ARDSNCT05408442
Role of Pulmonary Perfusion on Tolerance to Supine Position in Patients With ARDS
An observational study of ARDS and Mechanical Ventilation, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial summary
The relationship between the presence or absence of endothelial dysfunction and changes in pulmonary perfusion will be evaluated, to then determine if there is any association between changes in the V / Q ratio and tolerance to the supine position after a prone cycle in patients with acute respiratory distress… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS, Mechanical Ventilation, Prone Position
- How many people
- 20 participants
- Where
- 1 siteChile
- Study dates
- 1 Jul 2021to 31 Dec 2022
- How long will I take part?
- 2 Months
- 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: Patients admitted in the ICU of Hospital Clínico Universidad Católica
Who may be able to join
- Patients with a diagnosis of ARDS
- Patients connected to IMV
- Patients in prone position for less than 48 hours.
Who cannot join
- Diagnosis of exacerbation of chronic lung disease or cardiogenic pulmonary edema.
- Presence of contraindications for the use of the prone position and for the use of the EIT belt
- Patient under 18 years of age
- Pregnancy
- Refusal of informed consent.
Trial locations and contacts
1 site in 1 country.
Chile1 site
Hospital Clínico Universidad Católica
Santiago, Santiago Metropolitan, Santiago
About this study
Official title: Role of Pulmonary Perfusion on Tolerance to Supine Position in Patients With Acute Respiratory Distress Syndrome on Mechanical Ventilation
The relationship between the presence or absence of endothelial dysfunction and changes in pulmonary perfusion will be evaluated, to then determine if there is any association between changes in the V / Q ratio and tolerance to the supine position after a prone cycle in patients with acute respiratory distress syndrome on mechanical ventilation.
Read the detailed description
The prone position is a strategy used in patients with respiratory failure in order to improve oxygenation, it has proven to be very effective compared to the supine position, reducing mortality in critically ill patients diagnosed with acute respiratory distress syndrome. Physiologically, these clinical findings could be explained by an improvement in the ventilation/perfusion ratio (V/Q). Animal studies have shown that the prone position significantly decreases the collapse of the dorsal regions of the lung, the one that anatomically receives the highest percentage of blood flow. Nevertheless, to this day the physiology behind these benefits in critically ill patients has not been studied, and without this, the indications for use or duration of the maneuver has not yet been determined.
For many intensivists, determining the best time to re-supinate the patient is one of the greatest challenges they face in clinical practice, since intolerance to supine position and the need for a new prone cycle has been associated to the risk of complications, such as accidental extubation, hemodynamic instability and intensive care unit (ICU) acquired weakness. For this reason, it is relevant to determine what factors are associated with tolerance to supine position, and knowing the presence of vascular defects due to endothelial dysfunction during conventional and COVID-19 ARDS, our hypothesis is that patients who do not tolerate the change to supine position after a prone cycle are unable to maintain an optimal V/Q ratio, this due to the loss of regulation of the hypoxic pulmonary vasoconstriction phenomenon related to endothelial dysfunction markers.
For this observational cohort clinical study, patients admitted to the intensive care unit of the UC-CHRISTUS Clinical Hospital with diagnosis of ARDS will be evaluated. After inclusion and the signing of the informed consent, physiological data of the patients will be recorded. In addition, an evaluation of vascular function will be performed through ultrasound, near infrared spectroscopy, and markers of endothelial damage in plasma. After baseline measurements, the distribution of pulmonary ventilation and perfusion through EIT, pulmonary function, hemodynamic, ventilatory and arterial gases will be evaluated. These measurements will be taken again 1 hour before to position change, and 1, 8, 12 and 24 hours after the change to supine position.
With this study the investigators hope to be able to find a pattern associated to endothelial function and perfusion in these patients that allows us to determine which patient can be repositioned supine, without the need for a new prone cycle. With this information, an evaluation and management protocol could be developed at long term for patients subjected to prone position, which allows less time in mechanical ventilation and a reduction of the complications and risks associated with the maneuver and with the ICU length of stay that directly affects the quality of life of these patients in the short and long term.
