Skip to main content
OpenTrials
Completed

NCT Number: NCT04904731

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Noninvasive Ventlation COVID-19 Respiratory Infection Diaphragm Injury

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gianmaria Cammarota

Perugia, Umbria, 06156, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Prone position

Other

Patients were assisted in NIV in supine position that was switched in prone position for clinical purpouse

Primary outcomes

  1. Diaphragmatic thickening fraction

    Time frame: At baseline, in supine position

    The fraction of diaphragmatic thickness variations during respiratory cycle

  2. Diaphragmatic thickening fraction

    Time frame: After 1 hour following prone position application

    The fraction of diaphragmatic thickness variations during respiratory cycle

Secondary outcomes

  1. Lung aeration

    Time frame: At baseline, in supine position

    Lung aeration assessed through sonography

  2. Peripheral oxygen saturation

    Time frame: At baseline, in supine position

    Reflects the grade of peripheral oxygenation

  3. Lung aeration

    Time frame: after 1 hour following prone position application

    Lung aeration assessed through sonography

  4. Peripheral oxygen saturation

    Time frame: after 1 hour following prone position application

    Reflects the grade of peripheral oxygenation

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera di Perugia

Other

Registry information

Acronym: DiaCOVIDProne

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 27, 2021
Registry last updated
May 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.