Neoplasms

Digestive System Diseases

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Infections

Wounds and Injuries

Rare Diseases

Esophageal Neoplasms

Carcinoma

Adenocarcinoma

Respiratory Insufficiency

Carcinoma, Squamous Cell

Fibrosis

Pulmonary Fibrosis

Pneumonia

Radiation Pneumonitis

Radiation Fibrosis Syndrome

Syndrome

Communicable Diseases

Respiratory Tract Infections

Lung Diseases

Respiratory Tract Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Respiration Disorders

Lung Diseases, Interstitial

Lung Injury

Radiation Injuries

Esophageal Cancer

FEV1, FVC and DLCO will be assessed at baseline and one month post induction therapy. Radiation induced lung injury (RILI EORTC grade≥2), CCI, Clavien-Dindo, and pulmonary complications will be monitored. Changes in pulmonary function will be compared with cardiorespiratory symptoms and HR-QL among disease-free survivors.

Esophagectomy

Although recent global trends indicate reduced postoperative mortality after esophagectomy, major morbidity, in particular pulmonary, remains high, with considerable health and economic costs. In a recent modern international collaborative series of 2704 patients from high-volume centers, with an approximate equal mix of open and minimally invasive approaches, respiratory complications were evident in 28% of patients, pneumonia in 15%, and respiratory failure in 7%.1 In other series, respiratory failure is reported in up to 15% of patients and is the most common cause of mortality. Prediction of risk and prevention of respiratory morbidity is therefore of considerable importance, and in this context baseline assessment of respiratory physiology compliments clinical assessment, history and enhanced recovery pathways representing key elements of current patient management.

In this study, which will include all prospective patients with locally advanced esophageal cancer treated at a National Center, pulmonary function will be systematically measured before and after neoadjuvant therapy. The investigators seek to evaluate the incidence of radiation induced lung injury (RILI), as well as subclinical changes in pulmonary physiology that may be linked to postoperative complications, and quality-of-life in survivorship, and to compare cohorts who received radiation therapy or chemotherapy alone, preoperatively.

Neoadjuvant Therapy for Esophageal Cancer and Cardiopulmonary Physiology

Neoadjuvant Therapy for Locally Advanced Esophageal Cancer: Impact on Cardiopulmonary Physiology, Short- and Long-term Morbidity

Changes in FEV1 (forced expiratory volume in one second, litres), both as a raw value, and as percentage of predicted values normalized for ethnicity, sex, age and height according to Global Lung Function Initiative algorithms will be determined.

Changes in FVC (forced vital capacity, litres), both as a raw value, and as percentage of predicted values normalized for ethnicity, sex, age and height according to Global Lung Function Initiative algorithms will be determined.

Changes in DLCO (pulmonary diffusion capacity for carbon monoxide, mmol·min.-1.kPa. -1), both as a raw value, and as percentage of predicted values normalized for ethnicity, sex, age and height according to Global Lung Function Initiative algorithms will be determined.

Incidence of postoperative pulmonary morbidity, defined according to ECCG guidelines, will be compared after neoadjuvant chemotherapy versus chemoradiation.

"Global health" HR-QL scores at one year postoperatively among disease-free patients will be compared between neoadjuvant chemotherapy and chemoradiation cohorts

Disease-free survival will be compared between neoadjuvant chemotherapy and chemoradiation groups using Kaplan-Meier methods, as well as multivariable Cox proportional hazards regression models adjusting for known prognostic factors.

St. James's Hospital, Ireland

Surgical Research Fellow

Blood and Lymph Conditions

Hematologic Neoplasms

Hematologic Diseases

Acute Graft Versus Host Disease

This patient groups will receive only routine oxygen therapy. Routine oxygen therapy involves administering low-to-medium oxygen flows through a nasal cannula or mask to achieve SpO2≥95%.

This patients group will receive high flow oxygen therapy. High flow nasal oxygen therapy is a focus of growing attention as an alternative to standard oxygen therapy. By providing warmed and humidified gas, it allows the delivery of higher flow rates \[of up to 60 L/min\] via nasal cannula devices, with fraction of inspired oxygen(FiO2) values of nearly 100%.

High-flow nasal oxygen \[HFNO\] therapy is a focus of growing attention as an alternative to standard oxygen therapy. By providing warmed and humidified gas, HFNO allows the delivery of higher flow rates \[of up to 60 L/min\] via nasal cannula devices, with fraction of inspired oxygen(FiO2) values of nearly 100%.

