ARDSLAT&PRONENCT06647784
Lateral Positioning and Prone Positioning in ARDS Patients
A study testing pulmonary aeration in supine and ventral decubitus in people with ARDS, run by Centre Hospitalier de Bastia at 2 sites in France.
Trial summary
Lateral (30°) and alternating positioning (change of side every 30 minutes) carried out on specific beds, could be an alternative or complement to prone positioning (PP) in ARDS patients. The combination of lateralization in prone position has not been studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS
- What is being tested?
- pulmonary aeration in supine and ventral decubitus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesFrance
- Study dates
- 26 Nov 2024to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age of at least 18 years
- ARDS evolving for less than 5 days with a PaO2/FiO2 ratio (P/F ratio) < 150 after optimization of PEEP (P/V curve, R/I ratio), curarization and without prior use of the PP since orotracheal intubation.
- Obtained written consent of the patient, one of his relatives or the previously designated trusted person. As soon as possible, the patient will be informed and his written consent will be obtained
- Beneficiary of health insurance coverage
- Possibility of participating in any other studies whose evaluation criteria do not interfere with those of the study
- Non-inclusion criteria:
Show all 23Show fewer
- Patients with at least one of the following criteria will not be eligible:
- Refusal to participate
- Pregnant, parturient or breastfeeding women
- Intracranial pressure > 30 mm Hg or cerebral perfusion pressure < 60 mmHg
- Severe chronic respiratory disease with oxygen therapy or mechanical ventilation at home (except CPAP/BIPAP for obstructive sleep apnea)
- Chronic interstitial lung diseases
- Patients on ECMO
- Weight > 100 kg
- Severe liver disease Child-Pugh score 12-15
- Pneumothorax
- SAPS II score > 75 at inclusion
- Unstable spinal fracture
- Contraindications to EIT (pacemaker, implantable defibrillator, skin lesions between the 4th and 5th ribs).
- Withdrawal (except for ECMO) or witholding treatment decision
- Any other reason which, according to the investigator, could interfere with the evaluation of the study objectives
- Person under legal protection measure (guardianship, curatorship, etc.)
- Person deprived of liberty by a judiciary or administrative decision
Who cannot join
- Patients who will be unable to complete the 25-hour intervention due to worsening requiring ECMO, death or organizational problems will be excluded from the analysis.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Bastia General Hospital
Bastia, France, 20604
Laurent Papazian, MD,PHD, 0495591039, laurent.papazian@ch-bastia.fr
Antoine Faure, HP, 0495591111, antoine.faure@ch-bastia.fr
- Recruiting
North Hospital Marseille
Marseille, France, 13915
Sami Hraiech, MD,PHD, 0491964358, sami.hraiech@ap-hm.fr
Antoine Roch, MD,PHD, 0491965835, antoine.roch@ap-hm.fr
About this study
Official title: Effect of Lateralization Before and During Prone Position on Pulmonary Aeration During ARDS
Lateral (30°) and alternating positioning (change of side every 30 minutes) carried out on specific beds, could be an alternative or complement to prone positioning (PP) in ARDS patients. The combination of lateralization in prone position has not been studied. The dynamic created by lateralization could allow better overall ventilation during PP, thus making it possible to further improve oxygenation. The main objective of this prospective, bicentric, open, single group study with repeated measures will be to demonstrate that the addition of repeated 30-minute periods of 30° lateralization improves pulmonary aeration in the supine and prone positions in patients with moderate to severe ARDS.
Read the detailed description
Primary objective: assessment of the distribution of tidal volume after lateralization and according to the position (supine position SP, prone position, PP) by measuring global and regional changes (4 regions of interest from the retrosternal region to the prevertebral region) of pulmonary aeration assessed by electrical impedance tomography (EIT). The primary endpoint will be the change in pulmonary aeration after lateralization in SP (T2) and in PP (T5) estimated by the change in end-expiratory lung impedance (EELI) = [ΔEELI x (VT/ΔZ)] where VT is the tidal volume and ΔZ is the impedance change.
