Clinical trial NCT04904731: Effects of Body Position on Diaphragmatic Activity in Patients Requiring Noninvasive Ventilation for Acute Respiratory Failure COVID-19 Related
Official title: Effects of Body Position on Diaphragmatic Activity in Patients Requiring Noninvasive Ventilation for Acute Respiratory Failure COVID-19 Related
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Noninvasive Ventlation
COVID-19 Respiratory Infection
Diaphragm Injury
Lead sponsor: Azienda Ospedaliera di Perugia
Sponsor class: OTHER
First posted: 2021-05-27
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Diaphragmatic thickening fraction
timeFrame: At baseline, in supine position
measure: Diaphragmatic thickening fraction
timeFrame: After 1 hour following prone position application
Secondary outcomes:
measure: Lung aeration
timeFrame: At baseline, in supine position
measure: Peripheral oxygen saturation
timeFrame: At baseline, in supine position
measure: Lung aeration
timeFrame: after 1 hour following prone position application
measure: Peripheral oxygen saturation
timeFrame: after 1 hour following prone position application
Other outcomes:
Locations:
city: Perugia
country: Italy
facility: Gianmaria Cammarota
state: Umbria
Study officials:
References:
citation: 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.