Indian Guidelines on Nebulization Therapy.

Inhalational therapy, today, happens to be the mainstay of treatment in obstructive airway diseases (OADs), such as asthma, chronic obstructive pulmonary disease (COPD), and is also in the present, used in a variety of other pulmonary and even non-pulmonary disorders. Hand-held inhalation devices may often be difficult to use, particularly for children, elderly, debilitated or distressed patients. Nebulization therapy emerges as a good option in these cases besides being useful in the home care, emergency room and critical care settings. With so many advancements taking place in nebulizer technology; availability of a plethora of drug formulations for its use, and the widening scope of this therapy; medical practitioners, respiratory therapists, and other health care personnel face the challenge of choosing appropriate inhalation devices and drug formulations, besides their rational application and use in different clinical situations. Adequate maintenance of nebulizer equipment including their disinfection and storage are the other relevant issues requiring guidance. Injudicious and improper use of nebulizers and their poor maintenance can sometimes lead to serious health hazards, nosocomial infections, transmission of infection, and other adverse outcomes. Thus, it is imperative to have a proper national guideline on nebulization practices to bridge the knowledge gaps amongst various health care personnel involved in this practice. It will also serve as an educational and scientific resource for healthcare professionals, as well as promote future research by identifying neglected and ignored areas in this field. Such comprehensive guidelines on this subject have not been available in the country and the only available proper international guidelines were released in 1997 which have not been updated for a noticeably long period of over two decades, though many changes and advancements have taken place in this technology in the recent past. Much of nebulization practices in the present may not be evidence-based and even some of these, the way they are currently used, may be ineffective or even harmful. Recognizing the knowledge deficit and paucity of guidelines on the usage of nebulizers in various settings such as inpatient, out-patient, emergency room, critical care, and domiciliary use in India in a wide variety of indications to standardize nebulization practices and to address many other related issues; National College of Chest Physicians (India), commissioned a National task force consisting of eminent experts in the field of Pulmonary Medicine from different backgrounds and different parts of the country to review the available evidence from the medical literature on the scientific principles and clinical practices of nebulization therapy and to formulate evidence-based guidelines on it. The guideline is based on all possible literature that could be explored with the best available evidence and incorporating expert opinions. To support the guideline with high-quality evidence, a systematic search of the electronic databases was performed to identify the relevant studies, position papers, consensus reports, and recommendations published. Rating of the level of the quality of evidence and the strength of recommendation was done using the GRADE system. Six topics were identified, each given to one group of experts comprising of advisors, chairpersons, convenor and members, and such six groups (A-F) were formed and the consensus recommendations of each group was included as a section in the guidelines (Sections I to VI). The topics included were: A. Introduction, basic principles and technical aspects of nebulization, types of equipment, their choice, use, and maintenance B. Nebulization therapy in obstructive airway diseases C. Nebulization therapy in the intensive care unit D. Use of various drugs (other than bronchodilators and inhaled corticosteroids) by nebulized route and miscellaneous uses of nebulization therapy E. Domiciliary/Home/Maintenance nebulization therapy; public & health care workers education, and F. Nebulization therapy in COVID-19 pandemic and in patients of other contagious viral respiratory infections (included later considering the crisis created due to COVID-19 pandemic). Various issues in different sections have been discussed in the form of questions, followed by point-wise evidence statements based on the existing knowledge, and recommendations have been formulated.

Phase 1 clinical trial for intravenous administration of mesenchymal stem cells derived from umbilical cord and placenta in patients with moderate COVID-19 virus pneumonia: results of stage 1 of the study.

OBJECTIVE: Mesenchymal stem cells can serve as a therapeutic option for COVID-19. Their immunomodulatory and anti-inflammatory properties can regulate the exaggerated inflammatory response and promote recovery of lung damage. METHOD: Phase-1, single-centre open-label, prospective clinical trial was conducted to evaluate the safety and efficacy of intravenous administration of mesenchymal stem cells derived from umbilical cord and placenta in moderate COVID-19. The study was done in 2 stages with total 20 patients. Herein, the results of stage 1 including first 10 patients receiving 100 million cells on day 1 and 4 with a follow up of 6 months have been discussed. RESULTS: No adverse events were recorded immediately after the administration of MSCs or on follow up. There was no deterioration observed in clinical, laboratory and radiological parameters. All symptoms of the study group resolved within 10 days. Levels of inflammatory biomarkers such as NLR, CRP, IL6, ferritin and D-dimer improved in all patients after intervention along with improved oxygenation demonstrated by improvement in the SpO2/FiO2 ratio and PaO2/FiO2 ratio. None of the patients progressed to severe stage. 9 out of 10 patients were discharged within 9 days of their admission. Improvements were noted in chest x-ray and chest CT scan scores at day 7 in most patients. No post-covid fibrosis was observed on chest CT 28 days after intervention and Chest X ray after 6 months of the intervention. CONCLUSION: Administration of 100 million mesenchymal stem cells in combination with standard treatment was found to be safe and resulted in prevention of the cytokine storm, halting of the disease progression and acceleration of recovery in moderate COVID-19. This clinical trial has been registered with the Clinical Trial Registry- India (CTRI) as CTRI/2020/08/027043. http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43175.

Comparison in Outcome of Patients with Post TB-Destroyed Lung and COPD Admitted with Respiratory Failure.

INTRODUCTION: The term post TB sequelae is usually used to describe the destructive lung parenchymal changes due to pulmonary tuberculosis, which occur over years, and cause chronic airway obstruction as well as restriction. Furthermore, post TB sequelae and COPD are common causes of acute exacerbation with respiratory failure in Indian setting. AIM OF THE STUDY: To compare the outcome of patients with post TB sequelae and COPD admitted with respiratory failure Methodes: 62 Post TB sequelae and 79 COPD patients admitted in respiratory failure were treated as per standard ICU protocols. Outcome of these patients in these groups were compared with respect to mortality, morbidity and requirement of type ventilatory support. RESULTS: It was observed that duration of stay, morbidity and mortality in these groups was comparable and difference was not statistically significant. CONCLUSION: The presentation and outcome of COPD and Post TB destroyed lung patients is similar, so Post TB Destroyed lung patients should be treated as per COPD guidelines.

Six Minute Walk Test: A Tool for Predicting Mortality in Chronic Pulmonary Diseases.

INTRODUCTION: Six Minute Walk Test (6MWT) is a simple test used to measure exercise capacity in Chronic Pulmonary Diseases (CPDs). Decreased exercise capacity significantly affects the quality of life. The 6MWT is a known tool to measure exercise capacity and quality of life in CPD. However, the role of change in follow up Six Minute Walk Distance (6MWD) in assessing mortality and its correlation with known prognostic factors haven't been tested to the best of our knowledge. AIM: To study the correlation of change in 6MWD with change in spirometry and to study the role of 6MWD in predicting mortality in CPD. SETTINGS AND DESIGN: Prospective cohort study. MATERIALS AND METHODS: A total of 139 CPD patients were grouped into obstructive, restrictive and post Tuberculosis (TB) sequelae. Optimized treatment was given and they were followed up regularly. Spirometry and 6MWT was done at the beginning and after one year. Mean decline in FEV1, FVC was correlated with mean decline in 6MWD. STATISTICAL ANALYSIS: With STATA 13.1 correlation between 6MWT and spirometric values were done using Wilcoxon signed rank test. Predictors of mortality were studied using multivariate analysis. RESULTS: Overall mean decline in 6MWD was 16.07 m/year. There was no correlation between mean change in 6MWD and change in FEV1, FVC, and FEV1/FVC. On multivariate analysis, 6MWD was the better predictor of mortality than FEV1 (p<0.001), FVC (p<0.001). At cut off value of 240 meters, sensitivity and specificity of 6MWT in predicting mortality was 71.05% and 81.94% respectively. CONCLUSION: The 6MWD changes independently and has no correlation with change in spirometry, it is an independent predictor of mortality in CPD.

Cardiac Effect of Interstitial Lung Disease Correlated with Spirometry and Six Minute Walk Test.

