Acute Respiratory FailureNCT05209477
Effects of Body Position and Recruiting Maneuver on Lung Aeration Assessed Through Ultrasound in Patients Intubated for Acute Respiratory Failure Related to Novel Coronavirus 19 Disease
A study testing lung ultrasound assessment in people with Acute Respiratory Failure, run by Azienda Ospedaliera di Perugia at 1 site in Italy.
Trial summary
Second analysis of data prospectively collected during an investigation assessing the clinical characteristics of patients admitted for hypoxemic acute respiratory failure (hARF) related to novel coronavirus 19 disease (COVID-19). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Failure
- What is being tested?
- lung ultrasound assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2021to 31 May 2022
- Phase
- Interventional
- 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
Who may be able to join
- Exclusion Criteria: Any contraindication to recruitment and lung ultrasound, pregnancy
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Second analysis of data prospectively collected during an investigation assessing the clinical characteristics of patients admitted for hypoxemic acute respiratory failure (hARF) related to novel coronavirus 19 disease (COVID-19). In particular, the primary aim of the present analysis is to assess the effects of recruiting maneuver and prone positioning on lung aeration evaluated through lung ultrasound in patients undergoing invasive mechanical ventilation
- Conditions
- Acute Respiratory Failure
- Being tested
- lung ultrasound assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lung ultrasound assessmentOther
In patients undergoing invasive mechanical ventilation with an arterial oxygen tension on inspired oxygen fraction ratio < 200 mmHg requiring recruitment maneuver and prone positioning as a rescue therapy, lung aeration will be evaluated at:
- baseline, in supine position under protective ventilation
- after two minute of recruitment maneuver in pressure controlled ventilation
- at 1 hour following prone positioning application
| Study group | Role | What they receive |
|---|---|---|
| Lung ultrasound | Other | n patients undergoing invasive mechanical ventilation with an arterial oxygen tension on inspired oxygen fraction ratio < 200 mmHg requiring recruitment maneuver and prone positioning as a rescue therapy, lung aeration will be evaluated at:
baseline, in supine position under protective ventilation after two minute of recruitment maneuver in pressure controlled ventilation at 1 hour following prone positioning application Receives: Other: lung ultrasound assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
lung ultrasound score
lung aeration evaluated through ultrasound during protective invasive mechanical in supine position. Lung ultrasound score ranges from a minimum of 0 to a maximum of 36, where 0 is the best lung aeration and 36 is the worst lung aeration
Measured: after 20 minutes following study entry, in volume controll ventilation and supine position
lung ultrasound score recruitment
lung aeration evaluated through ultrasound during protective invasive mechanical ventilation in supine position after two minutes of recruiting maneuver in pressure controlled ventilation. Lung ultrasound score ranges from a minimum of 0 to a maximum of 36, where 0 is the best lung aeration and 36 is the worst lung aeration
Measured: 2 minutes
lung ultrasound score prone positioning
lung aeration evaluated through ultrasound during protective invasive mechanical ventilation after 1 h from prone position application. Lung ultrasound score ranges from a minimum of 0 to a maximum of 36, where 0 is the best lung aeration and 36 is the worst lung aeration
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2022
- Study start1 Dec 2021
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory FailureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 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
- NCT05209477
- Sponsor's protocol ID
- 12/21
- Status last verified
- Jan 2024
- First submitted
- 13 Jan 2022
- Last updated
- 31 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Body Position and Recruiting Maneuver on Lung Aeration Assessed Through Ultrasound in Patients Intubated for Acute Respiratory Failure Related to Novel Coronavirus 19 Disease
- ClinicalTrials.gov ID
- NCT05209477
- Acronym / sponsor ID
- 12/21
- Conditions
- Acute Respiratory Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Azienda Ospedaliera di PerugiaUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 26 Jan 2022 (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.
Second analysis of data prospectively collected during an investigation assessing the clinical characteristics of patients admitted for hypoxemic acute respiratory failure (hARF) related to novel coronavirus 19 disease (COVID-19). In particular, the primary aim of the present analysis is to assess the effects of recruiting maneuver and prone positioning on lung aeration evaluated through lung ultrasound in patients undergoing invasive mechanical ventilation
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung ultrasound | Other | Other: lung ultrasound assessmentn patients undergoing invasive mechanical ventilation with an arterial oxygen tension on inspired oxygen fraction ratio < 200 mmHg requiring recruitment maneuver and prone positioning as a rescue therapy, lung aeration will be evaluated at: baseline, in supine position under protective ventilation after two minute of recruitment maneuver in pressure controlled ventilation at 1 hour following prone positioning application |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Exclusion Criteria: Any contraindication to recruitment and lung ultrasound, pregnancy
- -
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| lung ultrasound assessmentIn patients undergoing invasive mechanical ventilation with an arterial oxygen tension on inspired oxygen fraction ratio < 200 mmHg requiring recruitment maneuver and prone positioning as a rescue therapy, lung aeration will be evaluated at: 1. baseline, in supine position under protective ventilation 2. after two minute of recruitment maneuver in pressure controlled ventilation 3. at 1 hour following prone positioning application | Other | Lung ultrasound |
Primary outcome
lung ultrasound score
Time frame: after 20 minutes following study entry, in volume controll ventilation and supine position
lung aeration evaluated through ultrasound during protective invasive mechanical in supine position. Lung ultrasound score ranges from a minimum of 0 to a maximum of 36, where 0 is the best lung aeration and 36 is the worst lung aeration
lung ultrasound score recruitment
Time frame: 2 minutes
lung aeration evaluated through ultrasound during protective invasive mechanical ventilation in supine position after two minutes of recruiting maneuver in pressure controlled ventilation. Lung ultrasound score ranges from a minimum of 0 to a maximum of 36, where 0 is the best lung aeration and 36 is the worst lung aeration
lung ultrasound score prone positioning
Time frame: 1 hour
lung aeration evaluated through ultrasound during protective invasive mechanical ventilation after 1 h from prone position application. Lung ultrasound score ranges from a minimum of 0 to a maximum of 36, where 0 is the best lung aeration and 36 is the worst lung aeration
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 31 Jan 2024.
- Individual participant dataSharing planned: Undecided
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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?
A study testing lung ultrasound assessment in people with Acute Respiratory Failure, 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 2 inclusion and 0 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 31 Jan 2024. 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?
lung ultrasound score (time frame: after 20 minutes following study entry, in volume controll ventilation and supine position). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jan 2024.