ClinicalTrials.gg
Sign In
RecruitingNCT04666246PERSIAUpdated Apr 25, 2025

Inspiratory Effort in COVID-19

An observational study in Acute Respiratory Failure and Covid19, sponsored by University of Modena and Reggio Emilia. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-04-25.

Sponsored by University of Modena and Reggio Emilia · Observational

From the registry’s dates

  • Started Mar 2020; still recruiting 6 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
18 Years to 80 Years
Sex
All
01

Study summary

This study aims at assessing esophageal pressure in patients with acute respiratory failure due to COVID-19 undergoing non invasive respiratory support.

02

Conditions studied

  • Acute Respiratory Failure
  • Covid19

Browse trials for

Keywords

  • Acute respiratory failure
  • Esophageal pressure
  • Non invasive respiratory support
  • COVID-19
03

In context

COVID-19

7,990 studies on the registry are indexed under COVID-19; 466 are open to participants now.

This study's planned enrollment of 40 is below the median of 268 across 3,208 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

University of Modena and Reggio Emilia is the lead sponsor of 65 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • COVID-19
  • Acute respiratory failure undergoing non-invasive respiratory support

Exclusion criteria

Exclusion Criteria:

  • Need for immediate endotracheal intubation
  • Chronic respiratory diseases
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Inspiratory effort quantification

    Esophageal pressure assessment through dedicated esophageal pressure transducer

    Time frame: 24 hours from admission

Secondary outcomes

  1. Non invasive respiratory support failure

    Reaching of the criteria for endotracheal intubation

    Time frame: 24 hours

07

Study locations

1 of 1 sites recruiting
  • University Hospital of Modena
    Modena, 41124, Italy
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2020 to primary completion in Jun 2024, 51 months.

Of 1,640 non-industry observational studies under COVID-19, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 30. This study's 51 months is above that.

Counting every sponsor, half of 1,774 studies reached it within 13 months; a quarter within 5 and three quarters within 29.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 11, 2020
First posted
Dec 14, 2020
StartActual
Mar 1, 2020
Primary completionActual
Jun 1, 2024
CompletionEst.
Feb 1, 2030
Last update
Apr 25, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04666246
Lead sponsor
University of Modena and Reggio Emilia
Responsible party
Roberto Tonelli (MD, University of Modena and Reggio Emilia) — Principal investigator
First posted
Dec 14, 2020
Start date
Mar 1, 2020
Primary completion
Jun 1, 2024
Completion
Feb 1, 2030 (estimated)
Last update
Apr 25, 2025

Study contacts

Roberto Tonelli, MD
Contact
roberto.tonelli@me.com
0039 0594225934
Alessandro Marchioni, MD
Contact
marchioni.alessandro@unimore.it
0039 0594225859

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

COVID-19 →

Other studies from this sponsor

University of Modena and Reggio Emilia

Start the discussion