Prone PositionPronEITNCT06184490
Prone Position With Different Types of Cushions in Patients With ARDS
A study testing Prone position with thoraco-abdominal cushion in people with Prone Position and Acute Respiratory Distress Syndrome, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
The prone maneuver is a well-established therapy in ARDS. Traditionally, the maneuver is perform with thoraco-abdominal cushions. The goal of this study is assess, using electrical impedance tomography, whether the arrangement mode of the cushions alters lung recruitment during the prone maneuver in patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prone Position, Acute Respiratory Distress Syndrome
- What is being tested?
- Prone position with thoraco-abdominal cushion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Aug 2023to Dec 2025
- 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
- Adult patients aged 18 years or more, with
- moderate or severe acute respiratory distress syndrome (ARDS), and
- indication of prone position
Who cannot join
- Contra-indication to the prone position: intracranial pressure > 30 mmHg or cerebral perfusion pressure < 60 mmHg; massive haemoptysis needing urgent surgical or radiological treatment; tracheal or thoracic surgery in the last 15 days; facial trauma or surgery in the last 15 days; deep venous thrombosis or pulmonary embolism treated in the last 2 days; unstable bone dislocations of rachis, femur, rib cage, pelvis; mean systolic arterial pressure less than 70 mmHg despite vasopressive therapy and pregnancy
- Severe acute respiratory distress syndrome (ARDS) caused b coronavirus disease 2019 (despite meeting the Berlin criteria for ARDS, their ventilatory mechanics are characterized by nearly normal compliance, something rarely seen in patients with ARDS from other etiologies)
- contraindications for the use of Electrical Impedance Tomography (EIT) such as presence of a cardiac implantable electronic device
- Pulmonary transplantation
- Prone position before enrollment
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035903
Vanessa Martins de Oliveira, +55519992513723, vmoliveira@hcpa.edu.br
About this study
Official title: Prone Position With Different Types of Cushions in Patients With Acute Respiratory Distress Syndrome - Effects on Mechanics, Oxygenation, and Electrical Impedance Tomography Imaging
The prone maneuver is a well-established therapy in ARDS. Traditionally, the maneuver is perform with thoraco-abdominal cushions. The goal of this study is assess, using electrical impedance tomography, whether the arrangement mode of the cushions alters lung recruitment during the prone maneuver in patients with moderate to severe ARDS.
Read the detailed description
The prone position is a ventilatory therapeutic strategy used in the treatment of patients with moderate to severe Acute Respiratory Distress Syndrome (ARDS) that promotes improved oxygenation with consequent reduction in mortality. Despite being safe and effective, it is not without complications, with pressure injuries being one of the main concerns. The use of cushions helps prevent such injuries, but they can interfere with ventilatory mechanics depending on where they are placed. The aim of this study is to assess whether there is a difference in ventilatory mechanics when performing the prone maneuver with a thoraco-abdominal cushion or a modified lateral cushion, based on measurements from electrical impedance tomography (EIT), gasometric data, and parameters of mechanical ventilation.
- Being tested
- Prone position with thoraco-abdominal cushion
- 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 with thoraco-abdominal cushionProcedure or surgery
Prone position with cushions positioned laterally on the chest, abdomen, and pelvis
| Study group | Role | What they receive |
|---|---|---|
| Usual prone position | No intervention | Prone position with thoraco-abdominal support (cushions on the chest and hips, leaving the abdomen free) |
| Modified prone position | Experimental | Prone position with lateral support (lateral cushions on the chest, hips and abdomen) Receives: Procedure: Prone position with thoraco-abdominal cushion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung recruitment
Change in ventilation of dorsal regions of lung (%) assessed by electrical impedance tomography
Measured: 1 hour before prone - 2 hours before supine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2023
- Study start15 Aug 2023
- Primary completionAug 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prone PositionStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vanessa Martins de de Oliveira, Principal investigator, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06184490
- Sponsor's protocol ID
- 2022-0323
- Acronym
- PronEIT
- Status last verified
- Dec 2023
- First submitted
- 14 Dec 2023
- Last updated
- 28 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prone Position With Different Types of Cushions in Patients With Acute Respiratory Distress Syndrome - Effects on Mechanics, Oxygenation, and Electrical Impedance Tomography Imaging
- ClinicalTrials.gov ID
- NCT06184490
- Acronym / sponsor ID
- PronEIT / 2022-0323
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 28 Dec 2023 (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 prone maneuver is a well-established therapy in ARDS. Traditionally, the maneuver is perform with thoraco-abdominal cushions. The goal of this study is assess, using electrical impedance tomography, whether the arrangement mode of the cushions alters lung recruitment during the prone maneuver in patients with moderate to severe ARDS.
Detailed description
The prone position is a ventilatory therapeutic strategy used in the treatment of patients with moderate to severe Acute Respiratory Distress Syndrome (ARDS) that promotes improved oxygenation with consequent reduction in mortality. Despite being safe and effective, it is not without complications, with pressure injuries being one of the main concerns. The use of cushions helps prevent such injuries, but they can interfere with ventilatory mechanics depending on where they are placed. The aim of this study is to assess whether there is a difference in ventilatory mechanics when performing the prone maneuver with a thoraco-abdominal cushion or a modified lateral cushion, based on measurements from electrical impedance tomography (EIT), gasometric data, and parameters of mechanical ventilation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual prone position | No intervention | –Prone position with thoraco-abdominal support (cushions on the chest and hips, leaving the abdomen free) |
| Modified prone position | Experimental | Procedure: Prone position with thoraco-abdominal cushionProne position with lateral support (lateral cushions on the chest, hips and abdomen) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients aged 18 years or more, with
- moderate or severe acute respiratory distress syndrome (ARDS), and
- indication of prone position
Key exclusion criteria (5 listed)
- Contra-indication to the prone position: intracranial pressure > 30 mmHg or cerebral perfusion pressure < 60 mmHg; massive haemoptysis needing urgent surgical or radiological treatment; tracheal or thoracic surgery in the last 15 days; facial trauma or surgery in the last 15 days; deep venous thrombosis or pulmonary embolism treated in the last 2 days; unstable bone dislocations of rachis, femur, rib cage, pelvis; mean systolic arterial pressure less than 70 mmHg despite vasopressive therapy and pregnancy
- Severe acute respiratory distress syndrome (ARDS) caused b coronavirus disease 2019 (despite meeting the Berlin criteria for ARDS, their ventilatory mechanics are characterized by nearly normal compliance, something rarely seen in patients with ARDS from other etiologies)
- contraindications for the use of Electrical Impedance Tomography (EIT) such as presence of a cardiac implantable electronic device
- Pulmonary transplantation
- Prone position before enrollment
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 with thoraco-abdominal cushionProne position with cushions positioned laterally on the chest, abdomen, and pelvis | Procedure or surgery | Modified prone position |
Primary outcome
Lung recruitment
Time frame: 1 hour before prone - 2 hours before supine
Change in ventilation of dorsal regions of lung (%) assessed by electrical impedance tomography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Vanessa Martins de de Oliveira principal investigator
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prone position with thoraco-abdominal cushion in people with Prone Position and Acute Respiratory Distress Syndrome, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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: status not confirmed, as of the sponsor's last update on 28 Dec 2023. 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 Brazil. 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 Vanessa Martins de de Oliveira (+55519992513723, vmoliveira@hcpa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung recruitment (time frame: 1 hour before prone - 2 hours before supine). 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 28 Dec 2023.