NCT04666246

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
46mo left

Started Mar 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
Mar 2020Feb 2030

Study Start

First participant enrolled

March 1, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 14, 2020

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
5.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2030

Expected
Last Updated

April 25, 2025

Status Verified

April 1, 2025

Enrollment Period

4.3 years

First QC Date

December 11, 2020

Last Update Submit

April 24, 2025

Conditions

Acute Respiratory FailureCovid19

Keywords

Acute respiratory failureEsophageal pressureNon invasive respiratory supportCOVID-19

Outcome Measures

Primary Outcomes (1)

  • Inspiratory effort quantification

    Esophageal pressure assessment through dedicated esophageal pressure transducer

    24 hours from admission

Secondary Outcomes (1)

  • Non invasive respiratory support failure

    24 hours

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • Need for immediate endotracheal intubation
  • Chronic respiratory diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Modena

Modena, 41124, Italy

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Roberto Tonelli, MD

CONTACT

0039 0594225934roberto.tonelli@me.com

Alessandro Marchioni, MD

CONTACT

0039 0594225859marchioni.alessandro@unimore.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 11, 2020

First Posted

December 14, 2020

Study Start

March 1, 2020

Primary Completion

June 1, 2024

Study Completion (Estimated)

February 1, 2030

Last Updated

April 25, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)