Acute Respiratory Distress SyndromePARAVENTNCT06039215
Paramedical Protocol for Ventilation in Acute Respiratory Distress Syndrome
A study testing Ventilatory adjustments by nurses in people with Acute Respiratory Distress Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Acute respiratory distress syndrome (ARDS) is a frequent pathology in intensive care (around 10% of patients admitted to intensive care and almost a quarter of patients on mechanical ventilation) and a serious one, with a hospital mortality rate of 40%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- Ventilatory adjustments by nurses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2023to 1 Aug 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
- Age ≥ 18 years
- Intensive care hospitalization;
- Intubation with artificial ventilation;
- ARDS evolving for less than 72 hours. ARDS criteria according to the Berlin definition, as follows:
- Exposure to a risk factor for ARDS or onset/aggravation of pulmonary symptoms within the previous 7 days ;
- Respiratory distress not fully explained by cardiac failure or volume overload, with exclusion of hydrostatic edema in the absence of exposure to a risk factor for ARDS;
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- Hypoxemia with PaO2/FiO2 ratio < 300 mm Hg under PEEP ≥ 5 cmH2O ;
- Bilateral opacities on chest X-ray, lung ultrasound or chest CT, not fully explained by pleural effusions, atelectasis or nodules.
- Blood pressure monitoring
- Affiliation to the social security system.
- Written informed consent (patient, relative) or inclusion in emergency situation.
Who cannot join
- Long-term oxygen therapy;
- Pneumothorax or drained pleurisy;
- Documented pulmonary embolism;
- Intracranial hypertension;
- ARDS refractory to inclusion, i.e.: i) oxygen partial pressure on inspired oxygen fraction a ratio (PaO2/FiO2) <80 mm Hg or plateau pressure (Pplat) > 32 cmH2O despite optimization of mechanical ventilation (tidal volume (Vt) set at 6 mL/kg weight predicted by height, FiO2 ≥80% and positive expiratory pressure (PEEP) ≥10 cmH2O) and despite the use of complementary therapies (including prone and/or inhaled nitric oxide); or ii) pH <7. 25 with PaCO2 ≥60 mm Hg;
- ARDS evolving for more than 72 hours with intubation and mechanical ventilation;
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- Patient deprived of liberty;
- Patient under legal protection (guardianship or curatorship);
- Known pregnancy or breast-feeding (a pregnancy test will be performed prior to inclusion in patients of childbearing age).
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique-Hôpitaux de Paris service de santé publique
Créteil, Creteil, 94010
Assistance Publique-Hôpitaux de Paris service de santé publique, 0145178638, samia.baloul@aphp.fr
About this study
Official title: Paramedical Protocol for Ventilation in Acute Respiratory Distress Syndrome: Prospective, Multicenter, Randomized, Controlled, Open-label, Phase III, Cluster Trial With Sequential Permutation
Acute respiratory distress syndrome (ARDS) is a frequent pathology in intensive care (around 10% of patients admitted to intensive care and almost a quarter of patients on mechanical ventilation) and a serious one, with a hospital mortality rate of 40%. The main measures that have an effect on mortality in ARDS involve adjustments to the ventilator, known as protective ventilation. In the most severe patients, adjuvant measures such as prone positioning and the use of curarisation in the initial phase of the disease can improve survival. All these measures have been included in the latest national and international recommendations. However, a vast observational study carried out in 50 countries revealed low compliance with these recommendations. More than a third of patients did not receive protective ventilation, and the majority did not receive prone positioning when this was indicated. During weaning from artificial ventilation, it has been widely demonstrated that replacing clinician judgement with the implementation of paramedical care protocols improved weaning and significantly reduced the duration of artificial ventilation. Therefore, investigators hypothesize that the implementation of a paramedical care protocol for ventilation in the acute phase of ARDS improves compliance with recommendations and thus reduces mortality and the duration of artificial ventilation. However, implementation of such a protocol requires operational training for all the nurses in the participating departments. Simulation appears to be the training method of choice, as it is a teaching technique that enables technical and non-technical skills to be passed on with good retention of what has been learnt, as well as assessing what has been learnt. To make it possible to train several dozen nurses within a tight timescale, a partially dematerialized simulation model incorporating innovative e-learning tools will be developed.
- Conditions
- Acute Respiratory Distress Syndrome
- Being tested
- Ventilatory adjustments by nurses
- Keywords
- Acute respiratory distress syndrome, ARDS, Paramedical care protocol, Mortality
- 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.
