Acute Respiratory Distress SyndromeNCT05198986
Pronation During Veno-venous Extra Corporeal Membrane Oxygenation
An observational study of Acute Respiratory Distress Syndrome and Acute Respiratory Failure, run by University Magna Graecia at 1 site in Italy.
Trial summary
The Acute Respiratory Distress Syndrome (ARDS) is defined by a recent (within 1 week) respiratory failure, not fully explained by cardiac failure or fluid overload. ARDS is also characterized by bilateral opacities at the chest imaging, with an alteration of the oxygenation while positive end-expiratory pressure equal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Acute Respiratory Failure
- What is being tested?
- Prone Position during Extra Corporeal Membrane Oxygenation (ECMO)
- How many people
- 15 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2022to 28 Feb 2023
- 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: All patients will receive deep sedation and continuous infusion of neuromuscular blocking agents. Protective mechanical ventilation will be set in volume-controlled mode. A pulmonary artery catheter (PAC) will be also positioned and connected to a dedicated system for hemodynamic monitoring. After enrolment, a silicon 16-electrode belt of proper size will be positioned around the patient's chest between the 4th and 6th intercostal spaces and connected to the EIT device. The position of EIT belt will be therefore marked on the skin with a dermographic pencil to avoid its displacement. Invasive mechanical ventilation will be applied with a ventilator connected to the EIT device through a RS232 interface.
Who may be able to join
- all adult patients with a diagnosis of severe Acute Respiratory Distress Syndrome receiving veno-venous ECMO
- refusal of consent.
Who cannot join
- mechanical ventilation for 7 days or longer
- pregnancy
- body mass index (BMI) > 45 kg/m2
- chronic respiratory failure with long-term oxygen therapy or domiciliary non-invasive ventilation
- cardiac failure resulting in veno-arterial ECMO
- history of heparin- induced thrombocytopenia
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- cancer with a life expectancy of less than 5 years
- moribund condition or a Simplified Acute Physiology Score (SAPS-II) value of more than 90;
- current non drug- induced coma after cardiac arrest or presence of an irreversible neurologic injury
- decision to withhold or withdraw life--sustaining therapies
- presence of pneumothorax and/or pulmonary emphysema
- recent (1 week) thoracic surgery
- presence of chest burns
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Pronation on Respiratory System Mechanical Properties and Ventilation in Patients With Acute Respiratory Distress Syndrome During Vv-ecmo
The Acute Respiratory Distress Syndrome (ARDS) is defined by a recent (within 1 week) respiratory failure, not fully explained by cardiac failure or fluid overload. ARDS is also characterized by bilateral opacities at the chest imaging, with an alteration of the oxygenation while positive end-expiratory pressure equal or greater than 5 cmH2O is applied. Severe ARDS is characterized by a high mortality. In the most severe ARDS patients, venovenous extracorporeal membrane oxygenation (vv-ECMO) is increasingly accepted as a mean to support vital function, although not free from complications.
In patients with severe ARDS, prone position has been used for many years to improve oxygenation. In these patients, early application of prolonged (16 hours) prone-positioning sessions significantly decreased 28-day and 90-day mortality. More recently, prone position and ECMO have been coupled as concurrent treatment. Indeed, the addition of prone positioning therapy concurrently with ECMO can aid in optimizing alveolar recruitment, and reducing ventilator-induced lung injury. Nowadays, few data exist on respiratory mechanics modifications before and after the application of prone position in patients with severe ARDS receiving vv-ECMO. The investigators have therefore designed this observational study to assess the modifications of mechanical properties of the respiratory system, ventilation and aeration distribution, and hemodynamics occurring during ECMO before and after prone position in patients with severe ARDS.
- Being tested
- Prone Position during Extra Corporeal Membrane Oxygenation (ECMO)
- Keywords
- Extra Corporeal Membrane Oxygenation, Prone Position
- 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.
Prone Position during Extra Corporeal Membrane Oxygenation (ECMO)Other
Pronation will be executed according to a predefined protocol: 4 caregivers will be required for the procedure, one of them being dedicated to the management of the head of the patient, the endotracheal tube and the ventilator lines. The others will stand at each side of the bed. In the first step, the direction of the rotation will be decided giving priority to the side of the central venous lines. The patient will be then moved along the horizontal plane to the opposite side of the bed selected for the direction of rotation. In the third step, the patient will be moved in the sagittal plane and maintained in that position for a short while to attach the cardiac electrodes to her/his back and to set a new bed sheet. In the last step, the patient will be turned to the complete prone position.
