Effects of Body Position on Diaphragmatic Activity in Patients Requiring Noninvasive Ventilation for Acute Respiratory Failure COVID-19 Related
DiaCOVIDProne
1 other identifier
observational
24
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 19, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 12, 2021
CompletedFirst Submitted
Initial submission to the registry
May 24, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 24, 2021
CompletedFirst Posted
Study publicly available on registry
May 27, 2021
CompletedMay 27, 2021
May 1, 2021
3 months
May 24, 2021
May 25, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Diaphragmatic thickening fraction
The fraction of diaphragmatic thickness variations during respiratory cycle
At baseline, in supine position
Diaphragmatic thickening fraction
The fraction of diaphragmatic thickness variations during respiratory cycle
After 1 hour following prone position application
Secondary Outcomes (4)
Lung aeration
At baseline, in supine position
Peripheral oxygen saturation
At baseline, in supine position
Lung aeration
after 1 hour following prone position application
Peripheral oxygen saturation
after 1 hour following prone position application
Interventions
Patients were assisted in NIV in supine position that was switched in prone position for clinical purpouse
Eligibility Criteria
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.
You may qualify if:
- COVID-19 infection,
- Age \> 18 years,
- NIV application,
- ICU admission
You may not qualify if:
- Pregnancy,
- All the conditions contraindicating prone position and NIV
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gianmaria Cammarota
Perugia, Umbria, 06156, Italy
Related Publications (1)
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.
PMID: 34429131DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Clinical Professor
Study Record Dates
First Submitted
May 24, 2021
First Posted
May 27, 2021
Study Start
February 19, 2021
Primary Completion
May 12, 2021
Study Completion
May 24, 2021
Last Updated
May 27, 2021
Record last verified: 2021-05