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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

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

Keywords

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

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Need for immediate endotracheal intubation
  • Chronic respiratory diseases
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No
05

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

06

Study locations

1 of 1 sites recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

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 ↗

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