| Study group | Role | What they receive |
|---|---|---|
| ECMO Prone Position | After baseline assessment in supine position, patients will be positioned in prone position to assess modification of lung mechanics, aeration and hemodynamics Receives: Other: Prone Position during Extra Corporeal Membrane Oxygenation (ECMO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Driving Pressure
Difference between the airway plateau pressure and the total positive end-expiratory pressure after an inspiratory and expiratory hold maneuvers, respectively
Measured: 30 minutes after the prone positioning
Secondary outcomes (4)
Respiratory system compliance
Driving pressure to the tidal volume ratio
Measured: 30 minutes after the prone positioning
Cardiac output
Liters of blood flow ejected from the heart per minute, measured through a pulmonary artery catheter
Measured: 30 minutes after the prone positioning
Pulmonary arterial pressure
pulmonary arterial pressure measured through a pulmonary artery catheter
Measured: 30 minutes after the prone positioning
End-Expiratory Lung Impedance
Measurement of the end expiratory lung volume, as assessed by the electrical impedance tomography
Measured: 30 minutes after the prone positioning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start1 Feb 2022 (estimated)
- Primary completion28 Feb 2023 (estimated)
- Study completion28 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Magna Graecia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Federico Longhini, University Magna Graecia
- Investigators
- Federico Longhini, MD, Principal investigator, Magna graecia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05198986
- Sponsor's protocol ID
- ECMO-PP
- Status last verified
- Jan 2022
- First submitted
- 3 Jan 2022
- Last updated
- 20 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deindividualized data will be share on reasonable request to the Principal Investigator after study completion and publication
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pronation on Respiratory System Mechanical Properties and Ventilation in Patients With Acute Respiratory Distress Syndrome During Vv-ecmo
- ClinicalTrials.gov ID
- NCT05198986
- Acronym / sponsor ID
- ECMO-PP
- Keywords
- Extra Corporeal Membrane Oxygenation, Prone Position
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Magna GraeciaUniversity, hospital or other
- Study start
- 1 Feb 2022 (estimated)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 20 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.
The Acute Respiratory Distress Syndrome (ARDS) is defined by a recent (within 1 week) respiratory failure, not fully explained by cardiac failure or fluid overload. ARDS is also characterized by bilateral opacities at the chest imaging, with an alteration of the oxygenation while positive end-expiratory pressure equal or greater than 5 cmH2O is applied. Severe ARDS is characterized by a high mortality. In the most severe ARDS patients, venovenous extracorporeal membrane oxygenation (vv-ECMO) is increasingly accepted as a mean to support vital function, although not free from complications.
In patients with severe ARDS, prone position has been used for many years to improve oxygenation. In these patients, early application of prolonged (16 hours) prone-positioning sessions significantly decreased 28-day and 90-day mortality. More recently, prone position and ECMO have been coupled as concurrent treatment. Indeed, the addition of prone positioning therapy concurrently with ECMO can aid in optimizing alveolar recruitment, and reducing ventilator-induced lung injury. Nowadays, few data exist on respiratory mechanics modifications before and after the application of prone position in patients with severe ARDS receiving vv-ECMO. The investigators have therefore designed this observational study to assess the modifications of mechanical properties of the respiratory system, ventilation and aeration distribution, and hemodynamics occurring during ECMO before and after prone position in patients with severe ARDS.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ECMO Prone Position | – | Other: Prone Position during Extra Corporeal Membrane Oxygenation (ECMO)After baseline assessment in supine position, patients will be positioned in prone position to assess modification of lung mechanics, aeration and hemodynamics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients will receive deep sedation and continuous infusion of neuromuscular blocking agents. Protective mechanical ventilation will be set in volume-controlled mode. A pulmonary artery catheter (PAC) will be also positioned and connected to a dedicated system for hemodynamic monitoring. After enrolment, a silicon 16-electrode belt of proper size will be positioned around the patient's chest between the 4th and 6th intercostal spaces and connected to the EIT device. The position of EIT belt will be therefore marked on the skin with a dermographic pencil to avoid its displacement. Invasive mechanical ventilation will be applied with a ventilator connected to the EIT device through a RS232 interface.
Key inclusion criteria (2 listed)
- all adult patients with a diagnosis of severe Acute Respiratory Distress Syndrome receiving veno-venous ECMO
- refusal of consent.
Key exclusion criteria (13 listed)
- mechanical ventilation for 7 days or longer
- pregnancy
- body mass index (BMI) > 45 kg/m2
- chronic respiratory failure with long-term oxygen therapy or domiciliary non-invasive ventilation
- cardiac failure resulting in veno-arterial ECMO
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 Position during Extra Corporeal Membrane Oxygenation (ECMO)Pronation will be executed according to a predefined protocol: 4 caregivers will be required for the procedure, one of them being dedicated to the management of the head of the patient, the endotracheal tube and the ventilator lines. The others will stand at each side of the bed. In the first step, the direction of the rotation will be decided giving priority to the side of the central venous lines. The patient will be then moved along the horizontal plane to the opposite side of the bed selected for the direction of rotation. In the third step, the patient will be moved in the sagittal plane and maintained in that position for a short while to attach the cardiac electrodes to her/his back and to set a new bed sheet. In the last step, the patient will be turned to the complete prone position. | Other | ECMO Prone Position |
Primary outcome
Driving Pressure
Time frame: 30 minutes after the prone positioning
Difference between the airway plateau pressure and the total positive end-expiratory pressure after an inspiratory and expiratory hold maneuvers, respectively
4 secondary outcomes
Respiratory system compliance
Time frame: 30 minutes after the prone positioning
Cardiac output
Time frame: 30 minutes after the prone positioning
Pulmonary arterial pressure
Time frame: 30 minutes after the prone positioning
End-Expiratory Lung Impedance
Time frame: 30 minutes after the prone positioning
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2022.
- Individual participant dataSharing planned: Yes. Deindividualized data will be share on reasonable request to the Principal Investigator after study completion and publication
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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.
Federico Longhini, MD principal investigator
Magna graecia University
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 Acute Respiratory Distress Syndrome and Acute Respiratory Failure, run by University Magna Graecia 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 13 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 20 Jan 2022. 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?
Contact Federico Longhini, MD (+393475395967, longhini.federico@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Driving Pressure (time frame: 30 minutes after the prone positioning). 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 20 Jan 2022.