Nervous System Diseases

Heart and Blood Diseases

All Conditions

Stroke

Epilepsy

Brain Diseases

Central Nervous System Diseases

High-density EEG will be used for brain localization in epilepsy patients

High-density EEG will be used for brain localization in healthy controls

High-density EEG will be used for brain localization in tumor patients

High-density EEG will be used for brain localization in patients with peripheral nerve dysfunction

High-density EEG will be used for brain localization in patients who have recently experienced a stroke

This study will focus on obtaining a special type of high-density scalp electroencephalography (HD-EEG) recordings in patients with neurological disorders (i.e., epilepsy, brain tumor, stroke, etc.) and appropriately matched controls. HD-EEG is a scalp EEG which uses up to 256 channels compared to the standard 21 channels used for routine clinical applications. The reason for using more channels to record is for more precise localization of epileptogenic foci and/or more precise mapping of brain functions. This type of EEG requires the use of patient's own MRI scan to precisely localize activity. Therefore, all patients and controls getting an HD-EEG will require a structural MRI scan.

High-density electroencephalogram (HD-EEG)

The purpose of the study is to use a new method of high-density electroencephalogram (HD-EEG) recording to map brain areas important for movement, sensation, language, emotion, and cognition.

This study will measure brain waves using high-density EEG. Participants will be asked wear a cap with electrodes attached to it. During the recording, participants may be asked to rest, sleep, or complete a task. The tasks involve viewing pictures, answering questions, speaking, or moving an arm or leg. Recordings generally last between 60-120 minutes.\*

High-density EEG in Neurological Disorders

Localize brain functions using high-density EEG recordings

Localize brain areas involved in language using high-density EEG recordings

Localize brain areas involved in movement using high-density EEG recordings

Localize brain areas involved in sensation using high-density EEG recordings

Localize brain areas involved in emotion using high-density EEG recordings

Localize brain areas involved in memory using high-density EEG recordings

Localize brain areas associated with lesions using high-density EEG recordings

Dartmouth-Hitchcock Medical Center

Clinical Neurophysiologist, Neuro Diagnostics

Neoplasms

Digestive System Diseases

Symptoms and General Pathology

Respiratory Tract (Lung and Bronchial) Diseases

Diseases and Abnormalities at or Before Birth

Infections

Rare Diseases

Stomach Neoplasms

Syndrome

Lung Diseases

Liver Diseases

Respiratory Distress Syndrome

Respiratory Distress Syndrome, Newborn

Acute Lung Injury

Pulmonary Atelectasis

Pneumonia

Edema

Pleural Effusion

Pneumothorax

Pancreatic Diseases

Pulmonary Edema

Airway Obstruction

Gastrointestinal Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Stomach Diseases

Stomach Cancer

Respiratory Distress Syndrome, Infant

Acute Respiratory Distress Syndrome

Acute Graft Versus Host Disease

Hematinics

All Drugs and Chemicals

Liver Extracts

Marc Bodenstein

The purpose of this study is to determine whether Electrical Impedance Tomography can be used as sensitive and specific predictor in the detection of postoperative pulmonary complications (e.g. pneumonia, bronchitis, acute respiratory distress syndrome, pleural effusion, pneumothorax, pulmonary edema, atelectasis, pulmonary embolism, hypoxemia, hypercapnia, spasms and obstructions of the airway) in patients undergoing epigastric surgery.

* Study cycle:

  1. Check of criteria of inclusion/exclusion
  2. Informed consent
  3. Recording preoperative data via paper case report form
  4. Preoperative EIT measurement
  5. Postoperative EIT measurement
  6. Recording postoperative data via paper case report form

     Patients therapy and any diagnostic investigation during hospital stay (apart from EIT measurement) are performed appropriate to patients individual clinical needs and are independent from participation in this clinical trial. As PPC may result from surgical complications (e.g. intra- /postoperative bleeding, anastomotic leak, infection of the wound, injury of neighboring organs) they are monitored.
* Statistical analysis:

Sample size:

After consultation of Johannes-Gutenberg-University Institute of Medical Biometry and Epidemiology the following procedure was developed: Pre-analysis with 20 patients, then determination of definitive sample size (advised 80 patients).

Population:

Any registered patient is included in population even if no study-treatment was performed. To fulfill Pre-Protocol-Population-criteria EIT-measurement has to be performed before and after elective epigastric surgery and information about PPC must be revealable from patients medical file/records.

