Noninvasive VentlationDiaCOVIDProneNCT04904731
Effects of Body Position on Diaphragmatic Activity in Patients Requiring Noninvasive Ventilation for Acute Respiratory Failure COVID-19 Related
An observational study of Noninvasive Ventlation and COVID-19 Respiratory Infection, run by Azienda Ospedaliera di Perugia at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Noninvasive Ventlation, COVID-19 Respiratory Infection, Diaphragm Injury
- What is being tested?
- Prone position
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 19 Feb 2021to 24 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- COVID-19 infection,
- Age > 18 years,
- NIV application,
- ICU admission
Who cannot join
- Pregnancy,
- All the conditions contraindicating prone position and NIV
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Being tested
- Prone position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prone positionOther
Patients were assisted in NIV in supine position that was switched in prone position for clinical purpouse
What is being measured
The primary outcome is the main question the study is designed to answer.
Diaphragmatic thickening fraction
The fraction of diaphragmatic thickness variations during respiratory cycle
Measured: At baseline, in supine position
Diaphragmatic thickening fraction
The fraction of diaphragmatic thickness variations during respiratory cycle
Measured: After 1 hour following prone position application
Secondary outcomes (4)
Lung aeration
Lung aeration assessed through sonography
Measured: At baseline, in supine position
Peripheral oxygen saturation
Reflects the grade of peripheral oxygenation
Measured: At baseline, in supine position
Lung aeration
Lung aeration assessed through sonography
Measured: after 1 hour following prone position application
Peripheral oxygen saturation
Reflects the grade of peripheral oxygenation
Measured: after 1 hour following prone position application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start19 Feb 2021
- Primary completion12 May 2021
- Study completion24 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Noninvasive VentlationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera di Perugia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Gianmaria Cammarota, Azienda Ospedaliera di Perugia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04904731
- Sponsor's protocol ID
- 3658/20
- Acronym
- DiaCOVIDProne
- Status last verified
- May 2021
- First submitted
- 24 May 2021
- Last updated
- 27 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: single patients data on motivated request to principal investigator
Publications
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.
PubMed 34429131
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Body Position on Diaphragmatic Activity in Patients Requiring Noninvasive Ventilation for Acute Respiratory Failure COVID-19 Related
- ClinicalTrials.gov ID
- NCT04904731
- Acronym / sponsor ID
- DiaCOVIDProne / 3658/20
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Azienda Ospedaliera di PerugiaUniversity, hospital or other
- Study start
- 19 Feb 2021 (actual)
- Primary completion
- 12 May 2021 (actual)
- Study completion
- 24 May 2021 (actual)
- First posted
- 27 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- COVID-19 infection,
- Age > 18 years,
- NIV application,
- ICU admission
Key exclusion criteria (2 listed)
- Pregnancy,
- All the conditions contraindicating prone position and NIV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prone positionPatients were assisted in NIV in supine position that was switched in prone position for clinical purpouse | Other | – |
Primary outcome
Diaphragmatic thickening fraction
Time frame: At baseline, in supine position
The fraction of diaphragmatic thickness variations during respiratory cycle
Diaphragmatic thickening fraction
Time frame: After 1 hour following prone position application
The fraction of diaphragmatic thickness variations during respiratory cycle
4 secondary outcomes
Lung aeration
Time frame: At baseline, in supine position
Peripheral oxygen saturation
Time frame: At baseline, in supine position
Lung aeration
Time frame: after 1 hour following prone position application
Peripheral oxygen saturation
Time frame: after 1 hour following prone position application
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2021.
- Derived from this study: PubMed 34429131Cammarota 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.
- Individual participant dataSharing planned: Undecided. single patients data on motivated request to principal investigator
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Noninvasive Ventlation and COVID-19 Respiratory Infection, run by Azienda Ospedaliera di Perugia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diaphragmatic thickening fraction (time frame: At baseline, in supine position). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04904731, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2021.