Symptoms and General Pathology

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Diseases and Abnormalities at or Before Birth

Wounds and Injuries

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Syndrome

Respiratory Distress Syndrome

Respiratory Distress Syndrome, Newborn

Acute Lung Injury

Lung Injury

Lung Diseases

Respiratory Tract Diseases

Respiration Disorders

Premature Birth

Infant, Premature, Diseases

Infant, Newborn, Diseases

Thoracic Injuries

Respiratory Distress Syndrome, Infant

Acute Respiratory Distress Syndrome

Acute Graft Versus Host Disease

Consecutively admitted patients at GRAACC's PICU with malignancy diagnosis according to IDC-10, in a 24mo consecutive period, under mechanical ventilation for over 24h and with ALI/ARDS criteria, not younger than 29 days or older than 17 years 11 months

Rodrigo G Arduini, MD

Identify pediatric oncologic patients with ALI/ARDS at GRAACC/IOP's Pediatric Intensive Care Unit and evaluate the mechanical ventilation practice in these subjects for a 48mo period.

Evaluate adequate mechanical ventilation based on protective ventilation protocols for children available so far.

Evaluate and describe the subjects. Evaluate the necessity and outcome of rescue therapies (surfactant, prone position, corticosteroids, alveolar recruitment) Obtain data about ALI/ARDS' etiology, mortality rates and predictive factors related to the outcomes (PICU/ hospital discharge or death)

ALI/ARDS in Oncologic Pediatric Patients

Practice of Mechanical Ventilation in Pediatric Oncologic Patients Diagnosed With Acute Lung Injury / Acute Respiratory Distress Syndrome

Type and data about their mechanical ventilation, etiologic factors for ALI/ARDS, mortality rates, predictive factors about outcomes (death/ discharge), necessity and types of rescue therapies (surfactant, prone position, corticosteroids, etc.)

Grupo de Apoio ao Adolescente e a Crianca com Cancer

Infections

Heart and Blood Diseases

Shock

Sepsis

Shock, Cardiogenic

Toxemia

Communicable Diseases

Systemic Inflammatory Response Syndrome

Inflammation

Myocardial Infarction

Infarction

Coronary Artery Disease

Myocardial Ischemia

Ischemia

Heart Diseases

Vascular Diseases

Necrosis

Participants who meet the eligibility criteria of severe sepsis.

Cardiac Magnetic Resonance provides more sensitive measure of ventricular volume and ejection fraction as well as novel markers of tissue characterization and edema assessment.

Cardiac MRI

Anthony Merlocco, MD

Joshua Wolf, MBBS. PhD

The overall purpose of this protocol is to identify subacute sepsis-associated cardiac disease in pediatric patients with cancer by CMR and evaluate the CMR findings during their follow-up. This will help inform heart failure management decision making. Evidence of dysfunction or elevated T2 values may inform adjustment of afterload reduction and beta blocker administration, and elevated ECV findings will suggest the need for increased surveillance for diastolic dysfunction.

Primary Objectives:

(Feasibility Phase) To determine the feasibility of cardiac MRI without anesthesia in the immediate post-sepsis period in children with cancer.

CMR scanning will be completed within 10 days of presentation - this will allow us to ensure that possible hemodynamic or respiratory instability and renal dysfunction has resolved prior to transport to the MRI scanner during the most acute phase of illness.

(Completion Phase) To estimate the frequency of subacute sepsis-associated cardiac disease, including myocardial inflammation and dysfunction, in the post-acute phase (within 10 days of presentation) of severe sepsis in children with cancer

The primary purpose of this study is to evaluate the feasibility of obtaining cardiac MRI in pediatric patients with cancer post-septic shock which will be completed in an initial 5 patients to establish feasibility of successfully completing first study CMR within ten days of sepsis presentation without sedation.

This study will use a two-stage design. The initial stage (the feasibility phase) will evaluate the feasibility of data collection, and the second stage (the completion phase) will provide data for analysis of cardiovascular abnormalities and recovery in sepsis.

Feasibility Phase

The feasibility phase of the study will comprise the first 5 study participants. The aim of this stage is to establish feasibility of successfully completing the initial study CMR within ten days of sepsis presentation without sedation.

At completion of the feasibility phase, (first 5 participants) feasibility of data collection will be evaluated using the following stopping rule: If at least 4 of attempted 5 patient scans provide adequate available data for CMR analysis and can be completed without sedation or delay beyond the 10-day window (due to coordination or deferral due to hemodynamic instability), the study may continue to the completion phase. If fewer than 4 participants are able to complete the cardiac MRI, the study will be paused until any factors that can improve the feasibility may be identified. Data obtained during the feasibility phase will be included in analysis of CMR abnormalities.

