scholarly journals Time to adapt in the pandemic era: A prospective randomized non–inferiority  study comparing time to intubate  with and without  the barrier box

2020 ◽  
Author(s):  
Praneeth Madabhushi ◽  
Sudhakar Kinthala ◽  
Abistanand Ankam ◽  
Nitin Chopra ◽  
Burdett Porter
Keyword(s):  
Management Practices ◽  
Controlled Trial ◽  
Peripheral Nerve Stimulator ◽  
Secondary Endpoints ◽  
The Mean ◽  
The Difference ◽  
Clinically Significant ◽  
Induction Times ◽  
End Tidal ◽  
Bag Mask Ventilation

Abstract Background The challenges posed by the spread of COVID-19 disease through aerosols have compelled anesthesiologists to modify their airway management practices. Devices such as barrier boxes are being considered as potential adjuncts to full PPE's to limit the aerosol spread. Usage of the barrier box raises concerns of delay in time to intubate (TTI). We designed our study to determine if using a barrier box with glidescope delays TTI within acceptable parameters to make relevant clinical conclusions.Methods 78 patients were enrolled in this prospective non inferiority controlled trial and were randomly allocated to group C (without the barrier box) or the study group BB (using barrier box). The primary measured endpoint is time to intubate (TTI), which is defined as time taken from loss of twitches confirmed with a peripheral nerve stimulator to confirmation of end-tidal CO 2. 15 seconds was used as non-inferiority margin for the purpose of the study .We used an unpaired two-sample single-sided t-test to test our non- inferiority hypothesis (H 0 : Mean TTI diff ≥ 15 seconds, H A : Mean TTI diff < 15 seconds). Secondary endpoints include the number of attempts at intubation, lowest oxygen saturation during induction, and the need for bag-mask ventilation.Results Mean TTI in group C was 42 (CI 19.2 to 64.8) seconds vs. 52.1 (CI 26.1 to 78) seconds in group BB. The difference in mean TTI was 10.1 seconds (CI -∞ to 14.9). We rejected the null hypothesis and concluded with 95% confidence that the difference of the mean TTI between the groups is less than < 15 seconds (95% CI -∞ to 14.9,p = 0.0461). Our induction times were comparable (67.7 vs. 65.9 seconds).100% of our patients were intubated on the first attempt in both groups. None of our patients needed rescue breaths.Conclusions We conclude that in patients with normal airway exam, scheduled for elective surgeries, our barrier box did not cause any clinically significant delay in TTI when airway manipulation is performed by well-trained providers.The study was retrospectively registered at clinicaltrials.gov (NCT04411056) on May 27, 2020

scholarly journals Time to adapt in the pandemic era: a prospective randomized non –inferiority study comparing time to intubate with and without the barrier box

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Praneeth Madabhushi ◽  
Sudhakar Kinthala ◽  
Abistanand Ankam ◽  
Nitin Chopra ◽  
Burdett R. Porter
Keyword(s):  
Management Practices ◽  
Controlled Trial ◽  
Peripheral Nerve Stimulator ◽  
S 100 ◽  
Secondary Endpoints ◽  
The Difference ◽  
Clinically Significant ◽  
Induction Times ◽  
End Tidal ◽  
Bag Mask Ventilation

Abstract Background The challenges posed by the spread of COVID-19 disease through aerosols have compelled anesthesiologists to modify their airway management practices. Devices such as barrier boxes are being considered as potential adjuncts to full PPE’s to limit the aerosol spread. Usage of the barrier box raises concerns of delay in time to intubate (TTI). We designed our study to determine if using a barrier box with glidescope delays TTI within acceptable parameters to make relevant clinical conclusions. Methods Seventy-eight patients were enrolled in this prospective non-inferiority controlled trial and were randomly allocated to either group C (without the barrier box) or the study group BB (using barrier box). The primary measured endpoint is time to intubate (TTI), which is defined as time taken from loss of twitches confirmed with a peripheral nerve stimulator to confirmation of end-tidal CO 2. 15 s was used as non-inferiority margin for the purpose of the study. We used an unpaired two-sample single-sided t-test to test our non- inferiority hypothesis (H 0: Mean TTI diff ≥15 s, H A: Mean TTI diff < 15 s). Secondary endpoints include the number of attempts at intubation, lowest oxygen saturation during induction, and the need for bag-mask ventilation. Results Mean TTI in group C was 42 s (CI 19.2 to 64.8) vs. 52.1 s (CI 26.1 to 78) in group BB. The difference in mean TTI was 10.1 s (CI -∞ to 14.9). We rejected the null hypothesis and concluded with 95% confidence that the difference of the mean TTI between the groups is less than < 15 s (95% CI -∞ to 14.9,p = 0.0461). Our induction times were comparable (67.7 vs. 65.9 s).100% of our patients were intubated on the first attempt in both groups. None of our patients needed rescue breaths. Conclusions We conclude that in patients with normal airway exam, scheduled for elective surgeries, our barrier box did not cause any clinically significant delay in TTI when airway manipulation is performed by well-trained providers. The study was retrospectively registered at clinicaltrials.gov (NCT04411056) on May 27, 2020.

