Paramedical Protocol for Ventilation in Acute Respiratory Distress Syndrome

NCT06039215 | Unknown

• 2 other identifiers: APHP1910982022-A02716-37
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Distress Syndrome

Keywords

Acute respiratory distress syndrome; ARDS; Paramedical care protocol; Mortality

Outcome Measures

Primary Outcomes (1)

• 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.

  28 days

Secondary Outcomes (19)

• Mesure of tidal volume ventilation

  Up to Day 7

• Mesure of plateau pressure

  Up to Day 7

• Mesure of positive end-expiratory pressure (PEEP)

  Up to Day 7

• Mesure of FiO2

  Up to Day 7

• Oxygenation

  Up to Day 7

Study Arms (2)

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.

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.

Interventions

Ventilatory adjustments by nurses OTHER

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

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ;
• 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.

You may not qualify if:

• Long-term oxygen therapy;
• Pneumothorax or drained pleurisy;
• Documented pulmonary embolism;
• Intracranial hypertension;
• ARDS evolving for more than 72 hours with intubation and mechanical ventilation;
• Patient deprived of liberty;
• Patient under legal protection (guardianship or curatorship);

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Assistance Publique-Hôpitaux de Paris service de santé publique

Créteil, Creteil, 94010, France

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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").

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: September 15, 2023
• Study Start: October 1, 2023
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: September 15, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)