Acute Respiratory FailurePERSIANCT04666246
Inspiratory Effort in COVID-19
An observational study of Acute Respiratory Failure and Covid19, run by University of Modena and Reggio Emilia at 1 site in Italy.
Trial summary
This study aims at assessing esophageal pressure in patients with acute respiratory failure due to COVID-19 undergoing non invasive respiratory support. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Respiratory Failure, Covid19
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2020to 1 Feb 2030
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the Respiratory Intensive Care Unit of the University Hospital of Modena for acute respiratory failure due to COVID-19 pneumonia and candidate to non invasive respiratory support
Who may be able to join
- COVID-19
- Acute respiratory failure undergoing non-invasive respiratory support
Who cannot join
- Need for immediate endotracheal intubation
- Chronic respiratory diseases
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
University Hospital of Modena
Modena, 41124
Alessandro Marchioni, MD, 0039 0594225859, marchioni.alessandro@unimore.it
About this study
Official title: Inspiratory Effort Assessment in Patients With COVID-19 Pneumonia Undergoing Non Invasive Respiratory Support
This study aims at assessing esophageal pressure in patients with acute respiratory failure due to COVID-19 undergoing non invasive respiratory support.
- Conditions
- Acute Respiratory Failure, Covid19
- Keywords
- Acute respiratory failure, Esophageal pressure, Non invasive respiratory support, COVID-19
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Inspiratory effort quantification
Esophageal pressure assessment through dedicated esophageal pressure transducer
Measured: 24 hours from admission
Secondary outcomes (1)
Non invasive respiratory support failure
Reaching of the criteria for endotracheal intubation
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start1 Mar 2020
- Primary completion1 Jun 2024
- Study completion1 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory FailureStudies of the same condition, open and under way.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Modena and Reggio Emilia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Tonelli, University of Modena and Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04666246
- Sponsor's protocol ID
- UModenaReggio17
- Acronym
- PERSIA
- Status last verified
- Apr 2025
- First submitted
- 11 Dec 2020
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inspiratory Effort Assessment in Patients With COVID-19 Pneumonia Undergoing Non Invasive Respiratory Support
- ClinicalTrials.gov ID
- NCT04666246
- Acronym / sponsor ID
- PERSIA / UModenaReggio17
- Conditions
- Acute Respiratory Failure, Covid19
- Keywords
- Acute respiratory failure, Esophageal pressure, Non invasive respiratory support, COVID-19
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Modena and Reggio EmiliaUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Feb 2030 (estimated)
- First posted
- 14 Dec 2020 (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.
This study aims at assessing esophageal pressure in patients with acute respiratory failure due to COVID-19 undergoing non invasive respiratory support.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the Respiratory Intensive Care Unit of the University Hospital of Modena for acute respiratory failure due to COVID-19 pneumonia and candidate to non invasive respiratory support
Key inclusion criteria (2 listed)
- COVID-19
- Acute respiratory failure undergoing non-invasive respiratory support
Key exclusion criteria (2 listed)
- Need for immediate endotracheal intubation
- Chronic respiratory diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Inspiratory effort quantification
Time frame: 24 hours from admission
Esophageal pressure assessment through dedicated esophageal pressure transducer
1 secondary outcome
Non invasive respiratory support failure
Time frame: 24 hours
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 25 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Acute Respiratory Failure
Not yet recruitingObservational study
Diaphragm Response in Elderly for Acute Monitoring
Acute Dyspnea, Acute Respiratory Failure
Not yet recruiting
Modified Inhaled Nitric Oxide in Ventilated Patients With Acute Respiratory Failure
Acute Respiratory Failure (ARF), Nitric Oxide
RecruitingPhase 4
DECONGEST-AHF: Vasodilatation or Loop Diuretics in Acute Heart Failure
Pulmonary Edema, Congestive Heart Failure
RecruitingPhase 2
Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)
Acute Respiratory Distress Syndrome, Infections
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
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 Acute Respiratory Failure and Covid19, run by University of Modena and Reggio Emilia 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 2 inclusion and 2 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 25 Apr 2025. 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?
Contact Roberto Tonelli, MD (0039 0594225934, roberto.tonelli@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inspiratory effort quantification (time frame: 24 hours from admission). 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 25 Apr 2025.