CClinicalTrials.gg
CompletedNCT04904731DiaCOVIDProneUpdated May 27, 2021

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

An observational study in Noninvasive Ventlation, COVID-19 Respiratory Infection and Diaphragm Injury, sponsored by Azienda Ospedaliera di Perugia. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-05-27.

Sponsored by Azienda Ospedaliera di Perugia · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
24
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Noninvasive Ventlation
  • COVID-19 Respiratory Infection
  • Diaphragm Injury
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 24 is below the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Azienda Ospedaliera di Perugia is the lead sponsor of 13 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Pregnancy,
  • All the conditions contraindicating prone position and NIV
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
24 participants (actual)
Patient registry
No

Interventions

  • OtherProne position

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

06

What researchers measure

Primary outcomes

  1. Diaphragmatic thickening fraction

    The fraction of diaphragmatic thickness variations during respiratory cycle

    Time frame: At baseline, in supine position

  2. Diaphragmatic thickening fraction

    The fraction of diaphragmatic thickness variations during respiratory cycle

    Time frame: After 1 hour following prone position application

Secondary outcomes

  1. Lung aeration

    Lung aeration assessed through sonography

    Time frame: At baseline, in supine position

  2. Peripheral oxygen saturation

    Reflects the grade of peripheral oxygenation

    Time frame: At baseline, in supine position

  3. Lung aeration

    Lung aeration assessed through sonography

    Time frame: after 1 hour following prone position application

  4. Peripheral oxygen saturation

    Reflects the grade of peripheral oxygenation

    Time frame: after 1 hour following prone position application

07

Study locations

1 site
  • Gianmaria Cammarota
    Perugia, Umbria 06156, Italy
08

References and documents

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. PubMed 34429131 ↗

Individual participant data

Plan to share: Undecided — single patients data on motivated request to principal investigator

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 27, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04904731
Lead sponsor
Azienda Ospedaliera di Perugia
Responsible party
Prof Gianmaria Cammarota (Associate Clinical Professor, Azienda Ospedaliera di Perugia) — Principal investigator
First posted
May 27, 2021
Start date
Feb 19, 2021
Primary completion
May 12, 2021
Completion
May 24, 2021
Last update
May 27, 2021

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion