Effects of Body Position on Diaphragmatic Activity in Patients Requiring Noninvasive Ventilation for Acute Respiratory Failure COVID-19 Related (DiaCOVIDProne)

May 25, 2021 updated by: Prof Gianmaria Cammarota, Azienda Ospedaliera di Perugia
The present investigation aims to assess the diaphragmatic thickening fraction, reflecting the diaphragmatic activity, during supine (baseline) and at 1 hour following prone position in patients assisted through non invasive ventilation due to hypoxemic acute respiratory failure related to COVID-19. Also, the impact of lung aeration and comfort were ascertained in the same setting

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Primary aim is to asses the effects of body position on diaphragmatic thickening fraction (primary aim) and lung aeration and vital sign (secondary aims) in patents assisted via noninvasive ventilation (NIV) for hypoxemic acute respiratory failure (hARF) associated to COVID-19. All adult patients, admitted for hARF due to COVID-19 and requiring NIV were enrolled.

Diaphragmatic thickening fraction, lung aeration assessed through ultrasound, comfort, and grade of sedation-agitation as well as vital signs, i.e., peripheral oxygen saturation, blood pressure, and breathing pattern were monitored during noninvasive ventilation in supine and after 1 hour following the switch to prone position.

Study Type

Observational

Enrollment (Actual)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Umbria
      • Perugia, Umbria, Italy, 06156
        • Gianmaria Cammarota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult patient, admitted to intensive care unit for hypoxemic acute respiratory failure associated to COVID-19 requiring NIV, who were subjected to prone position for clinical purpouse.

Description

Inclusion Criteria:

  • COVID-19 infection,
  • Age > 18 years,
  • NIV application,
  • ICU admission

Exclusion Criteria:

  • Pregnancy,
  • All the conditions contraindicating prone position and NIV

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diaphragmatic thickening fraction
Time Frame: At baseline, in supine position
The fraction of diaphragmatic thickness variations during respiratory cycle
At baseline, in supine position
Diaphragmatic thickening fraction
Time Frame: After 1 hour following prone position application
The fraction of diaphragmatic thickness variations during respiratory cycle
After 1 hour following prone position application

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lung aeration
Time Frame: At baseline, in supine position
Lung aeration assessed through sonography
At baseline, in supine position
Peripheral oxygen saturation
Time Frame: At baseline, in supine position
Reflects the grade of peripheral oxygenation
At baseline, in supine position
Lung aeration
Time Frame: after 1 hour following prone position application
Lung aeration assessed through sonography
after 1 hour following prone position application
Peripheral oxygen saturation
Time Frame: after 1 hour following prone position application
Reflects the grade of peripheral oxygenation
after 1 hour following prone position application

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera di Perugia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2021

Primary Completion (Actual)

May 12, 2021

Study Completion (Actual)

May 24, 2021

Study Registration Dates

First Submitted

May 24, 2021

First Submitted That Met QC Criteria

May 25, 2021

First Posted (Actual)

May 27, 2021

Study Record Updates

Last Update Posted (Actual)

May 27, 2021

Last Update Submitted That Met QC Criteria

May 25, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3658/20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

single patients data on motivated request to principal investigator

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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