Clinical trial NCT06039215: Paramedical Protocol for Ventilation in Acute Respiratory Distress Syndrome
Official title: Paramedical Protocol for Ventilation in Acute Respiratory Distress Syndrome: Prospective, Multicenter, Randomized, Controlled, Open-label, Phase III, Cluster Trial With Sequential Permutation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Acute Respiratory Distress Syndrome
Keywords: Acute respiratory distress syndrome
ARDS
Paramedical care protocol
Mortality
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-09-15
Enrollment: 540
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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").
Primary purpose: TREATMENT

Brief 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%. 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.


Eligibility criteria: Inclusion Criteria:

* 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;
  * 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.

Exclusion Criteria:

* 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;
* 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).

Primary outcomes:
measure: Mortality rate and number of days without mechanical ventilation
timeFrame: 28 days
Secondary outcomes:
measure: Mesure of tidal volume ventilation
timeFrame: Up to Day 7
measure: Mesure of plateau pressure
timeFrame: Up to Day 7
measure: Mesure of positive end-expiratory pressure (PEEP)
timeFrame: Up to Day 7
measure: Mesure of FiO2
timeFrame: Up to Day 7
measure: Oxygenation
timeFrame: Up to Day 7
measure: Number of days without mechanical ventilation
timeFrame: Up to Day 28
measure: Number of days without catecholamine
timeFrame: Up to Day 28
measure: Number of days without continuous sedation
timeFrame: Up to Day 28
measure: Duration of mechanical ventilation .
timeFrame: Up to Day 28
measure: Occurrence of mechanically ventilated pneumothorax
timeFrame: Up to Day 28
measure: Duration of Acute respiratory distress syndrome
timeFrame: UP to Day 28
measure: Duration of weaning from mechanical ventilation
timeFrame: Up to Day 28
measure: Number of participants with rescue therapy
timeFrame: Up to Day 28
measure: Rate of re-intubation
timeFrame: Up to Day 28
measure: Rate of use of non-invasive ventilation and curative high-flow oxygen therapy
timeFrame: Up to Day 28
measure: Tracheostomy rate
timeFrame: Up to Day 28
measure: Length of stay in intensive care and in hospital.
timeFrame: Up to day 28
measure: Number of deaths in ICU and hospital
timeFrame: Up to Day 28
measure: Number of nurses trained in paramedical protocol per center.
timeFrame: Up to 26 months
Other outcomes:
Locations:
city: Créteil
country: France
facility: Assistance Publique-Hôpitaux de Paris service de santé publique
state: Creteil
Study officials:
References: