About this trial
The aim of this project is to achieve useful, universal and standardized definitions for the diagnosis and prevention of ventilator-associated neumonia in patients in the Neonatal Intensive Care Unit (NICU). To this end, a set of recommendations and best practice protocols have been developed in which the healthcare team of the participating units will be trained. These protocols will include evidence-based recommendations for daily practice (oral care, suctioning practices, patient positioning...) and guidelines for the diagnosis, with the goal of improving and standardizing the care that is currently carried out in each unit.
To evaluate the extent to which this intervention helps to reduce the frequency of ventilator-associated pneumonia and minimize its impact, a surveillance registry of the patient on invasive mechanical ventilation will be carried out. This registry consists of the collection of general data (sex, type of delivery, gestational age...), the drugs used during the registry (use or not of antibiotics) and the duration of the period during which the patient is under surveillance. If the patient develops pneumonia during the duration of intubation, the clinical and radiological (and in some cases microbiological) data necessary for its diagnosis and the treatment used will be collected.
The study is composed of several phases, but if we exclude the phases of formation and structure of the teams, literature review, resource preparation and data processing, the study is composed of 3 clearly differentiated phases in which patients are included. In the first phase, the coordinating team will only give the researchers of each hospital access to the forms and a brief explanation of how to fill them in, but instructing them to follow the usual diagnostic criteria. Once an established period of time has finished, the whole team belonging to the NICUs included in the project will be trained. Finally, after the training period, the teams will incorporate the preventive measures and diagnostic criteria seen in the training to their usual practice. To track behavioral changes from one phase to the next, the researchers will fill out forms to monitor the implementation of measures. Once this last phase has been completed, the results obtained will be analysed and the changes in prevention and diagnosis will be evaluated.
Eligibility criteria
Qualifiers
Patients admitted to participating NICUs who are in IMV for at least 48 hours, regardless of birth weight, gestational age or medical condition.
Disqualifiers
Patients who remain in IMV less than 48 hours.
Decision of the healthcare professional in charge of the patient's treatment to exclude their participation at any moment due to the considerations of necessity.
Trial design
Treatments tested in this trial
- Multimodal intervention to reduce the incidence of ventilator-associated pneumonia by training the health care team in specific and general evidence-based good clinical practices.
- Technique with a blind-protected catheter
Treatment groups
Sponsors and collaborators
Biobizkaia Health Research Institute
Lead sponsor
Carlos III Health Institute
Collaborator
Instituto de Investigacion Sanitaria La Fe
Collaborator
European Union
Collaborator
Hospital Universitario 12 de Octubre
Collaborator
Hospital HM Montepríncipe
Collaborator
Hospital General Universitario Gregorio Marañon
Collaborator
Hospital Universitario La Paz
Collaborator
Clinica Universidad de Navarra, Universidad de Navarra
Collaborator
Hospital General Universitario de Castellón
Collaborator
Hospital Clínico Universitario de Valencia
Collaborator
Hospital Donostia
Collaborator
Hospital de Basurto
Collaborator
Complejo Hospitalario Universitario de Pontevedra
Collaborator
Hospital Universitario de Burgos
Collaborator
Hospital Clinico Universitario de Santiago
Collaborator
Hospital Universitari de la Vall de Hebron
Collaborator
Hospital of Navarra
Collaborator
Hospital San Pedro de Alcantara
Collaborator
Hospital Materno-Infantil de Canarias. Las Palmas de Gran Canaria. Spain
Collaborator
Hospital Universitario Central de Asturias
Collaborator
Hospital Universitario Marqués de Valdecilla
Collaborator
Hospitales Universitarios Virgen del Rocío
Collaborator
Complejo Hospitalario de Jaen
Collaborator
Hospital Universitario Puerta del Mar
Collaborator
Hospital Universitario de Jerez de la Frontera
Collaborator
Hospital Materno-Infantil de Málaga
Collaborator
Hospital General Universitario Santa Lucía
Collaborator
Hospital Universitario Virgen de la Arrixaca
Collaborator
Hospital Universitario La Fe
Collaborator
Salamanca University Hospital
Collaborator
Complexo Hospitalario Universitario de A Coruña
Collaborator
Red Salud Materno Infantil y del Desarrollo
Collaborator
Hospital de la Santa creu i Sant Pau - Barcelona
Collaborator
University Hospital Virgen de las Nieves
Collaborator
Germans Trias i Pujol Hospital
Collaborator
Hospital del Rio Hortega
Collaborator
Hospital Arnau de Vilanova
Collaborator