Completion Phase

The Completion Phase will comprise approximately 20 participants in order to complete the pilot study to evaluate for abnormalities on CMR.

We estimate the feasibility phase will require up to 6 months to accrue and perform first CMR for the initial 5 patients and the completion phase will require an additional up to 18 months to accrue 15 additional patients who can complete CMR evaluation

Cardiovascular Magnetic Resonance Prognosticators in Pediatric Oncology Patients With Sepsis

Cardiovascular Magnetic Resonance Prognosticators In Pediatric Oncology Patients With Sepsis: A Priority Pilot Study

The proportion of enrolled participants who have evaluable cMRI data within 10 days after onset of sepsis

To estimate the frequency of subacute sepsis-associated cardiac disease, including myocardial inflammation and dysfunction, in the post-acute phase (within 10 days of presentation) of severe sepsis in children with cancer

St. Jude Children's Research Hospital

Neoplasms

Skin and Connective Tissue Diseases

COVID-19

Ganglion Cysts

Synovial Cyst

Cysts

Pneumonia

Pneumonia, Viral

Respiratory Tract Infections

Virus Diseases

Coronavirus Infections

Coronaviridae Infections

Nidovirales Infections

RNA Virus Infections

Mucinoses

Connective Tissue Diseases

The procedure will be done at the bedside in the ICU without interfering with ongoing treatment.

Stellate Ganglion Block

Ali R Rezai, MD

The purpose of this study is to understand if it is safe and useful to perform SGB (Stellate Ganglion Block) in patients who have severe lung injury Acute Respiratory Distress Syndrome (ARDS) due to COVID-19 infection.

Primary Aim:

• To determine safety of stellate ganglion block (SGB) in ARDS

Secondary Aim:

* To determine efficacy of SGB in slowing the progression of ARDS

Stellate Ganglion Block (SGB) for COVID-19 Acute Respiratory Distress Syndrome (ARDS)

Adverse events that can atleast unlikely be attributed to SGB

Change from baseline clinical respiratory/pulmonary function as assessed by change in PF ratio

Change from last imaging data obtained prior to SGB procedure

Change from baseline clinical cardiac function as assessed by improvement in arrhythmia as measured by standard of care ECG ( rate, rhythm and / or any aberrant electro physiological changes)

West Virginia University

Director

Digestive System Diseases

Stomach Neoplasms

Liver Diseases

Pulmonary Atelectasis

Edema

Pleural Effusion

Pneumothorax

Pancreatic Diseases

Pulmonary Edema

Airway Obstruction

Gastrointestinal Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Stomach Diseases

Stomach Cancer

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
ALI/ARDS in Oncologic Pediatric Patients	NCT01304654	Acute Lung Inju... Acute Respirato... Neoplasms		29 Days - 17 Years	Grupo de Apoio ao Adolescente e a Crianca com Cancer
Cardiovascular Magnetic Resonance Prognosticators in Pediatric Oncology Patients With Sepsis	NCT05930418	Acute Respirato... Sepsis Cardiovascular ...	Cardiac MRI	9 Years - 25 Years	St. Jude Children's Research Hospital
ALI/ARDS in Oncologic Pediatric Patients	NCT01304654	Acute Lung Inju... Acute Respirato... Neoplasms		29 Days - 17 Years	Grupo de Apoio ao Adolescente e a Crianca com Cancer
Stellate Ganglion Block (SGB) for COVID-19 Acute Respiratory Distress Syndrome (ARDS)	NCT04402840	Acute Respirato... COVID-19	Stellate Gangli...	18 Years - 80 Years	West Virginia University
Stellate Ganglion Block (SGB) for COVID-19 Acute Respiratory Distress Syndrome (ARDS)	NCT04402840	Acute Respirato... COVID-19	Stellate Gangli...	18 Years - 80 Years	West Virginia University
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
Cardiovascular Magnetic Resonance Prognosticators in Pediatric Oncology Patients With Sepsis	NCT05930418	Acute Respirato... Sepsis Cardiovascular ...	Cardiac MRI	9 Years - 25 Years	St. Jude Children's Research Hospital
Stellate Ganglion Block (SGB) for COVID-19 Acute Respiratory Distress Syndrome (ARDS)	NCT04402840	Acute Respirato... COVID-19	Stellate Gangli...	18 Years - 80 Years	West Virginia University

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