High flow oxygen therapy

Effectiveness of high flow oxygen therapy in patients with hematologic malignancy acute hypoxemic respiratory failure

Acute respiratory failure (ARF) is the leading reason for ICU admission in immunocompromised patients. Usual oxygen therapy involves administering low-to-medium oxygen flows through a nasal cannula or mask to achieve SpO2≥95%.

High-flow nasal oxygen \[HFNO\] therapy is a focus of growing attention as an alternative to standard oxygen therapy. By providing warmed and humidified gas, HFNO allows the delivery of higher flow rates \[of up to 60 L/min\] via nasal cannula devices, with fraction of inspired oxygen (FiO2) values of nearly 100%. Physiological benefits of HFNO consist of higher and constant FiO2 values, decreased work of breathing, nasopharyngeal washout leading to improved breathing-effort efficiency, and higher positive airway pressures associated with better lung recruitment.

Clinical consequences of these physiological benefits include alleviation of dyspnea and discomfort, decreases in tachypnea and signs of respiratory distress, a diminished need for intubation in patients with severe hypoxemia, and decreased mortality in unselected patients with acute hypoxemic respiratory failure However, although preliminary data establish the feasibility and safety of this technique, HFNO has never been properly evaluated in immunocompromised patients.

Thus, this project aims at demonstrating that HFNO is superior to low/medium-flow (standard) oxygen, minimizing the need for endotracheal intubation

Effectiveness of High Flow Oxygen Therapy in Patients With Hematologic Malignancy Acute Hypoxemic Respiratory Failure

Patient comfort with Visual Analogue Scale (VAS) score

Kursat Gundogan

Associate professor

Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

Nervous System Diseases

Behaviors and Mental Disorders

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Heart and Blood Diseases

Immune System Diseases

Diabetes Mellitus

Dementia

Death

Pulmonary Disease, Chronic Obstructive

Kidney Failure, Chronic

Renal Insufficiency

Heart Failure

Stroke

Coronary Artery Disease

Myocardial Ischemia

Liver Failure

Hepatic Insufficiency

Acquired Immunodeficiency Syndrome

HIV Infections

Immunologic Deficiency Syndromes

Arteriosclerosis

Failure to Thrive

Coronary Disease

Ischemia

Heart Diseases

Brain Diseases

Central Nervous System Diseases

Kidney Diseases

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Chronic Disease

Disease Attributes

Lung Diseases, Obstructive

Blood-Borne Infections

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

Lentivirus Infections

Retroviridae Infections

Virus Diseases

RNA Virus Infections

Slow Virus Diseases

Genital Diseases

Liver Diseases

Cerebrovascular Disorders

Vascular Diseases

Arterial Occlusive Diseases

Renal Insufficiency, Chronic

Chronic Graft Versus Host Disease

Multidisciplinary palliative care team met with patient

Ingrid M Venohr, RN, PhD

Douglas A Conner, PhD

Marcia Liberson, MSW,MPH

Palliative care is believed to improve care of patients with life-limiting illnesses. This study evaluated the impact of a multi-center randomized trial of a palliative care team intervention on the quality and cost of care of hospitalized patients. Study subjects were randomized to intervention or usual care. At study end, patients receiving the palliative care intervention reported greater patient satisfaction with their care. Intervention patients also had significantly fewer ICU admissions and lower total costs for care 6 months past their hospitalization. Intervention patients completed more advance directives and had longer hospice stays.

The Inpatient Palliative Care Service (IPCS) was implemented at three Kaiser-Permanente sites: Colorado, Portland and San Francisco. The service consisted of a physician, nurse, social worker, and spiritual counselor who worked with the study subjects randomized to receive the intervention. The intervention included symptom control, emotional and spiritual support, advance care and post-discharge care planning, There were no differences in symptom control or emotional support but IPCS patient reported better spiritual support compared to usual care patients. IPCS patients also reported greater satisfaction with their hospital care experience and better communication with their providers. Both IPCS and usual care patients reported improved quality of life during their enrollment hospital stay. IPCS patients completed more advance directives. IPCS patients had more home health visits than usual care patients but significantly fewer ICU admissions. IPCS patients had significantly lower hospital costs and higher pharmacy costs, than the usual care patients. IPCS patients had significantly lower (p= .001) total health services costs (a cost savings of $64.90 per patient per day) compared to usual care patients. This translated to an average total cost savings of $3,185 per enrolled patient. IPCS patients had a significantly longer average hospice length of stay. There were no differences between IPC and usual care patients in the proportion admitted to hospice, time to hospice admission, the average length of survival, or proportion of those who survived to 6 months.

