Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-25 @ 4:02 AM
NCT ID:
NCT02687802
Brief Summary:
The objective of the study is to estimate the incidence of asynchrony and to assess its relationship with respiratory mechanics. This will be a prospective cohort study, including patients under invasive mechanical ventilation. Within 48h post intubation, the investigators will record the values of intrinsic positive end-expiratory pressure, pulmonary compliance and resistance. Participants will be followed up from intubation to mechanical ventilation liberation. The investigators will register clinical signs of asynchrony and record ventilator waveforms continuously and quantify patient-ventilator asynchrony. The investigators will calculate the total asynchrony index (AI) and of each asynchrony type (ineffective triggering, double triggering, auto triggering, short cycling and prolonged cycling). Participants will be followed up until hospital discharge.
Detailed Description:
Patient-ventilator asynchrony is common in patients under invasive mechanical ventilation, present between 10 and 80% of all respiratory cycles, and is associated with adverse clinical outcomes, such as delay in the weaning process, increased complications of mechanical ventilation, with possible impact on survival. The objective of this study is to estimate the incidence of asynchrony and to assess its relationship with respiratory mechanics. This will be a prospective cohort study, including all patients under invasive mechanical ventilation admitted at Respiratory ICU at Hospital das Clínicas da Faculdade de Medicina da Universidade de Sao Paulo (USP), during the study period. Within 48h post intubation, the investigators will record the values of intrinsic positive end-expiratory pressure, pulmonary compliance and resistance. Participants will be followed up from intubation to mechanical ventilation liberation. The investigators will register clinical signs of asynchrony and record ventilator waveforms continuously. The ventilator waveforms will be captured directly from ventilator and processed by dedicated software, without direct contact with patients. Later, ventilator waveforms will be analyzed to quantify patient-ventilator asynchrony. The investigators will calculate the total asynchrony index (AI) and of each asynchrony type (ineffective triggering, double triggering, auto triggering, short cycling and prolonged cycling). Participants will be followed up until hospital discharge, and the investigators will record duration of mechanical ventilation, the use of non-invasive ventilation post-extubation, reintubation, tracheostomy, ICU and hospital length of stay and survival. With this project, the investigators will estimate the incidence and magnitude of patient-ventilator asynchrony and its association with clinical outcomes
Study:
NCT02687802
Study Brief:
Protocol Section:
NCT02687802