* Analysis of efficacy:

  1. Primary objective:

     (A) Incidence of any PPC (postoperative pulmonary complication) until postoperative day 7; Acquisition of PPC might require diagnostic investigation during hospital stay; investigations are only performed appropriate to patients individual clinical needs. As PPC are defined:
     * I: desaturation, increased oxygen demand (data from electronic health record)
     * II: dys-/atelectasis, pleural effusion, pneumothorax, pulmonary vein congestion (data from thoracic x-ray)
     * III: detected respiratory infection/pneumonia, pulmonary edema, Aspiration, non-invasive/CPAP-Ventilation, necessity of pleural drain/of bronchoscopy (data from electronic health record, x-ray)
     * IV: Reintubation (data from electronic health record), ARDS (according to Berlin Definition)

     (B) regional Distribution of Ventilation (Analysis of EIT raw data pre- and postoperative in 4 regions of interest: ventral, mid-ventral, mid-dorsal, dorsal; correlation between PPC and difference in regional Distribution of Ventilation at defined moment)
  2. Secondary objective: post-hoc Analysis (see down Secondary Outcome Measure)

     Average, Median, Quartile, Standard Deviation are detected and shown in Box-plots (type of graphic). Explorative comparison of parameters is effected by t-Test, Mann-Whitney-U-Test, Fisher-Test dependent on normal distribution.
* Quality assurance and data management Design, execution and analyzation of the study is ICH-GCP-conform (Good-Clinical-Practice-Guideline of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use). All responsible persons are obliged to good clinical practice. All changes in study protocol are to be authorized by responsible Ethics Committee. The P.I. is responsible for source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources (e.g., medical records, paper or electronic case report forms).

Prior to written informed consent all patients are to be informed about character and consequences of the study. With their signature patients permit collection and use of source data. Every patient receives an Identification code for pseudonymization of data. Analyzation and publication of data is effected anonymously only. Data collection is mainly provided in an electronic data base, besides in a paper-based Case Report Form. All electronic and paper-based data and archived in our Clinical Research Center and are accessible for authorized persons (Monitor, Auditor). The study protocol does not provide audits.

Amendment after Pre-analysis:

We conducted a preliminary study of 23 patients for sample size calculation, aligned with the goal of predicting probability of relevant PPC. Power calculation was based on the assumption that 50 % of patients would develop relevant PPC. We performed a power analysis using the Wilcoxon test. The assumption was that AUC of EIT-parameters for distinguishing PPC-affected patients from non-affected patients would be at least 0.65. In order to demonstrate that AUC is indeed above 0.5, a Wilcoxon test can be applied. AUC=0.65 translates into P(X\<Y)=0.65. To demonstrate this at the 5%-significance level with a power of 80%, 116 patients are needed. Considering that approximately 10% of patients may not be evaluable, a total sample size of 130 patients was determined. Interim analysis revealed, that incidence of relevant PPC in the study cohort was lower than assumed in sample size calculation. Therefore a higher sample size was necessary than expected. Furthermore, recruiting was slow. We therefore switched from a confirmatory to a descriptive approach.

Screening of Postoperative Pulmonary Complications by Electrical Impedance Tomography

Screening of Postoperative Pulmonary Complications by Electrical Impedance Tomography in Intensive Care Patients Undergoing Epigastric Surgery

Comparison of the changed regional ventilation partition to the occurence of postoperative pulmonary complications =\> calculation of sensitivity and specifity of the primary outcome measure to predict PPC. Statistical analysis: receiver operating characteristic (ROC curve).

Sensitivity and specifiy for appearance of PPC (Postoperative Pulmonary Complications) within Postoperative Day 1-7.

Statistical analysis: Sensitivity, Specificity, ROC-curve

Correlation of pre-existing pathologic pulmonary conditions with specific postoperative changes in regional distribution of lung ventilation and perfusion assessed by EIT Statistical analysis: Sensitivity, Specificity, ROC-curve

Appearance of all different forms of PPC within Postoperative Day 1-7 and relation to postoperative EIT-measure (ROI analysis in 8 pulmonary ROIs).

Statistical analysis: Sensitivity, Specificity, ROC-curve

Sensitivity and specifity of postoperative EIT-measure for mortality. Statistical analysis: Sensitivity, Specificity, ROC-curve

Sensitivity and specifity of postoperative EIT-measure for time of intensive care therapy.

Statistical analysis: Sensitivity, Specificity, ROC-curve

Sensitivity and specifity of postoperative EIT-measure for Ventilator-obligatory-free days.

Statistical analysis: Sensitivity, Specificity, ROC-curve

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
High-density EEG in Neurological Disorders	NCT04266041	Epilepsy Tumor Healthy	High-density el...	18 Years -	Dartmouth-Hitchcock Medical Center
Screening of Postoperative Pulmonary Complications by Electrical Impedance Tomography	NCT02337673	Pulmonary Disea... Postoperative R... Malignant Neopl... Liver Diseases Pancreatic Dise...		18 Years -	Johannes Gutenberg University Mainz

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