Bioequivalence Between Albuterol Sulfate Inhalation Aerosol 108 mcg Per Actuation and Proair HFA...
HealthyThis study was designed to assess the bioequivalence between the test products (Albuterol Sulfate Inhalation Aerosol 108 mcg Per Actuation) and the reference products (Proair HFA [Albuterol Sulfate] Inhalation Aerosol 90 mcg Per Actuation) in healthy volunteers under fasting conditions. The test product was considered bioequivalent to the reference product if the T/R ln-transformed AUC(0-t), AUC(0-inf), and Cmax were within 80.00-125.00% of those of the reference.
The Effect of Allergen Inhalation on Sputum Myeloid and Plasmacytoid Dendritic Cells in Mild Atopic...
AsthmaSummary: A picture is emerging of dendritic cells migrating through the blood to the airways following allergen inhalation in atopic asthmatics. Although the Koh and McCarthy articles present novel findings, both do not provide a comprehensive view of sputum DCs following allergen challenge. Therefore, the proposed study will examine the kinetics of mDCs and pDCs in the induced sputum of atopic asthmatics following inhalation of allergen. Hypothesis: Following allergen challenge, sputum myeloid and plasmacytoid DCs will migrate into the airway lumen in atopic asthmatics during the timeframe of the late asthmatic response. Objective: The objective of this study is to examine the kinetics of dendritic cells in induced sputum following allergen challenge in atopic asthmatic subjects.
A Bioequivalence Study Between Fluticasone Propionate 100 mcg and Salmeterol Xinafoate 50 mcg Inhalation...
BioequivalenceBioequivalence study between two inhaler products of fixed dose combination of fluticasone propionate and salmeterol xinafoate inhalation powder
Impact of Neck Inspiratory Muscle Activation During Sleep in ICU Patients After a COVID 19 ARDS...
ARDSCOVID-19Most patients in intensive care units (ICUs) experience severe sleep disruption. Sleep disruption and sleep alteration may have an influence on the ability to breathe spontaneously. But, the cause of altered sleep remains unknown. Previous studies have shown that decreasing nocturnal respiratory muscle activity through mechanical ventilation might improve sleep quality. Nocturnal respiratory muscle activity may be one of the potential factor which contribute to alter sleep in the ICU. Therefore, the aim of this study is to analyse the presence of NIM activation during the night and it's consequence in an ICU population with the same pathology (COVID 19 ARDS).
A Bioequivalence Study Between Fluticasone Propionate 250 mcg and Salmeterol Xinafoate 50 mcg Inhalation...
BioequivalenceBioequivalence study between two inhaler products of fixed dose combination of fluticasone propionate and salmeterol xinafoate inhalation powder
A Pilot Bioequivalence Study Between Fluticasone Propionate 500 mcg and Salmeterol Xinafoate 50...
Bioequivalenceioequivalence study between two inhaler products of fixed dose combination of fluticasone propionate and salmeterol xinafoate inhalation powder
Automated Closed Loop Propofol Anaesthesia Versus Desflurane Inhalation Anaesthesia In Bariatric...
Anesthesia; Bariatric SurgeryComplete recovery from anaesthesia is absolutely desirable in the obese patients to avoid postoperative airway, oxygen ventilation or sleep apnea related complications. Over the years, Desflurane has emerged as the anaesthetic agent of choice for maintenance of anaesthesia in obese patients for its efficient elimination profile and ability to facilitate early recovery from anaesthesia. Alternatively, Propofol is a commonly used intravenous anesthetic agent administered as a part of total intravenous anesthesia (TIVA) regimen. However, it is a lipid soluble drug and there are concerns that it may accumulate in obese patients due to their increased proportion of body fat Therefore, Propofol TIVA is likely to result in a prolonged duration of action and consequently, delayed emergence from anaesthesia and a protracted recovery time. A recent advance in the delivery of Propofol to the patient is the development of computer-controlled anesthesia delivery systems. These devices deliver Propofol based on feedback from patient's frontal cortex electrical activity as determined by monitoring bispectral index (BIS). Evaluation of anesthesia delivery by these systems has shown that Propofol and maintain depth of anesthesia with far more precision as compared to manual/simple infusion administration. This, in turn, holds promise that recovery from Propofol anaesthesia can also be favourable in the obese patients. An indigenously developed computer-controlled anesthesia delivery sytem is the closed loop anaesthesia delivery system (CLADS), which has been extensively evaluated in patients belonging to different surgical settings. The evidence generated with Propofol anaesthesia delivered by CLADS has shown significant improvement in recovery outcome.The performance of CLADS has not yet been evaluated in obese surgical patients. We hypothesise that in the obese patients undergoing bariatric surgery, automated delivery of Propofol using CLADS would allow precision control of anaesthesia depth, intra-operative haemodynamics, and rapid recovery from anaesthesia. We plan to conduct a randomised controlled investigation to compare patient recovery profile following Desflurane anaesthesia versus CLADS empowered Propofol anaesthesia.
Work of Breathing Assessment During Weaning From Mechanical Ventilation
Mechanical VentilationIntroduction In patients assisted by mechanical ventilation, the Work Of Breathing (WOB) is shared between the patient and the ventilator. During weaning from mechanical ventilation, the WOB performed by the patient must be adequate and efficient to sustain spontaneous ventilation after extubation. The monitoring of WOB during weaning might allow a better management of the weaning process. Esophageal pressure (PES) is the reference technique to measure WOB but alternate tools have been proposed. The main hypothesis is that Indirect Calorimetry (IC) is valid to track the changes in energy expenditure due to the changes in WOB in mechanically ventilated children during weaning from mechanical ventilation. The primary objective of this study is to assess the validity of IC method for the WOB assessment when compared to PES measurement and Electrical Activity of the diaphragm (EAdi) during a spontaneous breathing trial (SBT) in continuous positive airway pressure, which is a routine extubation readiness test which generally induces an increase in WOB. Methods This is a prospective single center study. All intubated and mechanically ventilated children >1 months and <18 years old, hospitalized in the pediatric intensive care unit will be eligible. Simultaneous recordings of Energy Expenditure, PES and EAdi will be performed during 3 steps: before, during and after the SBT. Then outcome of patients will be collected. The investigators plan to study a sample of 15 patients to be representative. Relevance to the importance of child health in Canada The investigators expect that the IC-based less invasive method will provide an accurate estimation of WOB assessment. Once this tool is validated, the interest of IC to (i) early detect an increase in WOB during mechanical ventilation in children, (ii) to assess the ability to extubate them and (iii) to optimize nutritional support will be assessed in future studies.
The Gas Mask: the Effects on Respiration!
Work of BreathingBackground: The gas mask is used to protect military and non-military subjects exposed to respiratory hazards (CBRN agents). The aim of the study was to evaluate the impact of the gas mask on respiratory patterns and indexes of the respiratory effort. Methods: We are completing our study with 14 healthy subjects to evaluate breathing patterns, index of respiratory efforts and blood gases. Seven conditions have been tested in a randomized order: at rest, during effort (on a tread mill, standardized at 7 METs for all subjects) and during induced hypoxemia with and without a mask (C4, Airboss Defence, Bromont, Canada). Airway pressure, inspiratory and expiratory flows were measured. An esophageal catheter was introduced at the beginning of the study to measure esophageal pressure (Peso) and calculate indexes of respiratory effort (PTPeso, WOB). SpO2 was continuously measured and capillary blood bases were drawn at the end of each condition. Each condition lasted 10 minutes, data of the last 2 minutes at a steady state were considered for analyses. Results: The preliminary analyses based on 10 subjects are presented here. Comparing the wearing of the gas mask and without, most of the respiratory index increased in the tested conditions (at rest, during induced hypoxemia and during effort). At rest, in 8 out of 10 healthy subject the indexes of effort were higher with the gas mask, a statistical trend was observed with the WOB (0.22±0.13 vs. 0.28±0.10 J/cycle; p = 0.059), the PTPes (101±35 vs. 122±47 cmH2O*s; p=0.21) and SwingPeso (4.4±2.0 vs. 5.3±2.0 cmH2O; p=0.13). During the effort, the respiratory index increased (WOB 4.0±2.6 vs. 5.6±3.2; p=0.10; PTPeso 406±211 vs. 606±65; p=0.04; SwingPeso 14.8±8.1 vs. 21.8±9.0; p=0.13). There was no difference for the breathing pattern and arterial blood gases data with and without mask. Data for induced hypoxemia are under analysis. We measured on bench the inspiratory and expiratory resistances of the tested gas mask (C4: inspiratory resistances = 3.2 cmH2O at 1 L/sec; expiratory resistances = 0.9 cmH2O at 1 L/sec). This may explain in part the increased work of breathing with masks. Conclusions: This study demonstrated an increase of the indexes of respiratory effort during an exercise with the gas mask. This study is the first to directly assess the indexes of efforts with esophageal pressure in this situation. Our results and method may be used as a reference for evaluating tolerance with different designs of gas masks.
Treatment of Respiratory Tract Infection and/or Acute Bronchitis With Ectoin Inhalation Solution...
BronchitisCough3 moreThis observational, non-interventional multicentric study compares the inhalation therapy on patients suffering on respiratory tract infections and/or acute bronchitis between Ectoin inhalation solution and Pari NaCl (0.9%) inhalation solution