ARDS, HumanNCT04605133
Electrical Impedance Tomography Monitoring and Invasive Mechanical Ventilation During Pronation in Acute Respiratory Distress Syndrome.
An observational study of ARDS, Human, run by Azienda Sanitaria-Universitaria Integrata di Udine at 1 site in Italy.
Trial summary
Acute respiratory distress syndrome is an acute form of lung injury. The most commonly used classification criteria for this syndrome are Berlin's Criteria. The actual literature underlines the advantages of prone position in mild or severe forms of ARDS in association with invasive mechanical ventilation. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- ARDS, Human
- What is being tested?
- Electrical impedance tomography
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2020to 31 Dec 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients' anthropometric data were collected. Ventilation parameters, electric impedence tomography parameters and blood gas analysis values were collected four times: patient supine (T0), one hour after pronation (T1), sixteen hours after pronation (T2), one hour after supination (T3).
Who may be able to join
- mild or severe ARDS according to Berlin's Criteria
- recruitment maximum 72 hours from the diagnosis of ARDS
Who cannot join
- other non-ARDS respiratory system pathologies
- hemodynamic instability (mean arterial pressure < 60 mmHg)
- pneumothorax
- endocranial hypertension
- skin lesions or burns
- presence of pacemaker or implantable defibrillator
- pregnancy
Trial locations and contacts
1 site in 1 country.
Italy1 site
Anesthesiology and Intensive Care Clinic - Department of Medicine - ASUIUD
Udine, 33100
About this study
Acute respiratory distress syndrome is an acute form of lung injury. The most commonly used classification criteria for this syndrome are Berlin's Criteria. The actual literature underlines the advantages of prone position in mild or severe forms of ARDS in association with invasive mechanical ventilation. The hypothesis of this study is to investigate the effective ventilation and perfusion modifications during pronation assessed with clinical parameters and with the aid of the electrical impedance tomography.
- Conditions
- ARDS, Human
- Being tested
- Electrical impedance tomography
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical impedance tomographyDevice
Every patient is monitored with electrical impedance tomograpy before, during and after prone position.
| Study group | Role | What they receive |
|---|---|---|
| ARDS | Patients with mild or severe ARDS necessitating of prone position during mechanical ventilation Receives: Device: Electrical impedance tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pronation and Regions of Interest increase in percentage
Demonstrate that pronation, without any recruitment maneuver, augments the dorsal regions of interest of 5%.
Measured: 1 hour after supination
Secondary outcomes (4)
PaO2/FiO2 ratio and ventral/dorsal Regions of Interest ratio
Obtain a statistical significant increase of PaO2/FiO2 ratio, with a consensual decrease of the ventral/dorsal Region of Interest ratio. It'a a measure of the difference between two ratios.
Measured: 1 hour after supination
Homogeneity of the ventral and dorsal regions from 0 to 1
Verify in which of the 4 measurements (T0-T1-T2-T3) the ventral/dorsal Region of Interest ratio is closer to 1, which means a complete homogeneity of the ventral and dorsal regions.
Measured: 1 hour after supination
Region of Interest ratio and days of mechanical ventilation.
Understand if there is an association between ROI ratio and the days of mechanical ventilation.
Measured: 30 days after pronation
Region of Interest ratio and length of stay in intensive care unit
Understand if there is an association between ROI ratio and the length of stay in intensive care unit.
Measured: 30 days after pronation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start1 Jun 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ARDS, HumanStudies 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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria-Universitaria Integrata di Udine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luigi Vetrugno, Azienda Sanitaria-Universitaria Integrata di Udine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04605133
- Sponsor's protocol ID
- EIT during pronation in ARDS
- Status last verified
- Jul 2021
- First submitted
- 6 Oct 2020
- Last updated
- 21 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.
PubMed 22797452Mauri T, Eronia N, Abbruzzese C, Marcolin R, Coppadoro A, Spadaro S, Patroniti N, Bellani G, Pesenti A. Effects of Sigh on Regional Lung Strain and Ventilation Heterogeneity in Acute Respiratory Failure Patients Undergoing Assisted Mechanical Ventilation. Crit Care Med. 2015 Sep;43(9):1823-31. doi: 10.1097/CCM.0000000000001083.
PubMed 25985386Cinnella G, Grasso S, Raimondo P, D'Antini D, Mirabella L, Rauseo M, Dambrosio M. Physiological Effects of the Open Lung Approach in Patients with Early, Mild, Diffuse Acute Respiratory Distress Syndrome: An Electrical Impedance Tomography Study. Anesthesiology. 2015 Nov;123(5):1113-21. doi: 10.1097/ALN.0000000000000862.
