical ventilationDevice
Mechanical ventilatiom
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients who exceed 17 J/min of MP
Proportion of patients with AHRF undergoing mechanical ventilation who exceed 17 J/min of MP
Measured: 4 years
Secondary outcomes (1)
Inflammatory cytokines
Difference in terms of proinflammatory cytokine concentration in blood samples and bronchoalveolar lavage.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2024
- Study start15 Apr 2023
- Primary completion15 Apr 2027 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical PowerStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 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
- NCT06425354
- Sponsor's protocol ID
- RIA24.1
- Status last verified
- May 2024
- First submitted
- 17 May 2024
- Last updated
- 22 May 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 22 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of 'Mechanical Power' as a Predictor of Increased Serum and Pulmonary Proinflammatory Cytokine Concentrations in Patients With Acute Hypoxemic Respiratory Failure: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT06425354
- Acronym / sponsor ID
- RIA24.1
- Conditions
- Mechanical Power
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 15 Apr 2027 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 22 May 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 this study is to report the proportion of patients with acute hypoxemic respiratory failyre (AHRF) undergoing mechanical ventilation who exceed 17 J/min of mechanical power (MP) and the difference in terms of proinflammatory cytokine concentration in blood samples and bronchoalveolar lavage.
The main questions it aims to answer are:
- Which is the proportion of patients who exceed 17 J/min of mechanical power (MP) during the first 72 hours of mechanical ventilation?
- Is there a difference in terms of cytokine concentration in patients undergoing mechanical power >17 J/min compared to <17 J/min?
Patients will be divided into two groups based on respiratory mechanics measurements: low MP group (average MP <17 J/min) and high MP group (average MP ≥17 J/min). The researchers will collect blood and BAL samples and perform cytokine assays.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with AHRF undergoing mechanical ventilation
Key inclusion criteria (4 listed)
- Patients with AHRF (P/F <300 mmHg) undergoing invasive mechanical ventilation within 7 days from the onset of symptoms
- Invasive mechanical ventilation for less than 6 hours
- Evidence of newly developed lung consolidation on chest imaging (X-ray, CT)
- Age ≥18 years
Key exclusion criteria (10 listed)
- Prior invasive mechanical ventilation during the same hospitalization
- Tracheostomy
- Severe anemia (Hb<7g/dL)
- Severe neutropenia
- Renal insufficiency or RRT (Renal Replacement Therapy)
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 |
|---|---|---|
| Mechanical ventilationMechanical ventilatiom | Device | – |
Primary outcome
Patients who exceed 17 J/min of MP
Time frame: 4 years
Proportion of patients with AHRF undergoing mechanical ventilation who exceed 17 J/min of MP
1 secondary outcome
Inflammatory cytokines
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 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.
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 Power, 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 4 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: looking for participants now, as of the sponsor's last update on 22 May 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients who exceed 17 J/min of MP (time frame: 4 years). 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 22 May 2024.