Alveolar carbon monoxide: A comparison of methods of measurement and a study of the effect of change in body posture

1988 ◽  
Vol 74 (1) ◽  
pp. 23-28 ◽  
Author(s):  
Andrew J. T. Kirkham ◽  
Andrew R. Guyatt ◽  
Gordon Cumming
Keyword(s):  
Carbon Monoxide ◽  
Linear Models ◽  
Body Posture ◽  
Breath Hold ◽  
Erect Posture ◽  
Indirect Measures ◽  
The Mean ◽  
The Difference ◽  
End Tidal ◽  
Inspired Oxygen

1. We have compared rebreathing, breath-hold and mean alveolar methods of measuring alveolar carbon monoxide (CO), at levels similar to those found in smokers, as a preliminary to using them as indirect measures of carboxyhaemoglobin levels. In the present study alveolar CO levels were raised by rebreathing a 2% CO mixture. 2. Breath-hold CO was measured after breath-hold times of 0–35 s in 5 s increments. Using generalized linear models, the maximum value for breath-hold CO was estimated to occur at 23 s. Breath-hold CO after a 20 and 25 s breath-hold were similar to and significantly greater than those of less than 20 s or greater than 25 s. 3. As expired CO increased, the difference between breath-hold and mean alveolar CO became proportionally larger. On average, breath-hold CO was 24% larger than mean alveolar CO. 4. Rebreathing, breath-hold and mean alveolar CO were compared at four different inspired oxygen concentrations. Expired CO increased significantly with increasing oxygen for all three methods. At end-tidal oxygen levels of less than 25%, breath-hold and rebreathing CO were similar, however, the overall mean difference between the three methods was significant. 5. While rebreathing CO was unaffected by changes in ventilation/perfusion of the lung, induced by change in body posture, both breath-hold and mean alveolar CO showed a significant fall with change from the supine to erect posture. 6. We conclude that under normoxic conditions, rebreathing and breath-hold CO (20 or 25 s breath-hold) were similar, whereas the mean alveolar method produced significantly lower values, presumably due to lack of equilibration. Altering ventilation/perfusion of the lung caused no mean change in the measurement of rebreathing CO but did affect the other methods.

scholarly journals Ideal sedation for stroke thrombectomy: a prospective pilot single-center observational study

2019 ◽  
Vol 46 (2) ◽  
pp. E16 ◽  
Author(s):  
M. Asif Taqi ◽  
Sajid S. Suriya ◽  
Ajeet Sodhi ◽  
Syed A. Quadri ◽  
Mudassir Farooqui ◽  
...  
Keyword(s):  
Interventional Radiology ◽  
Ischemic Stroke ◽  
Controlled Trial ◽  
Time Interval ◽  
Open Label ◽  
Anterior Circulation ◽  
Clinical Trial Registration ◽  
Female Ratio ◽  
The Mean ◽  
The Difference

