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

NCT ID: NCT04904731

Last Updated: 2021-05-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-19

Study Completion Date

2021-05-24

Brief Summary

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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

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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.

Conditions

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Noninvasive Ventlation COVID-19 Respiratory Infection Diaphragm Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Prone position

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Pregnancy,
* All the conditions contraindicating prone position and NIV
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliera di Perugia

OTHER

Sponsor Role lead

Responsible Party

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Prof Gianmaria Cammarota

Associate Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Gianmaria Cammarota

Perugia, Umbria, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 34429131 (View on PubMed)

Other Identifiers

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3658/20

Identifier Type: -

Identifier Source: org_study_id

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