Cardiorespiratory Effect of Respirators in Mild Respiratory Disease

NOTICE OF INTENT TO ISSUE AN ORDER. This is not a request for competitive proposals/quotes. The Centers for Disease Control and Prevention (CDC) hereby announces its intent to issue a sole source order to West Virginia University (WVU), at PO Box 6201, Morgantown, WV 26506 for Cardiorespiratory Effect of Respirators in Mild Respiratory Disease. The NAICS code for this acquisition is 541990- All Other Professional, Scientific, and Technical Services, with a size standard of $19.5 million. ****DRAFT***** SECTION 1 – BACKGROUND Prior to the COVID-19 pandemic, the Centers for Disease Control and Prevention estimated that 20 million US workers use personal protective equipment, which included approximately 3 million users of respiratory protection (OSHA, 2002). Respirators must be used in workplaces in which employees are exposed to hazardous airborne contaminants. When respiratory protection is required employers must have a respirator protection program as specified in OSHA’s Respiratory Protection standard (29 CFR 1910.134[1]). Before wearing a respirator, workers must first be medically evaluated using the mandatory medical questionnaire or an equivalent method. In addition to the mandatory questionnaire, other means of evaluation have been used, such as physical examination, spirometry, and exercise stress testing. Within industrial settings, the causes for worker restrictions for respirator use by physicians have not been well characterized (Pappas et al., 1999). Understanding the relative importance of personal protection in the workplace affects compromised individuals as well as normal healthy workers. According to the Institutes of Medicine report for Preparing for an Influenza Pandemic (National Academies, 2007), in the chapter Moving Forward and Urgency (page 171), an integrated effort is needed to understand the requirements of the worker relative to user comfort while using personal protective equipment (PPE) such as respiratory protective devices (RPDs) and develop technologies to meet those needs. Furthermore, the NIOSH Board of Scientific Counselors received a report, Implementation of the National Academies’ Program Recommendation: NIOSH Personal Protective Technology (PPT) Program (2011) where innovative PPE designs and test method development are needed to improve respirator comfort, fit, and usability. The effects from wearing respiratory protection among healthy workers have been well known. The most significant factors that affect the respirator user are inhaled and exhaled breathing resistance, and additional dead space (Louhevaara, 1984). At levels of submaximal energy expenditure, added inhalation and exhalation resistance may result in hypoventilation, carbon dioxide (CO2) retention, decreased tidal volume and respiratory rate. Almost linear increases in ventilation rate occur with increasing dead space during submaximal exercise. Exhaled breathing resistance affects ventilation more than inhaled breathing resistance. Additional dead space with submaximal exercise causes a near linear increase in ventilation, largely by increasing tidal volume. Physiologic effects from wearing RPDs is affected by the type of respiratory protection. Lower ventilation rate by lower breathing frequency has been observed with air-filtering respirators during submaximal exercise. A small increase in heart rate usually is seen when using a filtering face piece respirator. These ventilation effects affect the wearers ability to tolerate the personal protection, especially if they have pulmonary disease (Martyny, Glazer, and Newman, 2002). Collectively, pulmonary disease may present under one or more of four categories: obstructive pulmonary disease, restrictive pulmonary disease, pulmonary vascular disease, and disorders in ventilatory control . The major limitation in obstructive pulmonary disease is increased airway resistance. Obstructive pulmonary diseases include asthma, chronic obstructive pulmonary disease (COPD), alpha-1 antitrypsin deficiency (AATD), excessive dynamic airway collapse (EDAC), tracheobronchomalacia (TBM), bronchiolitis obliterans, and diffuse idiopathic pulmonary neuroendocrine cell hyperplasia (DIPNECH). COPD is characterized by persistent respiratory symptoms and airflow limitation that is due to airway and/or alveolar abnormalities usually caused by exposure to toxins and influenced by other factors such as abnormal lung development (Vogelmeier, 2021). Cigarette smoking is the most common toxin for COPD. Chronic bronchitis (airway inflammation and scarring) and emphysema (small airways disease and parenchymal damage) are pathological terms associated with COPD. Asthma is an inflammatory disorder causing temporary constriction of the airway. Currently, some have argued for the addition of asthma with other COPDs, as a reversible component of COPD. AATD is a genetic disorder which leads to lung damage, especially with lower-lobe emphysema, sometimes with comorbidities of liver disease and subcutaneous tissue inflammation. EDAC is the collapse and narrowing of the trachea posterior wall membrane by more than 50% while the cartilage remains intact. TBM is the softening of anterior and/or lateral tracheal wall cartilage. Bronchiolitis obliterans is caused by bronchial wall thickening and air trapping. DIPNECH usually occurs in women 45-70 years old, with fixed airway obstruction, chronic cough, and dyspnea. Bronchiectasis is characterized by irreversible airway dilation caused by an infection or injury that further causes debilitating symptoms (chronic cough, purulent sputum, dyspnea, sinusitis, and chronic fatigue). The causes of bronchiectasis are unknown; however, recurring bronchial infections with cystic fibrosis, whooping cough, tuberculosis, and measles occur most often with the obstructive disease. Restrictive pulmonary disease presents in several different diseases: interstitial lung disease that is usually confined to the lung parenchyma and is the largest subgroup of restrictive lung disease; intrapleural disease; and, extrapleural disease. Abnormal lung expansion is the characteristic result from the pathologic process for each disease (Litow et al., 2015). Pneumoconioses such as silicosis, asbestosis, and coal worker’s pneumoconiosis are interstitial lung diseases caused by the inhalation of the element used in its name. Hypersensitivity pneumonitis (extrinsic allergic alveolitis) is described as an allergic immune response to an inhaled antigen (e.g., farmer’s lung and bird fanciers lung). Granulomatous diseases include chronic immune and foreign-body responses that are uncommon and may affect different people with different exposures (e.g., beryllium disease). Diffuse interstitial fibrosis results from a lung injury. Pulmonary vascular disease includes pulmonary hypertension which may be subdivided further into pulmonary arterial hypertension, pulmonary venous hypertension, hypoxia-associated pulmonary hypertension, thromboembolic pulmonary hypertension, and idiopathic pulmonary hypertension sometimes with more than one mechanism. It is characterized by increased pulmonary vascular resistance (progressive obstruction of the lung blood vessels) that further causes right heart failure. Disturbances in ventilatory control include hyperventilation disorders (excessive alveolar ventilation) from chronic metabolic acidosis (e.g., alcohol and aspirin abuse, uncontrolled diabetes, and chronic renal failure) or without an apparent pathology; and, hypoventilation disorders (high carbon dioxide pressures in arterial blood) that occur usually with severe co-morbidities, like COPD and obesity. Hyperventilation disorders are characterized by excessive ventilatory responses to low work rates and hypoventilation disorders are characterized by decreased ventilator responsiveness to conditions such as hypoxia and hypercapnia. World-wide, COPD now is the third leading cause of death (Vogelmeier, et.al., 2021). Silicosis is the most common occupational lung disease in the world (3600-7300 cases in the U.S.) (Litow et.al., 2015). Over decades, the incidence coal worker’s pneumoconiosis was declining but has begun to increase again for reasons unknown. The death rate from chronic respiratory disease in the United States is ranked third, behind heart disease and cancer (NCHS, 2016). SECTION 2 – PURPOSE The purpose of this laboratory-based research pilot project is to evaluate the physiological stresses experienced by men with mild respiratory disease while using commercially available N95 filtering face piece respirators (FFRs), elastomeric air-purifying half masks (EHMRs), and powered air-purifying respirators (PAPRs) at rest and during low- to moderate-intensity exercise on an ergometer (leg only or a combination arm-leg). The specific objective is to determine whether respirator stressors, such as elevated inhalation breathing resistance, have negative effects on exercise cardiac output in mild respiratory disease. The principal target audience for the project includes the wider