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

Completed

• Conditions: Noninvasive Ventlation; Diaphragm Injury; COVID-19 Respiratory Infection

• Registration Number: NCT04904731
• Lead Sponsor: Azienda Ospedaliera di Perugia

Brief 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

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 Timeline

• Study Start: 2021-02-19
• Status Verified: 2021-05
• Primary Completion: 2021-05-12
• Study Completion: 2021-05-24
• Study First Submitted: 2021-05-24
• Study First Submitted QC: 2021-05-25
• Last Update Submitted: 2021-05-25
• Study First Posted: 2021-05-27
• Last Update Posted: 2021-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diaphragmatic thickening fraction	After 1 hour following prone position application	The fraction of diaphragmatic thickness variations during respiratory cycle

Secondary Outcome Measures

Name	Time	Method
Lung aeration	after 1 hour following prone position application	Lung aeration assessed through sonography
Peripheral oxygen saturation	after 1 hour following prone position application	Reflects the grade of peripheral oxygenation

Trial Locations

Locations (1)

Gianmaria Cammarota; 🇮🇹 Perugia, Umbria, Italy