Ventilatory adjustments by nursesOther
Also called Post-intervention period
Respirator settings are adjusted by nurses according to a pre-established care protocol that complies with international recommendations. The nurse assesses the patient's respiratory status and readjusts the artificial respirator settings if necessary, at least twice a day.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Respirator settings are adjusted by nurses according to a pre-established care protocol that complies with international recommendations. The nurse assesses the patient's respiratory status and readjusts the artificial respirator settings if necessary, at least twice a day. Receives: Other: Ventilatory adjustments by nurses |
| Control group | No intervention | The ventilator settings are adjusted in line with the centre's usual practice. No change from usual management of acute respiratory distress syndrome. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate and number of days without mechanical ventilation
The primary endpoint will be a combination of mortality and the number of days without mechanical ventilation at D28. This composite criterion will be prioritised so that survival is given priority in the analysis over the shorter duration of mechanical ventilation.
Measured: 28 days
Secondary outcomes (19)
Mesure of tidal volume ventilation
Measured: Up to Day 7
Mesure of plateau pressure
Measured: Up to Day 7
Mesure of positive end-expiratory pressure (PEEP)
Measured: Up to Day 7
Mesure of FiO2
Measured: Up to Day 7
Oxygenation
arterial blood gases and SpO2
Measured: Up to Day 7
Number of days without mechanical ventilation
Measured: Up to Day 28
Number of days without catecholamine
Measured: Up to Day 28
Number of days without continuous sedation
Measured: Up to Day 28
Duration of mechanical ventilation .
from intubation to successful extubation
Measured: Up to Day 28
Occurrence of mechanically ventilated pneumothorax
Measured: Up to Day 28
Duration of Acute respiratory distress syndrome
defined as the day on which the 1st test of spontaneous ventilation was performed
Measured: UP to Day 28
Duration of weaning from mechanical ventilation
measured as the time between the 1st test of spontaneous ventilation and successful extubation (patient alive and without reintubation within 7 days of extubation).
Measured: Up to Day 28
Number of participants with rescue therapy
Measured: Up to Day 28
Rate of re-intubation
Measured: Up to Day 28
Rate of use of non-invasive ventilation and curative high-flow oxygen therapy
Measured: Up to Day 28
Tracheostomy rate
Measured: Up to Day 28
Length of stay in intensive care and in hospital.
Measured: Up to day 28
Number of deaths in ICU and hospital
Measured: Up to Day 28
Number of nurses trained in paramedical protocol per center.
Measured: Up to 26 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start1 Oct 2023 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Aug 2025 (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.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- This is a prospective, multicenter, randomized, controlled, open-label, phase III, stepped wedge cluster randomized design. This experimental design involves the sequential implementation of an intervention in the clusters included over several periods. The order in which the clusters received the intervention was determined by drawing lots; at the end of the study, all the clusters received the intervention at some point and were observed during a pre- and post-intervention control period (each cluster "is its own control").
- Masking
- None (open label)
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06039215
- Sponsor's protocol ID
- APHP191098
- Other IDs
- 2022-A02716-37
- Acronym
- PARAVENT
- Status last verified
- Sep 2023
- First submitted
- 12 Jul 2023
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paramedical Protocol for Ventilation in Acute Respiratory Distress Syndrome: Prospective, Multicenter, Randomized, Controlled, Open-label, Phase III, Cluster Trial With Sequential Permutation
- ClinicalTrials.gov ID
- NCT06039215
- Acronym / sponsor ID
- PARAVENT / APHP191098
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- Acute respiratory distress syndrome, ARDS, Paramedical care protocol, Mortality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 15 Sep 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.
Acute respiratory distress syndrome (ARDS) is a frequent pathology in intensive care (around 10% of patients admitted to intensive care and almost a quarter of patients on mechanical ventilation) and a serious one, with a hospital mortality rate of 40%. The main measures that have an effect on mortality in ARDS involve adjustments to the ventilator, known as protective ventilation. In the most severe patients, adjuvant measures such as prone positioning and the use of curarisation in the initial phase of the disease can improve survival. All these measures have been included in the latest national and international recommendations. However, a vast observational study carried out in 50 countries revealed low compliance with these recommendations. More than a third of patients did not receive protective ventilation, and the majority did not receive prone positioning when this was indicated. During weaning from artificial ventilation, it has been widely demonstrated that replacing clinician judgement with the implementation of paramedical care protocols improved weaning and significantly reduced the duration of artificial ventilation. Therefore, investigators hypothesize that the implementation of a paramedical care protocol for ventilation in the acute phase of ARDS improves compliance with recommendations and thus reduces mortality and the duration of artificial ventilation. However, implementation of such a protocol requires operational training for all the nurses in the participating departments. Simulation appears to be the training method of choice, as it is a teaching technique that enables technical and non-technical skills to be passed on with good retention of what has been learnt, as well as assessing what has been learnt. To make it possible to train several dozen nurses within a tight timescale, a partially dematerialized simulation model incorporating innovative e-learning tools will be developed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective, multicenter, randomized, controlled, open-label, phase III, stepped wedge cluster randomized design. This experimental design involves the sequential implementation of an intervention in the clusters included over several periods. The order in which the clusters received the intervention was determined by drawing lots; at the end of the study, all the clusters received the intervention at some point and were observed during a pre- and post-intervention control period (each cluster "is its own control").