Conclusion: IPCS resulted in better spiritual support, a better hospital care experience, better communication with their providers, increased completion of advance directives, fewer ICU admissions, longer hospice stays and reduced overall health care costs.

Multidisciplinary Inpatient Palliative Care Intervention

A Multi-Site Replication of an Inpatient Palliative Care Program

Garfield Memorial Fund

Kaiser Permanente

Composed of HCT patients with respiratory failure requiring intubation and mechanical ventilation.

Composed of oncology patients (solid tumor or leukemia patients) who have not undergone HCT and who have respiratory failure requiring intubation and mechanical ventilation.

Composed of chimeric antigen T-cell receptor infusion recipients who have respiratory failure requiring intubation and mechanical ventilation.

Tim Flerlage, MD

This study is being done because researchers want to learn more about genes that control the immune response in the participant's lungs and blood when the participant have lung disease leading to respiratory failure.

Primary Objective

To evaluate the feasibility of performing single cell gene expression analyses on tracheal aspirates from immunocompromised pediatric patients with immune compromising conditions, including HCT recipients.

Secondary Objectives

* To assess whether cell composition and activation states in longitudinally obtained tracheal aspirate and blood samples are able to distinguish unique immunopathology for each of the early post-HCT lung diseases.
* To assess whether cell composition and activation states in longitudinally obtained tracheal aspirate and blood samples are different between two immunodeficient patient populations (alloHCT vs non alloHCT) with lung disease and respiratory failure.
* To test the hypothesis that allogeneic T cell responses are implicated in the pathogenesis of early post-HCT lung diseases.

Exploratory Objectives

To correlate immune cell signaling in the lower respiratory tract and blood of patients with early post-HCT lung diseases with the presence or absence of pathogenic microbes at each site.

To explore HLA testing in Tracheal Aspirates in samples where enough cells are present.

This study involves a Tracheal aspirate, Bronchoalveolar lavage (BAL), and blood samples. The tracheal aspirates and blood samples will be obtained within 24 hours of intubation, then twice more every 3 -4 days, and then once a week until the patient is extubated. If the primary treatment team performs bronchoscopy with BAL, then an aliquot of residual BAL fluid will be obtained.

Immunologic Features of Respiratory Failure in Pediatric Hematopoietic Cell Transplantation (HCT) Recipients and Pediatric Oncology Patients

Feasibility is a qualitative binary outcome (Yes and No), based on the success of recovery of more than 100,000 live cells from a tracheal aspirate and blood sample from five of the first ten allo HCT patients enrolled on the study protocol.

This is a qualitative binary outcome (Yes/No) by applying single cell gene expression analyses to cells from tracheal aspirates and blood of patients with post-HCT lung diseases. With visualization techniques, a call of success (Yes/No) will be made.

This is a qualitative binary outcome (different vs not different) obtained from visualization.

This is a qualitative binary endpoint assessed by visualization.

St. Jude Children's Research Hospital

Acute Coronary Syndrome

Myocardial Infarction

Infarction

Lung Neoplasms

Angina Pectoris

Angina, Unstable

Arrhythmias, Cardiac

Thromboembolism

Airway Obstruction

Necrosis

Respiratory Tract Neoplasms

Thoracic Neoplasms

Pain

Chest Pain

Neurologic Manifestations

Thrombosis

Embolism

Embolism and Thrombosis

Pharmaceutical Solutions

All Drugs and Chemicals

Normal saline sprayed into stent/airway tubes then suctioned out through bronchoscope.

Sodium bicarbonate sprayed into stent/airway tubes then suctioned out through bronchoscope.

Normal saline administered in stent/airway tubes under direct visualization via the bronchoscope.

Normal Saline

4.2% bicarbonate solution mixed with equal volume of sterile water administered into stent/airway tubes under direct visualization via the bronchoscope.

Sodium Bicarbonate

Carlos A. Jimenez, MD

The goal of this clinical research study is to compare the effects of sodium bicarbonate to normal saline when used for clearing mucus blockage in patients with airway stents.

Study Agents:

Sodium bicarbonate is also called baking soda. In this study it will be mixed with water.

Normal saline is a salt water solution.