OBJECTIVESeveral retrospective studies have supported the use of conscious sedation (CS) over general anesthesia (GA) as the preferred methods of sedation for stroke thrombectomy, but a recent randomized controlled trial showed no difference in outcomes after CS or GA. The purpose of the Ideal Sedation for Stroke Thrombectomy (ISST) study was to evaluate the difference in time and outcomes in the reperfusion of anterior circulation in ischemic stroke using GA and monitored anesthesia care (MAC).METHODSThe ISST study was a prospective, open-label registry. A total of 40 patients who underwent mechanical thrombectomy for anterior circulation ischemic stroke were enrolled. Informed consent was obtained from each patient before enrollment. The primary endpoint included the interval between the patient’s arrival to the interventional radiology room and reperfusion time. Secondary endpoints were evaluated to estimate the effects on the outcome of patients between the 2 sedation methods.RESULTSOf the 40 patients, 32 received thrombectomy under MAC and 8 patients under GA. The male-to-female ratio was 18:14 in the MAC group and 4:4 in the GA group. The mean time from interventional radiology room arrival to reperfusion in the GA group was 2 times higher than that in the MAC group. Complete reperfusion (TICI grade 3) was achieved in more than 50% of patients in both groups. The mean modified Rankin Scale score at 3 months was < 2 in the MAC group and > 3 in the GA group (p = 0.021).CONCLUSIONSThe findings from the pilot study showed a significantly shorter time interval between IR arrival and reperfusion and better outcomes in patients undergoing reperfusion for ischemic stroke in the anterior circulation using MAC compared with GA.Clinical trial registration no.: NCT03036631 (clinicaltrials.gov)

scholarly journals Lactulose versus lactitol in acute hepatic encephalopathy (HE).

2020 ◽  
Vol 27 (08) ◽  
pp. 1595-1601
Author(s):  
Shahid Rasool ◽  
Salman Azhar ◽  
Talha Munir ◽  
Mian Sajjad Ahmad ◽  
Rizwan Abbas ◽  
...  
Keyword(s):  
Hepatic Encephalopathy ◽  
Controlled Trial ◽  
P Value ◽  
Chi Square ◽  
Female Ratio ◽  
Study Results ◽  
Level Of Consciousness ◽  
Acute Hepatic Encephalopathy ◽  
The Mean ◽  
The Difference

Hepatic encephalopathy (HE), a syndrome observed in some patients with cirrhosis, with depressed level of consciousness. Lactulose as well as lactitol has been used in the treatment of HE. Lactitol is comparable to lactulose in the treatment of HE with fewer side effects and better tolerated. However, literature showed equal efficacy of both drugs. So we conducted this trial to find better drug to implement its use in future. Objective: To compare the effectiveness of lactulose and lactitol in patients with acute hepatic encephalopathy. Study Design: Randomized Controlled Trial. Setting: Department of Medicine OPD and Emergency (East, West, North, South), Mayo Hospital, Lahore. Period: 6 Months June 2017 to Dec 2017. Material & Methods: 570 patients were included through non-probability, consecutive sampling after informed consent. Initial grade of HE was assessed and patients were randomly divided in two groups by using lottery method i.e. lactulose or lactitol. Patients were admitted to ward for management and kept under observation for 5 days. After 5 days, HE grades was measured again, then improvement in grade of HE (effectiveness) was measured. All data was entered and analyzed by using SPSS version 21.0. Chi-square was applied to compare both groups for effectiveness taking p-value≤0.05 as significant. Results: In this study the mean age of the patients was 44.22 ±11.81 years, the male to female ratio of the patients was 2.4:1. The mean duration of the cirrhosis of the patients was 3.73±1.61 months. In our study the effectiveness was achieved in 538 (94.39%) patients, out of which 263 cases were from lactulose group and 275 were from lactitol group and the difference was significant (p<0.0.5). Conclusion: Our study results concluded that Lactitol is better choice for the treatment of patients with acute hepatic encephalopathy as compared to lactulose. More efficacy was achieved in lactitol group patients than in lactulose group patients.

scholarly journals Design and rationale of randomized, double-blind trial of the efficacy and safety of pirfenidone in patients with fibrotic hypersensitivity pneumonitis

2021 ◽  
pp. 00054-2021
Author(s):  
Evans R. Fernández Pérez ◽  
James L. Crooks ◽  
Jeffrey J. Swigris ◽  
Joshua J. Solomon ◽  
Michael P. Mohning ◽  
...  
Keyword(s):  
Hypersensitivity Pneumonitis ◽  
Controlled Trial ◽  
Lung Parenchyma ◽  
Double Blind ◽  
Safety And Efficacy ◽  
Secondary Endpoints ◽  
The Mean ◽  
Predicted Values ◽  
Study Participants ◽  
To Receive

