Exposure measurements taken in ORs during the clinical administration of inhaled anesthetics indicate that waste gases can escape into the room air from various components of the anesthesia delivery system. Potential leak sources include tank valves, high- and low-pressure machine connections; connections in the breathing circuit, defects in rubber and plastic tubing, hoses, reservoir bags, and ventilator bellows, and the Y-connector. In addition, selected anesthesia techniques and improper practices such as leaving gas flow control valves open and vaporizers on after use, spillage of liquid inhaled anesthetics, and poorly fitting face masks or improperly inflated tracheal tube and laryngeal mask airway cuffs also can contribute to the escape of waste anesthetic gases into the OR atmosphere.
This study investigated the in vivo pulmonary toxicity of inhaled multi-walled carbon nanotubes (MWCNT). Mice-inhaled aerosolized MWCNT (10 mg/m³, 5 h/day) for 2, 4, 8 or 12 days. MWCNT lung burden was linearly related to exposure duration. MWCNT-induced pulmonary inflammation was assessed by determining whole lung lavage (WLL) polymorphonuclear leukocytes (PMN). Lung cytotoxicity was assessed by WLL fluid LDH activities. WLL fluid albumin concentrations were determined as a marker of alveolar air-blood barrier integrity. These parameters significantly increased in MWCNT-exposed mice versus controls and were dose-dependent. Histopathologic alterations identified in the lung included (1) bronciolocentric inflammation, (2) bronchiolar epithelial hyperplasia and hypertrophy, (3) fibrosis, (4) vascular changes and (5) rare pleural penetration. MWCNT translocated to the lymph node where the deep paracortex was expanded after 8 or 12 days. Acute inhalation of MWCNT induced dose-dependent pulmonary inflammation and damage with rapid development of pulmonary fibrosis, and also demonstrated that MWCNT can reach the pleura after inhalation exposure.
BREO ELLIPTA for the treatment of asthma was studied in 18 double-blind, parallel-group, controlled trials (11 with placebo) of 4 to 76 weeks' duration, which enrolled 9,969 subjects with asthma. BREO ELLIPTA 100/25 was studied in 2,369 subjects and BREO ELLIPTA 200/25 was studied in 956 subjects. While subjects aged 12 to 17 years were included in these trials, BREO ELLIPTA is not approved for use in this age group [see Use in Specific Populations ]. The safety data described below are based on two 12-week efficacy trials, one 24-week efficacy trial, and two long-term trials.