Main secondary objective: assessment of perfusion and gas exchange after each period of lateralization compared to the baseline period in supine position (baseline SP) and in ventral position (baseline PP) (endpoints: PaO2/FiO2 and PaCO2)
Other secondary objectives:
- Evaluation of the percentage of patients who, at the end of the period of lateralization in supine position (T2), have a PaO2/FiO2 ratio > 150
- Comparisons baseline SP with baseline PP, PP 6 hours, PP and lateral positioning (LP) 12 hours and return to supine position since 1 hour (End) for pulmonary aeration, gas exchange and ventilatory parameters (endpoints: PaO2/FiO2 and PaCO2, (EELI) = [ΔEELI x (VT/ΔZ)], plateau pressure, driving pressure).
- Baseline PP comparisons with PP 6 hours, PP and lateral positioning (LP) 12 hours and return to supine position since 1 hour (End) for pulmonary aeration, gas exchange and ventilatory parameters (endpoints: PaO2/FiO2 and PaCO2, (EELI) = [ΔEELI x (VT/ΔZ)], plateau pressure, driving pressure)
- LP comparisons in SP for 6 hours with LP in PP for 12 hours for pulmonary aeration, gas exchange and ventilatory parameters (endpoints: PaO2/FiO2 and PaCO2, (EELI) = [ΔEELI x (VT/ΔZ)], plateau pressure, driving pressure)
- LP comparisons in PP for 12 hours with return to supine position since 1 hour (End) for pulmonary aeration, gas exchange and ventilatory parameters (endpoints: PaO2/FiO2 and PaCO2, (EELI) = [ΔEELI x (VT/ΔZ)], plateau pressure, driving pressure) : PaO2/FiO2 and PaCO2, (EELI) = [ΔEELI x (VT/ΔZ)], plateau pressure, driving pressure)
- Evaluate the adverse effects related to the use of lateral positioning.
- Conditions
- ARDS
- Being tested
- pulmonary aeration in supine and ventral decubitus
- Keywords
- ARDS, Pulmonary aeration, Supine, prone position, lateralization
- Medical subject headings
- Deception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulmonary aeration in supine and ventral decubitusOther
The addition of repeated periods of 30 minutes of lateralization of 30° amplitude in dorsal decubitus and in ventral decubitus in patients with moderate to severe ARDS. Included patients will benefit from sessions of lateral decubitus for 30 minutes on each side (with an inclination of 30°) with alternation right/left (total one hour). During this period, the upper part of the bed will be inclined by 30°. Patients will then be positioned in strict prone position for a period of 6 hours after which, the same pattern of alternating lateral decubitus will be applied for 12 hours while the patient is still in the prone position. After reversal in supine position, an observation period of 1 hour will be respected before carrying out the last measurements. The total duration of the intervention will be 20 hours.
| Study group | Role | What they receive |
|---|---|---|
| Lateral and alterning positioning | Experimental | Baseline assessment in SP followed by repeated 30-minute lateral decubitus sessions on each side (with a 30° inclination) with a right/left alternation (total duration, 1 hour). During this period, the upper part of the bed will be inclined by 30°. The patients will then be positioned in prone position for a period of 6 hours after which, the same alternating lateral decubitus pattern (repeated 30-minute lateral decubitus sessions on each side with a right/left alternation ) will be applied for 12 hours while the patient is still in prone position. After turning back to the supine position, a 1-hour observation period will be respected before the last measurements are taken. The total duration of the intervention will thus be 20 hours. Receives: Other: pulmonary aeration in supine and ventral decubitus |
What is being measured
The primary outcome is the main question the study is designed to answer.
modification of pulmonary aeration
Evaluation of the distribution of tidal volume after lateralization and according to the position (supine: SP, prone: PP) by measuring global changes and regional (4 regions of interest from the retro-sternal region to the pre-vertebral region) of ventilation lung assessed by electrical impedance tomography (EIT).The primary endpoint will be the change in pulmonary aeration after lateralization in SP (T2) and in PP (T5) estimated by the variation in end-expiration pulmonary impedance (EELI) = [ΔEELI x (VT/ΔZ)] where VT is the tidal volume and ΔZ the impedance variation.
Measured: Up to 25 hours.
Secondary outcomes (2)
Assessment of gas exchange
Assessment of gas exchange (by blood gas analyses) after each each lateralization period compared with the baseline period in dorsal position (SP) and prone position (baseline PP) (endpoints: PaO2/FiO2 and PaCO2)
Measured: Up to 25 hours
Assessment of lung perfusion
Assessment of lung perfusion by EIT (administration of 10 ml 7.5% hypertonic saline during an expiratory pause)
Measured: Up to 25 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start26 Nov 2024
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
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.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Lateralization using a commercialy available bed (Multicare X LINET)
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Bastia
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
- Responsible party
- Sponsor
- Investigators
- laurent papazian, MD,PHD, Study director, Bastia General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06647784
- Sponsor's protocol ID
- LATPRON-24-01
- Other IDs
- ID-RCB 2024-A01321-46
- Acronym
- LAT&PRONE
- Status last verified
- May 2025
- First submitted
- 16 Oct 2024
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only IPD used in the results publication
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lateralization Before and During Prone Position on Pulmonary Aeration During ARDS
- ClinicalTrials.gov ID
- NCT06647784
- Acronym / sponsor ID
- LAT&PRONE / LATPRON-24-01
- Conditions
- ARDS
- Keywords
- ARDS, Pulmonary aeration, Supine, prone position, lateralization
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre Hospitalier de BastiaUniversity, hospital or other
- Collaborators
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
- Study start
- 26 Nov 2024 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 18 Oct 2024 (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.
Lateral (30°) and alternating positioning (change of side every 30 minutes) carried out on specific beds, could be an alternative or complement to prone positioning (PP) in ARDS patients. The combination of lateralization in prone position has not been studied. The dynamic created by lateralization could allow better overall ventilation during PP, thus making it possible to further improve oxygenation. The main objective of this prospective, bicentric, open, single group study with repeated measures will be to demonstrate that the addition of repeated 30-minute periods of 30° lateralization improves pulmonary aeration in the supine and prone positions in patients with moderate to severe ARDS.
Detailed description
Primary objective: assessment of the distribution of tidal volume after lateralization and according to the position (supine position SP, prone position, PP) by measuring global and regional changes (4 regions of interest from the retrosternal region to the prevertebral region) of pulmonary aeration assessed by electrical impedance tomography (EIT). The primary endpoint will be the change in pulmonary aeration after lateralization in SP (T2) and in PP (T5) estimated by the change in end-expiratory lung impedance (EELI) = [ΔEELI x (VT/ΔZ)] where VT is the tidal volume and ΔZ is the impedance change.
Main secondary objective: assessment of perfusion and gas exchange after each period of lateralization compared to the baseline period in supine position (baseline SP) and in ventral position (baseline PP) (endpoints: PaO2/FiO2 and PaCO2)
Other secondary objectives:
- Evaluation of the percentage of patients who, at the end of the period of lateralization in supine position (T2), have a PaO2/FiO2 ratio > 150
- Comparisons baseline SP with baseline PP, PP 6 hours, PP and lateral positioning (LP) 12 hours and return to supine position since 1 hour (End) for pulmonary aeration, gas exchange and ventilatory parameters (endpoints: PaO2/FiO2 and PaCO2, (EELI) = [ΔEELI x (VT/ΔZ)], plateau pressure, driving pressure).