Study Groups:

If you agree to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. The study doctor will use either sodium bicarbonate or normal saline during your bronchoscopy to clear mucus from your stent:

* If you are in Group 1, the study doctor will use sodium bicarbonate. The amount of sodium bicarbonate in the solution will be the same for all patients in Group 1.
* If you are in Group 2, the study doctor will use normal saline.

You will have an equal chance of being assigned to either group. Neither you nor the study staff can choose the group you will be in, and neither you nor your doctor will know if you are receiving sodium bicarbonate or normal saline. However, if needed for your safety, the study staff will be able to find out what you are receiving.

If you have more than 1 stent, only 1 of your stents will be checked for clearance of mucus in this study. However, all stents will be cleared of mucus if needed.

As part of your standard of care, you will have photographs and videos taken before and after your bronchoscopy. You will sign a separate consent form for your bronchoscopy. Your complete medical history will also be recorded.

For the bronchoscopy, you will be given drugs to help you relax, and then a local anesthetic will be sprayed into your nose and throat to numb those areas. A slim, flexible tube with a light will be placed through your nose or mouth and into your airway tubes.

If you are in Group 1, a small amount of sodium bicarbonate will be sprayed into your stent/airway tubes and then suctioned out through the bronchoscope.

If you are in Group 2, a small amount of normal saline will be sprayed into your stent/airway tubes and then suctioned out through the bronchoscope.

Next, 3 study doctors will check how well the mucus in your stent was cleared. If the study doctors think not enough mucus has been cleared from your stent, you will "crossover" into the other study group and receive the other agent to clear your mucus.

Length of Study:

Your participation on the study will be over after you have completed the follow-up visits.

Follow-Up:

At about 7 days, and then again 30 days after your bronchoscopy, you will come to the clinic for a follow-up visit. The following procedures will be performed:

* You will have a physical exam, including measurement of your vital signs (blood pressure, heart rate, temperature, and breathing rate).
* You will also be asked about any side effects you may be having.

This is an investigational study. Normal saline and sodium bicarbonate are agents used in bronchoscopies performed in patients with airway stents as standard of care. The comparison of sodium bicarbonate to normal saline to clear mucus from airway stents is considered investigational.

Up to 40 patients will take part in this study. All will be enrolled at MD Anderson.

Clearance Of Mucus In Stents (COMIS)

Response/efficacy of sodium bicarbonate versus normal saline in airway stents graded using scale. Percentage of obstruction resolution (relative to initial stent lumen obstruction by mucus): Good response 51-75% clearance; and Excellent 76 - 100% clearance. The Mantel-Haenszel chi-square test stratified by degree of lumen obstruction at study enrollment used to compare response (good or excellent obstruction resolution) rates between treatment arms.

M.D. Anderson Cancer Center

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Neoadjuvant Therapy for Esophageal Cancer and Cardiopulmonary Physiology	NCT03462524	Esophageal Canc... Radiation Pneum... Pulmonary Fibro... Respiratory Fai... Pneumonia Surgery Chemotherapy Ef... Radiation Fibro... Radiation Toxic... Adenocarcinoma Squamous Cell C...	Esophagectomy	18 Years -	St. James's Hospital, Ireland
Effectiveness of High Flow Oxygen Therapy in Patients With Hematologic Malignancy Acute Hypoxemic Respiratory Failure	NCT03133520	Acute Hypoxemic... Hematologic Mal...	High flow oxyge...	18 Years -	TC Erciyes University
Multidisciplinary Inpatient Palliative Care Intervention	NCT00325611	Cerebrovascular... Cancer Coronary Arteri... Heart Failure, ... Diabetes Mellit... Acquired Immuno... Failure to Thri... Pulmonary Disea... Dementia Kidney Failure,... Pneumonia Liver Failure Renal Failure Respiratory Fai... Stroke	Multidisciplina...	18 Years -	Kaiser Permanente
Immunologic Features of Respiratory Failure in Pediatric Hematopoietic Cell Transplantation (HCT) Recipients and Pediatric Oncology Patients	NCT04355780	Respiratory Fai... Respiratory Dis...		- 21 Years	St. Jude Children's Research Hospital
Clearance Of Mucus In Stents (COMIS)	NCT01370278	Lung Neoplasms Respiratory Fai... Pneumonia Acute Coronary ... Unstable Angina Myocardial Infa... Cardiac Arrhyth... Thromboembolic ...	Normal Saline Sodium Bicarbon...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for respiratory failure