An interventional study of Ventilatory adjustments by nurses in Acute Respiratory Distress Syndrome, sponsored by Assistance Publique - Hôpitaux de Paris. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-15.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Treatment
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.
1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.
This study's planned enrollment of 540 is above the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
ARDS evolving for less than 72 hours. ARDS criteria according to the Berlin definition, as follows:
Exclusion Criteria:
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.
Other: Ventilatory adjustments by nurses
The ventilator settings are adjusted in line with the centre's usual practice. No change from usual management of acute respiratory distress syndrome.
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.
Also known as: Post-intervention period
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.
Time frame: 28 days
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
arterial blood gases and SpO2
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 .
from intubation to successful extubation
Time frame: Up to Day 28
Occurrence of mechanically ventilated pneumothorax
Time frame: Up to Day 28
Duration of Acute respiratory distress syndrome
defined as the day on which the 1st test of spontaneous ventilation was performed
Time frame: 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).
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
Plan to share: No — DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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