INTRODUCTION: The cardiac effect of different pulmonary functions, six minute walk distance, arterial blood gases and saturation in Interstitial Lung Disease (ILD) is not much known. So this study, a tertiary care hospital experience that entails to know the various factors in Pulmonary Hypertension (PH) mentioned above causing PH and their correlation with PH. AIM: To study the correlation of PH in patients with ILD with spirometry and six minute walk test (6MWT). MATERIALS AND METHODS: All consecutive patients with confirmed diagnosis of ILD taken over a period of 1½year in tertiary care hospital. 6MWT and spirometry were performed as per the American Thoracic Guidelines. Percent predicted 6 minute walk distance was calculated using Enright et al., and Indian reference equation. PH was diagnosed using 2-D echo. The spirometry variables and 6MWT were then correlated with the mean pulmonary artery pressure. RESULTS: There were 75 patients. About 66.66 % had PH on 2-D echo. The mean% predicted six minute walk distance as per the Indian reference equation, pre- and post- exercise PaO2 as well as desaturation had a significant correlation with PH. Spirometry variables Forced Expiratory Volume in First Second (FEV1) and Forced Vital Capacity (FVC) did not correlate with PH. CONCLUSION: Thus, the 6MWT correlated significantly with PH while spirometry did not.

Clinical profile, etiology, and management of hydropneumothorax: An Indian experience.

INTRODUCTION: Hydropneumothorax is an abnormal presence of air and fluid in the pleural space. Even though the knowledge of hydro-pneumothorax dates back to the days of ancient Greece, not many national or international literatures are documented. AIM: To study clinical presentation, etiological diagnosis, and management of the patients of hydropneumothorax. MATERIALS AND METHODS: Patients admitted in a tertiary care hospital with diagnosis of hydropneumothorax between 2012 and 2014 were prospectively studied. Detailed history and clinical examination were recorded. Blood, pleural fluid, sputum investigations, and computed tomography (CT) thorax (if necessary) were done. Intercostal drainage (ICD) tube was inserted and patients were followed up till 3 months. RESULTS: Fifty-seven patients were studied. Breathlessness, anorexia, weight loss, and cough were the most common symptoms. Tachypnea was present in 68.4% patients. Mean PaO2 was 71.7 mm of Hg (standard deviation ±12.4). Hypoxemia was present in 35 patients (61.4%). All patients had exudative effusion. Etiological diagnosis was possible in 35 patients by initial work-up and 22 required CT thorax for arriving at a diagnosis. Tuberculosis (TB) was etiology in 80.7% patients, acute bacterial infection in 14%, malignancy in 3.5%, and obstructive airway disease in 1.8%. All patients required ICD tube insertion. ICD was required for 24.8 days (±13.1). CONCLUSION: Most patients presented with symptoms and signs of cardiorespiratory distress along with cough, anorexia, and weight loss. Extensive pleural fluid analysis is essential in establishing etiological diagnosis. TB is the most common etiology. ICD for long duration with antimicrobial chemotherapy is the management.

Effect of Coronary Artery Bypass Grafting Surgery on Pulmonary Function Tests and Arterial Blood Gases.

BACKGROUND AND OBJECTIVE: Pulmonary dysfunction after open heart surgery is an important cause of post-operative morbidity. To evaluate effect of coronary artery bypass grafting (CABG) surgery on pulmonary functions and arterial blood gases (ABGs). METHODS: A prospective study was conducted at a pulmonary unit of a tertiary care public hospital. Of the 50, patients enrolled, 42 patients completed the study. Spirometry was performed one week pre-operatively and within four to five weeks post-operatively. Arterial blood gas samples were also collected just before spirometry. The pre- and post-operative data were compared. RESULTS: There was significant reduction in forced vital capacity (FVC) and forced expiratory volume in one second (FEV1) by 13.8% and 13.1%, respectively within five weeks of surgery. After surgery mean maximum voluntary ventilation (MVV) showed a significant decrease of 7.6%. Post-operatively, the mean pH decreased significantly by 0.1% and the mean partial pressure of oxygen (PaO2) and oxygen saturation SpO2-showed significant decrease of 10.1% and 2.4%, respectively. CONCLUSION: Coronary artery bypass grafting has an adverse impact on lung functions and ABGs.

Correlation between Six Minute Walk Test and Spirometry in Chronic Pulmonary Disease.