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Ventilatory adjustments by nursesRespirator settings are adjusted by nurses according to a pre-established care protocol that complies with international recommendations. The nurse assesses the patient's respiratory status and readjusts the artificial respirator settings if necessary, at least twice a day. |
| Control group | No intervention | –The ventilator settings are adjusted in line with the centre's usual practice. No change from usual management of acute respiratory distress syndrome. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 18 years
- Intensive care hospitalization;
- Intubation with artificial ventilation;
- ARDS evolving for less than 72 hours. ARDS criteria according to the Berlin definition, as follows:
- Blood pressure monitoring
Key exclusion criteria (9 listed)
- Long-term oxygen therapy;
- Pneumothorax or drained pleurisy;
- Documented pulmonary embolism;
- Intracranial hypertension;
- ARDS refractory to inclusion, i.e.: i) oxygen partial pressure on inspired oxygen fraction a ratio (PaO2/FiO2) <80 mm Hg or plateau pressure (Pplat) > 32 cmH2O despite optimization of mechanical ventilation (tidal volume (Vt) set at 6 mL/kg weight predicted by height, FiO2 ≥80% and positive expiratory pressure (PEEP) ≥10 cmH2O) and despite the use of complementary therapies (including prone and/or inhaled nitric oxide); or ii) pH <7. 25 with PaCO2 ≥60 mm Hg;
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 |
|---|---|---|
| Ventilatory adjustments by nursesAlso: Post-intervention periodRespirator settings are adjusted by nurses according to a pre-established care protocol that complies with international recommendations. The nurse assesses the patient's respiratory status and readjusts the artificial respirator settings if necessary, at least twice a day. | Other | Experimental group |
Primary outcome
Mortality rate and number of days without mechanical ventilation
Time frame: 28 days
The primary endpoint will be a combination of mortality and the number of days without mechanical ventilation at D28. This composite criterion will be prioritised so that survival is given priority in the analysis over the shorter duration of mechanical ventilation.
19 secondary outcomes
Mesure of tidal volume ventilation
Time frame: Up to Day 7
Mesure of plateau pressure
Time frame: Up to Day 7
Mesure of positive end-expiratory pressure (PEEP)
Time frame: Up to Day 7
Mesure of FiO2
Time frame: Up to Day 7
Oxygenation
Time frame: Up to Day 7
Number of days without mechanical ventilation
Time frame: Up to Day 28
Number of days without catecholamine
Time frame: Up to Day 28
Number of days without continuous sedation
Time frame: Up to Day 28
Duration of mechanical ventilation .
Time frame: Up to Day 28
Occurrence of mechanically ventilated pneumothorax
Time frame: Up to Day 28
Duration of Acute respiratory distress syndrome
Time frame: UP to Day 28
Duration of weaning from mechanical ventilation
Time frame: Up to Day 28
Number of participants with rescue therapy
Time frame: Up to Day 28
Rate of re-intubation
Time frame: Up to Day 28
Rate of use of non-invasive ventilation and curative high-flow oxygen therapy
Time frame: Up to Day 28
Tracheostomy rate
Time frame: Up to Day 28
Length of stay in intensive care and in hospital.
Time frame: Up to day 28
Number of deaths in ICU and hospital
Time frame: Up to Day 28
Number of nurses trained in paramedical protocol per center.
Time frame: Up to 26 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Individual participant dataSharing planned: No. DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
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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.
Assistance Publique-Hôpitaux de Paris service de santé publique
Créteil, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ventilatory adjustments by nurses in people with Acute Respiratory Distress Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 11 inclusion and 9 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 15 Sep 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality rate and number of days without mechanical ventilation (time frame: 28 days). 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 Sep 2023.