- Baseline PP comparisons with PP 6 hours, PP and lateral positioning (LP) 12 hours and return to supine position since 1 hour (End) for pulmonary aeration, gas exchange and ventilatory parameters (endpoints: PaO2/FiO2 and PaCO2, (EELI) = [ΔEELI x (VT/ΔZ)], plateau pressure, driving pressure)
- LP comparisons in SP for 6 hours with LP in PP for 12 hours for pulmonary aeration, gas exchange and ventilatory parameters (endpoints: PaO2/FiO2 and PaCO2, (EELI) = [ΔEELI x (VT/ΔZ)], plateau pressure, driving pressure)
- LP comparisons in PP for 12 hours with return to supine position since 1 hour (End) for pulmonary aeration, gas exchange and ventilatory parameters (endpoints: PaO2/FiO2 and PaCO2, (EELI) = [ΔEELI x (VT/ΔZ)], plateau pressure, driving pressure) : PaO2/FiO2 and PaCO2, (EELI) = [ΔEELI x (VT/ΔZ)], plateau pressure, driving pressure)
- Evaluate the adverse effects related to the use of lateral positioning.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Lateralization using a commercialy available bed (Multicare X LINET)
| Arm | Type | Receives |
|---|---|---|
| Lateral and alterning positioning | Experimental | Other: pulmonary aeration in supine and ventral decubitusBaseline assessment in SP followed by repeated 30-minute lateral decubitus sessions on each side (with a 30° inclination) with a right/left alternation (total duration, 1 hour). During this period, the upper part of the bed will be inclined by 30°. The patients will then be positioned in prone position for a period of 6 hours after which, the same alternating lateral decubitus pattern (repeated 30-minute lateral decubitus sessions on each side with a right/left alternation ) will be applied for 12 hours while the patient is still in prone position. After turning back to the supine position, a 1-hour observation period will be respected before the last measurements are taken. The total duration of the intervention will thus be 20 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Age of at least 18 years
- ARDS evolving for less than 5 days with a PaO2/FiO2 ratio (P/F ratio) < 150 after optimization of PEEP (P/V curve, R/I ratio), curarization and without prior use of the PP since orotracheal intubation.
- Obtained written consent of the patient, one of his relatives or the previously designated trusted person. As soon as possible, the patient will be informed and his written consent will be obtained
- Beneficiary of health insurance coverage
- Possibility of participating in any other studies whose evaluation criteria do not interfere with those of the study
Key exclusion criteria (1 listed)
- Patients who will be unable to complete the 25-hour intervention due to worsening requiring ECMO, death or organizational problems will be excluded from the analysis.
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 |
|---|---|---|
| pulmonary aeration in supine and ventral decubitusThe addition of repeated periods of 30 minutes of lateralization of 30° amplitude in dorsal decubitus and in ventral decubitus in patients with moderate to severe ARDS. Included patients will benefit from sessions of lateral decubitus for 30 minutes on each side (with an inclination of 30°) with alternation right/left (total one hour). During this period, the upper part of the bed will be inclined by 30°. Patients will then be positioned in strict prone position for a period of 6 hours after which, the same pattern of alternating lateral decubitus will be applied for 12 hours while the patient is still in the prone position. After reversal in supine position, an observation period of 1 hour will be respected before carrying out the last measurements. The total duration of the intervention will be 20 hours. | Other | Lateral and alterning positioning |
Primary outcome
modification of pulmonary aeration
Time frame: Up to 25 hours.
Evaluation of the distribution of tidal volume after lateralization and according to the position (supine: SP, prone: PP) by measuring global changes and regional (4 regions of interest from the retro-sternal region to the pre-vertebral region) of ventilation lung assessed by electrical impedance tomography (EIT).The primary endpoint will be the change in pulmonary aeration after lateralization in SP (T2) and in PP (T5) estimated by the variation in end-expiration pulmonary impedance (EELI) = [ΔEELI x (VT/ΔZ)] where VT is the tidal volume and ΔZ the impedance variation.
2 secondary outcomes
Assessment of gas exchange
Time frame: Up to 25 hours
Assessment of lung perfusion
Time frame: Up to 25 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Individual participant dataSharing planned: Yes. Only IPD used in the results 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.
laurent papazian, MD,PHD study director
Bastia General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pulmonary aeration in supine and ventral decubitus in people with ARDS, run by Centre Hospitalier de Bastia at 2 sites in France.
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 23 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurent Papazian, MD,PHD (0495591039, laurent.papazian@ch-bastia.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modification of pulmonary aeration (time frame: Up to 25 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 15 May 2025.