- Conditions
- ARDS, Mechanical Ventilation, Prone Position
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Prone | ARDS patients during mechanical ventilation in prone position Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerance to supine position
It will be defined by changes in PaO2/FiO2 after position changes
Measured: 12 hours
Secondary outcomes (5)
Endothelial dysfunction
Presence of endothelial dysfunction markers in plasma (angiopoietin-1)
Measured: 48 hours
V/Q changes
Changes in ventilation/perfusion ratio
Measured: 48 hours
Endothelial dysfunction
Presence of P-selectin in plasma
Measured: 48 hours
Endothelial dysfunction
Presence of E-selectin in plasma
Measured: 48 hours
Endothelial dysfunction
Presence of VCAM-1 in plasma
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2022
- Study start1 Jul 2021
- Primary completion1 Jun 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDSStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- 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
- 20 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Consuelo Bachmann, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05408442
- Sponsor's protocol ID
- 210309002
- Status last verified
- Aug 2024
- First submitted
- 1 Jun 2022
- Last updated
- 7 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Pulmonary Perfusion on Tolerance to Supine Position in Patients With Acute Respiratory Distress Syndrome on Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT05408442
- Acronym / sponsor ID
- 210309002
- Conditions
- ARDS, Mechanical Ventilation, Prone Position
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 7 Jun 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 relationship between the presence or absence of endothelial dysfunction and changes in pulmonary perfusion will be evaluated, to then determine if there is any association between changes in the V / Q ratio and tolerance to the supine position after a prone cycle in patients with acute respiratory distress syndrome on mechanical ventilation.
Detailed description
The prone position is a strategy used in patients with respiratory failure in order to improve oxygenation, it has proven to be very effective compared to the supine position, reducing mortality in critically ill patients diagnosed with acute respiratory distress syndrome. Physiologically, these clinical findings could be explained by an improvement in the ventilation/perfusion ratio (V/Q). Animal studies have shown that the prone position significantly decreases the collapse of the dorsal regions of the lung, the one that anatomically receives the highest percentage of blood flow. Nevertheless, to this day the physiology behind these benefits in critically ill patients has not been studied, and without this, the indications for use or duration of the maneuver has not yet been determined.
For many intensivists, determining the best time to re-supinate the patient is one of the greatest challenges they face in clinical practice, since intolerance to supine position and the need for a new prone cycle has been associated to the risk of complications, such as accidental extubation, hemodynamic instability and intensive care unit (ICU) acquired weakness. For this reason, it is relevant to determine what factors are associated with tolerance to supine position, and knowing the presence of vascular defects due to endothelial dysfunction during conventional and COVID-19 ARDS, our hypothesis is that patients who do not tolerate the change to supine position after a prone cycle are unable to maintain an optimal V/Q ratio, this due to the loss of regulation of the hypoxic pulmonary vasoconstriction phenomenon related to endothelial dysfunction markers.
For this observational cohort clinical study, patients admitted to the intensive care unit of the UC-CHRISTUS Clinical Hospital with diagnosis of ARDS will be evaluated. After inclusion and the signing of the informed consent, physiological data of the patients will be recorded. In addition, an evaluation of vascular function will be performed through ultrasound, near infrared spectroscopy, and markers of endothelial damage in plasma. After baseline measurements, the distribution of pulmonary ventilation and perfusion through EIT, pulmonary function, hemodynamic, ventilatory and arterial gases will be evaluated. These measurements will be taken again 1 hour before to position change, and 1, 8, 12 and 24 hours after the change to supine position.
With this study the investigators hope to be able to find a pattern associated to endothelial function and perfusion in these patients that allows us to determine which patient can be repositioned supine, without the need for a new prone cycle. With this information, an evaluation and management protocol could be developed at long term for patients subjected to prone position, which allows less time in mechanical ventilation and a reduction of the complications and risks associated with the maneuver and with the ICU length of stay that directly affects the quality of life of these patients in the short and long term.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prone | – | Other: No interventionARDS patients during mechanical ventilation in prone position |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted in the ICU of Hospital Clínico Universidad Católica
Key inclusion criteria (3 listed)
- Patients with a diagnosis of ARDS
- Patients connected to IMV
- Patients in prone position for less than 48 hours.
Key exclusion criteria (5 listed)
- Diagnosis of exacerbation of chronic lung disease or cardiogenic pulmonary edema.
- Presence of contraindications for the use of the prone position and for the use of the EIT belt
- Patient under 18 years of age
- Pregnancy
- Refusal of informed consent.
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 |
|---|---|---|
| No interventionNo intervention | Other | Prone |
Primary outcome
Tolerance to supine position
Time frame: 12 hours
It will be defined by changes in PaO2/FiO2 after position changes
5 secondary outcomes
Endothelial dysfunction
Time frame: 48 hours
V/Q changes
Time frame: 48 hours
Endothelial dysfunction
Time frame: 48 hours
Endothelial dysfunction
Time frame: 48 hours
Endothelial dysfunction
Time frame: 48 hours
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 7 Aug 2024.
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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 and Mechanical Ventilation, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
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 3 inclusion and 5 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 7 Aug 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 Chile. 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?
Tolerance to supine position (time frame: 12 hours). 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 7 Aug 2024.