ANSI Z88 Accredited Standards Committee on Respiratory Protection, the NPPTL Conformity Verification and Standards Development Branch and OSHA. Additional target audience members include workers who are required to wear respiratory protection, licensed health care professionals who are tasked with evaluating the fitness of workers to wear respirators, others involved in respirator research, and respirator manufacturers. Furthermore, findings from this project will be translated to the workplace through collaborative efforts between NIOSH and RPD manufacturers. SECTION 3 – SCOPE OF WORK The objective of this project will determine whether respirator stressors such as elevated inhalation breathing resistance and reduced inhaled oxygen concentration have adverse effects on exercise cardiac output, and thus implications for functional capacity, in persons with mild obstructive respiratory disease (MRD). For this study, the definition of MRD will be based on spirometry during the recruitment of subjects (Stanojevic et al., 2022). This study will evaluate the heart rate, cardiac output, and stroke volume by human subjects (cases with MRD, controls without MRD and smoke cigarettes, and controls without MRD and do not smoke cigarettes) wearing three different respiratory protective devices (RPD) during sitting rest and while exercising with cycle ergometry at low (330 watts) and moderate (660 watts) levels of energy expenditure. Durations will be 5 minutes at each workload, or until one of the termination criteria is met. Findings will be disseminated to the scientific, user, and manufacturer communities and used to support regulations for OSHA 1920.134 guidance. Ultimately, completion of the objectives of this project will result in a significant step toward ensuring that those with cardiorespiratory impairment from mild respiratory disease may be adequately evaluated for safe use of RPDs. Hypotheses are: 1) Noninvasively-measured cardiopulmonary variables (cardiac output, stroke volume) will be adversely impacted during exercise in participants with abnormal spirometry values (ABN) with externally imposed inhalation breathing resistance (CTL + R), as well as with an elastomeric half-mask respirator (EHMR), when compared to a control trial (CTL); 2) Noninvasively-measured cardiopulmonary variables (cardiac output, stroke volume) will be not be significantly different during exercise in ABN with a powered air-purifying respirator (PAPR) when compared to CTL; and, 3) Noninvasively-measured cardiopulmonary variables (cardiac output, stroke volume) will be not be significantly different during exercise in ABN with a N95 filtering face piece respirator (N95) when compared to CTL. Participants with normal spirometry (NORM) and cigarette-smoking participants with normal spirometry (SNORM) will have no differences in cardiopulmonary variables under any condition. The EHMRs and PAPRs will use P100/HEPA filters and will be provided to the contractor in addition to the N95 FFRs. PERIOD OF PERFORMANCE Twelve (12) months CLIN 0001 ***** A determination by the Government not to compete this proposed action will be based on responses to this notice and is solely in the discretion of the Contracting Officer. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. All vendors must be registered in the System for Award Management (SAM) at www.sam.gov , prior to an award of a federal contract. This action is for supplies or services for which the Government intends to solicit and negotiate with only one source under the authority of FAR 13.106-1(b) and 10 U.S.C. 2304(c)(1). Interested persons may identify their interest and capability to respond to the requirement or submit quotations. This is not a request for competitive quotations ; however, the Government will review any/all product, capabilities, and pricing information submitted prior to the closure of this notice. A determination by the government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. Responsible sources that believe they possess the expertise and capabilities identified above are hereby afforded the opportunity to submit to the Contracting Officer by the closing date of this notice, their written capabilities statement and pricing information in the format they choose, not to exceed 10 pages. Please forward, as applicable, any capabilities, product, pricing information (for products, etc.), and/or other pertinent information to Diane J Meeder, Contracting Officer, CDC, via email at [email protected] by June 5, 2023 at 12:00 PM. ET Local.