Paramedical Protocol for Ventilation in Acute Respiratory Distress Syndrome

NCT ID: NCT06039215

Last Updated: 2023-09-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 540 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2025-08-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental group

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.

Group Type: EXPERIMENTAL

Ventilatory adjustments by nurses

Intervention Type: 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.

Control group

The ventilator settings are adjusted in line with the centre's usual practice. No change from usual management of acute respiratory distress syndrome.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Ventilatory adjustments by nurses

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.

Intervention Type: OTHER

Other Intervention Names

Post-intervention period

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Assistance Publique-Hôpitaux de Paris service de santé publique

Créteil, Creteil, France

Countries

France

Facility Contacts

Assistance Publique-Hôpitaux de Paris service de santé publique

Role: primary

samia.baloul@aphp.fr

0145178638

Other Identifiers

2022-A02716-37

Identifier Type: OTHER

Identifier Source: secondary_id

APHP191098

Identifier Type: -

Identifier Source: org_study_id