An observational study in Trauma and General Anaesthetic Drug Overdose, sponsored by Romanian Society of Anesthesia and Intensive Care. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-29.
Sponsored by Romanian Society of Anesthesia and Intensive Care · Observational
The critically ill polytrauma patient is one of the most complex cases with regard to the optimization of the intensive care, anesthesia, as well as postoperative management. One of the most important steps in the complex management of such patients is the modulation of anesthesia and the volemic resuscitation, especially in the first hours post-trauma, and in the operating room admission. We start with the assumptions that the optimization of anesthesia should depend on each patient, being conducted in an individual manner. We also believe that by individualizing the anesthesia by monitoring the entropy and SPI it is possible to obtain an appropriate management regarding resuscitation and volume replacement. Furthermore it assumes that an adequate anesthesia, and resuscitation singled volume replacement can reduce morbidity and mortality rates as well as the period of stay in the ICU and recovery time.
Objectives
The project aims to aid to the Romanian healthcare system, by assuring new modernized monitoring equipment, specific for the department of anaesthesia and intensive care, for both clinical and paraclinical data, as well as for the existing information for modulation and optimizing of the general anaesthesia used in critically ill polytrauma cases based on modern techniques, such as entropy, and surgical pleth index (SPI). In this way, it aims to create a new prospect of developing a model, which will help the physicians in the decision-making process, hoping to improve the stats in the high morbidity and mortality rates in this specific field of medicine.
Reducing the mortality and increasing the quality of the provided medical services is possible by assuring a modern monitoring system, because critically ill patients should be observed through complex techniques. Furthermore, interpretation and timely synthesis of the biological signals and their correlation with other clinical and laboratory data are useful in modulating general anesthesia in the critically conditions.
General objectives comprise of developing a new research field regarding the international standards of research and combating the economic and social needs of Romania and Europe, by creating a complete protocol, which is innovative and helpful in improving the mortality and morbidity index for polytrauma patients admitted in the intensive care unit (ICU), by means of better monitoring procedures and modulating the anaesthesia and therapeutic management, therefore increasing the efficiency of the public health care system.
The specific objectives of the study are to represent the integration of modern anesthesia methods used for monitoring and optimizing the management of anesthesia and therapy options, depending on each patient as an individual; calculating the severity scores and risk factors, both in the first 24 hours as well as continuously, providing support instruments designed to add to the medical decision making process, and make it possible in a very short time, developing an ergonomic mode, dynamic and standardized viewing of local and distant perioperative anesthetic protocols, modulated by non-invasive modern techniques for anaesthesia monitoring.
Measurements:
All the patients enrolled in the study will have a monitoring sheet from the start, which will contain details regarding the following: a) Demographic data: age, sex, BMI (registered at the time of admission); b) Clinical data: ASA score, ISS score, APACHE II score, trauma mechanism, type of surgical intervention (registered at the time of admission); c) Laboratory data: EAB parameters, complete blood count, fibrinogen, ESR, PCR, total bilirubin (T0 - before orotracheal intubation, T1 - at extubating, T2 - at 24 hours post-operatively, T0 - before orotracheal intubation, T2 - at 24 hours post-operatively; d) Clinical parameters: heart rate, mean blood pressure, SpO2 plethysmography, EtCO2 capnography, entropy, SPI, axillary skin temperature probe, diuresis (T0 - before orotracheal intubation, at an interval of 15 minutes perioperative, T1 - at extubating); e) Perioperative events: hypotension, bradycardia, bronchospams, SpO2 drop (desaturation) lower than 90% via pulse oximetry (Every event should be noted in the monitoring sheet of the study); f) Events related to intubation: laryngospasms, failed intubation, tissue injury resulting from difficult intubating conditions, postoperative airway complications due to difficult intubation (Every event should be noted in the monitoring sheet of the study). The database officer should register all the patient data relevant for the study in electronic format including all details noted in the monitoring sheet.
Statistical Analysis:
For statistically analysis of the study, in concordance to these objectives, a series of statistical tests were utilized which can satisfy all the statistical objectives of the study. For analysis if the normal distributions of continuous data, the Kolmogorov-Smirnov test will be utilized. Similarly, data with a normal distribution were compared using the Student t test and presented as mean with SD. Last but not the least, data with an inhomogeneous distribution will be compared using the Mann-Whitney U test and presented as median. Nominal data will be compared using the chi-square test. For highlighting the statistical differences, a P value less than 0.05 was considered as significant. The statistical analysis of data will be performed computerized with the programs Microsoft Office Excel for Mac 2011 v.14.4.7. (Microsoft Corporation, Bucharest, Romania) and Prism 6 for Mac OS X v.6.0. (GraphPad Software, Inc., San Diego, CA). This analysis consisted, in the calculation of frequencies and the percentages for qualitative variables, as well as the calculation of the arithmetic means and the standard deviations for quantitative variables. The statistical estimation of the results was performed using the criteria decision of the statistical test. Similarly, the lot will be further statistically analyzed for determining the heterogeneity/homogeneity in between the groups. Similarly, for increasing in the transparency between the different groups, patients will be divided into more groups, as presented in this study.
2,217 studies on the registry are indexed under Wounds and Injuries; 441 are open to participants now.
This study's enrollment of 72 is below the median of 169 across 690 observational studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →Romanian Society of Anesthesia and Intensive Care is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Polytrauma patients admitted in OR
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
General Anesthesia using Entropy and Surgical Pleth Index Monitoring
Device: Monitoring
General Anesthesia without Entropy and Surgical Pleth Index (Control Group)
Monitoring
Change of systolic blood pressure baseline
Evaluating the impact of general anesthesia guided with Entropy and SPI on the hemodynamic instability in the critically ill polytrauma patient; hemodynamic instability is represented and characterized by high blood pressure episodes (hypertension), or low blood pressure (hypotension).
Time frame: Change from Baseline Systolic Blood Pressure at 1 hour
Change of heart beat rate baseline
Evaluating the impact of general anesthesia guided with Entropy and SPI on the heart rate in the critically ill polytrauma patient; cardiac rate instability is represented and characterized by high cardiac rate (tachycardia), or low cardiac rate (bradycardia)
Time frame: Change from Baseline heart beat rate at 1 hour
Opioid consumption
Evaluating the opioid consumption by general anesthesia-guided with Entropy and SPI
Time frame: Through study completion, an average of 1 year
No study locations are listed for this record.
Plan to share: No
Ran from Jan 2016 to primary completion in Dec 2016, 11 months.
Of 265 non-industry observational studies under Wounds and Injuries, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 60. This study's 11 months is below that.
Counting every sponsor, half of 312 studies reached it within 28 months; a quarter within 12 and three quarters within 60.
Wounds and Injuries covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Romanian Society of Anesthesia and Intensive Care