PubMed 26397017Scholten EL, Beitler JR, Prisk GK, Malhotra A. Treatment of ARDS With Prone Positioning. Chest. 2017 Jan;151(1):215-224. doi: 10.1016/j.chest.2016.06.032. Epub 2016 Jul 8.
PubMed 27400909
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Impedance Tomography Monitoring and Invasive Mechanical Ventilation During Pronation in Acute Respiratory Distress Syndrome.
- ClinicalTrials.gov ID
- NCT04605133
- Acronym / sponsor ID
- EIT during pronation in ARDS
- Conditions
- ARDS, Human
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Azienda Sanitaria-Universitaria Integrata di UdineUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 27 Oct 2020 (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.
Acute respiratory distress syndrome is an acute form of lung injury. The most commonly used classification criteria for this syndrome are Berlin's Criteria. The actual literature underlines the advantages of prone position in mild or severe forms of ARDS in association with invasive mechanical ventilation. The hypothesis of this study is to investigate the effective ventilation and perfusion modifications during pronation assessed with clinical parameters and with the aid of the electrical impedance tomography.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARDS | – | Device: Electrical impedance tomographyPatients with mild or severe ARDS necessitating of prone position during mechanical ventilation |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients' anthropometric data were collected. Ventilation parameters, electric impedence tomography parameters and blood gas analysis values were collected four times: patient supine (T0), one hour after pronation (T1), sixteen hours after pronation (T2), one hour after supination (T3).
Key inclusion criteria (2 listed)
- mild or severe ARDS according to Berlin's Criteria
- recruitment maximum 72 hours from the diagnosis of ARDS
Key exclusion criteria (7 listed)
- other non-ARDS respiratory system pathologies
- hemodynamic instability (mean arterial pressure < 60 mmHg)
- pneumothorax
- endocranial hypertension
- skin lesions or burns
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 |
|---|---|---|
| Electrical impedance tomographyEvery patient is monitored with electrical impedance tomograpy before, during and after prone position. | Device | ARDS |
Primary outcome
Pronation and Regions of Interest increase in percentage
Time frame: 1 hour after supination
Demonstrate that pronation, without any recruitment maneuver, augments the dorsal regions of interest of 5%.
4 secondary outcomes
PaO2/FiO2 ratio and ventral/dorsal Regions of Interest ratio
Time frame: 1 hour after supination
Homogeneity of the ventral and dorsal regions from 0 to 1
Time frame: 1 hour after supination
Region of Interest ratio and days of mechanical ventilation.
Time frame: 30 days after pronation
Region of Interest ratio and length of stay in intensive care unit
Time frame: 30 days after pronation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
- Background: PubMed 22797452ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669.
- Background: PubMed 25985386Mauri T, Eronia N, Abbruzzese C, Marcolin R, Coppadoro A, Spadaro S, Patroniti N, Bellani G, Pesenti A. Effects of Sigh on Regional Lung Strain and Ventilation Heterogeneity in Acute Respiratory Failure Patients Undergoing Assisted Mechanical Ventilation. Crit Care Med. 2015 Sep;43(9):1823-31. doi: 10.1097/CCM.0000000000001083.
- Background: PubMed 26397017Cinnella G, Grasso S, Raimondo P, D'Antini D, Mirabella L, Rauseo M, Dambrosio M. Physiological Effects of the Open Lung Approach in Patients with Early, Mild, Diffuse Acute Respiratory Distress Syndrome: An Electrical Impedance Tomography Study. Anesthesiology. 2015 Nov;123(5):1113-21. doi: 10.1097/ALN.0000000000000862.
- Background: PubMed 27400909Scholten EL, Beitler JR, Prisk GK, Malhotra A. Treatment of ARDS With Prone Positioning. Chest. 2017 Jan;151(1):215-224. doi: 10.1016/j.chest.2016.06.032. Epub 2016 Jul 8.
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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?
An observational study of ARDS, Human, run by Azienda Sanitaria-Universitaria Integrata di Udine 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 7 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: status not confirmed, as of the sponsor's last update on 21 Jul 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?
Results are not available in the source record.
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?
Pronation and Regions of Interest increase in percentage (time frame: 1 hour after supination). 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 NCT04605133, which also lists 4 linked publications.
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 21 Jul 2021.