INTRODUCTION: Six minute walk test (6MWT), is an exercise test, used as a clinical indicator of the functional capacity, in patients with cardiopulmonary diseases. The present study assessed the correlation of six minute walk test with pulmonary function variables, in patients with chronic pulmonary diseases, in local population. AIMS & OBJECTIVES: The objectives were to study correlation of different spirometry variables with variables of six minute walk test like percent predicted 6 minute walk distance (% Predicted 6MWD) as per Enright et al., formula and Indian reference equation, pre and post exercise pO2 and pCO2 and exercise desaturation. MATERIALS AND METHODS: All consecutive patients with confirmed diagnosis of chronic pulmonary diseases were included from January 2013 to June 2014 in tertiary care institute. 6MWT was performed as per the ATS guidelines. Among 130 patients 108 were also subjected to arterial blood gases pre and post test. Spirometry was performed as per ATS guidelines. Percent (%) predicted 6MWD was calculated. Correlation between spirometry and 6MWT was assessed. RESULTS: One hundred and thirty patients with chronic pulmonary disease were taken. Out of them there was 102 patients with obstructive airway disease and 58 patients with interstitial lung disease. FEV1 significantly correlated with %predicted 6MWD &; with basal pO2 and pCO2 and with post exercise pCO2 and pO2. FVC also correlated with %predicted 6MWD, with basal pO2 and pCO2 and post exercise pO2. FEV1/FVC correlated only with post exercise pCO2 while MVV correlated with %predicted 6MWD and only basal pCO2. Exercise desaturation correlated only with FVC. Percent predicted 6MWD also correlated with basal pO2 & post exercise pO2. CONCLUSION: Thus significant correlation found between 6MWT & spirometry variables (FEV1, FVC, MVV & FEV1/FVC).

Comparison of the efficacy of ciclesonide 160 microg QD and budesonide 200 microg BID in adults with persistent asthma: a phase III, randomized, double-dummy, open-label study.

OBJECTIVE: The efficacy of ciclesonide 160 mug QD (given either in the morning or evening) was compared with budesonide 200 mug BID in adults with stable asthma that was pretreated with inhaled corticosteroids. METHODS: This was a randomized, 3-arm, parallel-group study comparing ciclesonide (given in a double-blind, double-dummy regimen) with open-label budesonide. After 2 to 2.5 weeks, during which patients were treated with budesonide 200 microg BID, patients (n = 405) were randomly assigned to receive ciclesonide 160 microg QD AM or 160 microg QD pm, or budesonide 200 microg BID (all administered by metered-dose inhaler) for 12 weeks. All patients received 2 puffs of medication (or placebo) in the morning and evening. The primary efficacy variable was the difference in spirometric forced expiratory volume in 1 second (FEV(1) in liters) from randomization to study end. Secondary efficacy end points were forced vital capacity, peak expiratory flow by spirometry, and diary assessments of peak expiratory flow, asthma symptoms, and rescue medication use. Adverse events were assessed by patient report, investigator observation, physical examination, and laboratory testing; events were classified as mild, moderate, or severe. RESULTS: Baseline demographic characteristics with regard to sex, age, weight, smoking status, baseline medication use, and FEV(1) were balanced among the treatment groups. Over the course of treatment, both ciclesonide and budesonide maintained FEV(1) compared with baseline. Both ciclesonide regimens were as effective as budesonide 200 microg BID in maintaining FEV(1) during the treatment period versus baseline (ciclesonide 160 microg QD am: 95% CI, -0.120 to 0.045 vs budesonide; P = NS; ciclesonide 160 microg QD pm: 95% CI, -0.061 to 0.105 vs budesonide; P = NS). Ciclesonide 160 microg QD (morning or evening) was comparable with budesonide 200 microg BID for maintaining pulmonary function, asthma symptom scores, and rescue medication use. The incidence of adverse events was not significantly different among the treatment groups, and most adverse events were not related to study medication. CONCLUSIONS: In this study, ciclesonide 160 microg QDwas as effective as budesonide 200 microg BID (400 microg total daily dose) in these adults with persistent asthma. Both treatments were well tolerated.