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EPISYNC study: predictors of patient-ventilator asynchrony in a prospective cohort of patients under invasive mechanical ventilation - study protocol.

ABSTRACT: INTRODUCTION:Patient-ventilator asynchrony is common during the entire period of invasive mechanical ventilation (MV) and is associated with worse clinical outcomes. However, risk factors associated with asynchrony are not completely understood. The main objectives of this study are to estimate the incidence of asynchrony during invasive MV and its association with respiratory mechanics and other baseline patient characteristics. METHODS AND ANALYSIS:We designed a prospective cohort study of patients admitted to the intensive care unit (ICU) of a university hospital. Inclusion criteria are adult patients under invasive MV initiated for less than 72?hours, and with expectation of remaining under MV for more than 24?hours. Exclusion criteria are high flow bronchopleural fistula, inability to measure respiratory mechanics and previous tracheostomy. Baseline assessment includes clinical characteristics of patients at ICU admission, including severity of illness, reason for initiation of MV, and measurement of static mechanics of the respiratory system. We will capture ventilator waveforms during the entire MV period that will be analysed with dedicated software (Better Care, Barcelona, Spain), which automatically identifies several types of asynchrony and calculates the asynchrony index (AI). We will use a linear regression model to identify risk factors associated with AI. To assess the relationship between survival and AI we will use Kaplan-Meier curves, log rank tests and Cox regression. The calculated sample size is 103 patients. The statistical analysis will be performed by the software R Programming (www.R-project.org) and will be considered statistically significant if the p value is less than 0.05. ETHICS AND DISSEMINATION:The study was approved by the Ethics Committee of Instituto do Coração, School of Medicine, University of São Paulo, Brazil, and informed consent was waived due to the observational nature of the study. We aim to disseminate the study findings through peer-reviewed publications and national and international conference presentations. TRIAL REGISTRATION NUMBER:NCT02687802; Pre-results.

SUBMITTER: Sousa MLA

PROVIDER: S-EPMC6537972 | biostudies-literature | 2019 May

REPOSITORIES: biostudies-literature

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Project description:Introduction and aim:Studies regarding asynchrony in patients in the cardiac postoperative period are still only a few. The main objective of our study was to compare asynchronies incidence and its index (AI) in 3 different modes of ventilation (volume-controlled ventilation [VCV], pressure-controlled ventilation [PCV] and pressure-support ventilation [PSV]) after ICU admission for postoperative care. Methods:A prospective parallel randomised trialin the setting of a non-profitable hospital in Brazil. The participants were patients scheduled for cardiac surgery. Patients were randomly allocated to VCV or PCV modes of ventilation and later both groups were transitioned to PSV mode. Results:All data were recorded for 5 minutes in each of the three different phases: T1) in assisted breath, T2) initial spontaneous breath and T3) final spontaneous breath, a marking point prior to extubation. Asynchronies were detected and counted by visual inspection method by two independent investigators. Reliability, inter-rater agreement of asynchronies, asynchronies incidence, total and specific asynchrony indexes (AIt and AIspecific) and odds of AI ?10% weighted by total asynchrony were analysed. A total of 17 patients randomly allocated to the VCV (n=9) or PCV (n=8) group completed the study. High inter-rated agreement for AIt (ICC 0.978; IC95%, 0,963-0.987) and good reliability (r=0.945; p<0.001) were found. Eighty-two % of patients presented asynchronies, although only 7% of their total breathing cycles were asynchronous. Early cycling and double triggering had the highest rates of asynchrony with no difference between groups. The highest odds of AI ?10% were observed in VCV regardless the phase: OR 2.79 (1.36-5.73) in T1 vs T2, p=0.005; OR 2.61 (1.27-5.37) in T1 vs T3, p=0.009 and OR 4.99 (2.37-10.37) in T2 vs T3, p<0.001. Conclusions:There was a high incidence of breathing asynchrony in postoperative cardiac patients, especially when initially ventilated in VCV. VCV group had a higher chance of AI ?10% and this chance remained high in the following PSV phases.

Project description:BACKGROUND:Patient-ventilator asynchrony is common in mechanically ventilated patients and may be related to adverse outcomes. Few studies have reported the occurrence of asynchrony in brain-injured patients. We aimed to investigate the prevalence, type and severity of patient-ventilator asynchrony in mechanically ventilated patients with brain injury. METHODS:This prospective observational study enrolled acute brain-injured patients undergoing mechanical ventilation. Esophageal pressure monitoring was established after enrollment. Flow, airway pressure, and esophageal pressure-time waveforms were recorded for a 15-min interval, four times daily for 3 days, for visually detecting asynchrony by offline analysis. At the end of each dataset recording, the respiratory drive was determined by the airway occlusion maneuver. The asynchrony index was calculated to represent the severity. The relationship between the prevalence and the severity of asynchrony with ventilatory modes and settings, respiratory drive, and analgesia and sedation were determined. Association of severe patient-ventilator asynchrony, which was defined as an asynchrony index ???10%, with clinical outcomes was analyzed. RESULTS:In 100 enrolled patients, a total of 1076 15-min waveform datasets covering 330,292 breaths were collected, in which 70,156 (38%) asynchronous breaths were detected. Asynchrony occurred in 96% of patients with the median (interquartile range) asynchrony index of 12.4% (4.3%-26.4%). The most prevalent type was ineffective triggering. No significant difference was found in either prevalence or asynchrony index among different classifications of brain injury (p?>?0.05). The prevalence of asynchrony was significantly lower during pressure control/assist ventilation than during other ventilatory modes (p?<?0.05). Compared to the datasets without asynchrony, the airway occlusion pressure was significantly lower in datasets with ineffective triggering (p?<?0.001). The asynchrony index was significantly higher during the combined use of opioids and sedatives (p?<?0.001). Significantly longer duration of ventilation and hospital length of stay after the inclusion were found in patients with severe ineffective triggering (p?<?0.05). CONCLUSIONS:Patient-ventilator asynchrony is common in brain-injured patients. The most prevalent type is ineffective triggering and its severity is likely related to a long duration of ventilation and hospital stay. Prevalence and severity of asynchrony are associated with ventilatory modes, respiratory drive and analgesia/sedation strategy, suggesting treatment adjustment in this particular population. Trial registration The study has been registered on 4 July 2017 in ClinicalTrials.gov (NCT03212482) ( https://clinicaltrials.gov/ct2/show/NCT03212482 ).

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EPISYNC study: predictors of patient-ventilator asynchrony in a prospective cohort of patients under invasive mechanical ventilation - study protocol.

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