Inspiratory Effort in COVID-19 | NCT04666246

Studies
Inspiratory Effort in COVID-19

NCT04666246

Sponsor

University of Modena and Reggio Emilia

Status

Recruiting

Last Update Posted

Apr 25, 2025Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Acute Respiratory Failure
Covid19

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2020Actual

Primary Completion Date

Jun 1, 2024Actual

Completion Date

Feb 1, 2030Estimated

First Submitted Date

Dec 11, 2020

First Submission Date that Met QC Criteria

Dec 11, 2020

First Posted Date

Dec 14, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 24, 2025

Last Update Posted Date

Apr 25, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Inspiratory effort quantification	Esophageal pressure assessment through dedicated esophageal pressure transducer	24 hours from admission

Secondary Outcomes

Measure	Description	Time Frame
Non invasive respiratory support failure	Reaching of the criteria for endotracheal intubation	24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Need for immediate endotracheal intubation
Chronic respiratory diseases

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder 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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

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

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Modena	Recruiting	Modena		41124	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided