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

COVID-19 Respiratory Infection Clinical Trial

— DiaCOVIDProne  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04904731
• Other study ID #: 3658/20
• Status: Completed
• Start date: February 19, 2021
• Est. completion date: May 24, 2021

Study information

• Verified date: May 2021
• Source: Azienda Ospedaliera di Perugia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 24, 2021
• Est. primary completion date: May 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Diaphragm Injury
• Respiratory Insufficiency
• Respiratory Tract Infections

Intervention

Other:
• Prone position
Patients were assisted in NIV in supine position that was switched in prone position for clinical purpouse

Locations

Country	Name	City	State
Italy	Gianmaria Cammarota	Perugia	Umbria

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera di Perugia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diaphragmatic thickening fraction	The fraction of diaphragmatic thickness variations during respiratory cycle	At baseline, in supine position
Primary	Diaphragmatic thickening fraction	The fraction of diaphragmatic thickness variations during respiratory cycle	After 1 hour following prone position application
Secondary	Lung aeration	Lung aeration assessed through sonography	At baseline, in supine position
Secondary	Peripheral oxygen saturation	Reflects the grade of peripheral oxygenation	At baseline, in supine position
Secondary	Lung aeration	Lung aeration assessed through sonography	after 1 hour following prone position application
Secondary	Peripheral oxygen saturation	Reflects the grade of peripheral oxygenation	after 1 hour following prone position application