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

Other: Prone position

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)

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

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

Cammarota G, Rossi E, Vitali L, Simonte R, Sannipoli T, Anniciello F, Vetrugno L, Bignami E, Becattini C, Tesoro S, Azzolina D, Giacomucci A, Navalesi P, De Robertis E. Effect of awake prone position on diaphragmatic thickening fraction in patients assisted by noninvasive ventilation for hypoxemic acute respiratory failure related to novel coronavirus disease. Crit Care. 2021 Aug 24;25(1):305. doi: 10.1186/s13054-021-03735-x.

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)