Hypersensitivity pneumonitis (HP) is an immunologically mediated form of lung disease resulting from inhalational exposure to any of a large variety of antigens. A subgroup of patients with HP develops pulmonary fibrosis (fibrotic HP, FHP), a significant cause of morbidity and mortality. This study will evaluate the safety and efficacy of the antifibrotic pirfenidone in treating FHP.This single-center, randomized, double-blind, placebo-controlled trial is enrolling adults with FHP (ClinicalTrials.gov: NCT02958917). Study participants must have fibrotic abnormalities involving ≥5% of the lung parenchyma on high-resolution CT scan, forced vital capacity ≥40% and diffusing capacity of the lung for carbon monoxide ≥30% of predicted values. Study participants will be randomized in a 2:1 ratio to receive pirfenidone 2403 mg·d−1 or placebo. The primary efficacy endpoint is the mean change in %FVC from baseline to week 52. A number of secondary endpoints have been chosen to evaluate the safety and efficacy in different domains.

scholarly journals A Randomized Controlled Trial of Four Precolonoscopy Bowel Cleansing Regimens

2011 ◽  
Vol 25 (12) ◽  
pp. 657-662 ◽  
Author(s):  
Dina Kao ◽  
Eoin Lalor ◽  
Gurpal Sandha ◽  
Richard N Fedorak ◽  
Bloeme van der Knoop ◽  
...  
Keyword(s):  
Bowel Preparation ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Short Interval ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Bowel Cleansing ◽  
The Mean ◽  
Clinically Significant ◽  
The Ideal

BACKGROUND: The ideal bowel cleansing regimen for colonoscopy has yet to be determined.OBJECTIVE: To compare the cleansing efficacy, and patient tolerability and safety of four bowel preparation regimens.METHODS: A total of 834 patients undergoing outpatient colonoscopy were randomly assigned to one of four regimens: 4 L polyethylene glycol (PEG); 2 L PEG + 20 mg bisacodyl; 90 mL of sodium phosphate (NaP); or two sachets of a commercially available bowel cleansing solution (PSMC) + 300 mL of magnesium citrate (M). The primary outcome measure was cleansing efficacy, which was scored by blinded endoscopists using the Ottawa Bowel Preparation Scale. Secondary outcome measures were bowel preparation quality according to time of colonoscopy, and patient tolerability and safety.RESULTS: The mean total cleansing score was significantly worse in the NaP group compared with the other three groups (P<0.0001). The mean cleansing scores were worse in patients who underwent morning versus afternoon colonoscopy, a finding that was consistent in all four groups. PSMC + M was the best tolerated regimen. No clinically significant mean changes in creatinine or electrolyte levels were identified, although a significantly higher proportion of patients in the NaP group developed hypokelemia (P<0.0001).CONCLUSIONS: 2 L PEG + 20 mg bisacodyl, or PSMC + M was as efficacious as 4 L PEG and superior to NaP for bowel cleansing. A short interval between the completion of bowel preparation and the start of colonoscopy (ie, ‘runway time’), irrespective of bowel preparation regimen, appeared to be a more important predictor of bowel cleanliness than the cathartic agents used.

Prevalence of Eimeria infection and risk factors associated with domestic chickens raised in Nsukka LGA, Enugu State, Southeast Nigeria

2021 ◽  
Vol 42 (2) ◽  
pp. 294-301
Author(s):  
E.S. Okwuonu ◽  
C.M. Eneh ◽  
E.N. Elijah ◽  
F.N. Nnaji ◽  
F.A. Andong ◽  
...  
Keyword(s):  
Management Practices ◽  
Protozoan Parasite ◽  
Poultry Production ◽  
Protozoan Infection ◽  
Faecal Samples ◽  
Significant Difference ◽  
High Incidence ◽  
The Mean ◽  
The Difference ◽  
Eimeria Infection

Eimeria infection has been considered the most important protozoan infection of the poultry industry in Nigeria because of its high incidence. A total of 400 faecal samples were collected from 10 farms in Nsukka LGA and analyzed using the Wisconsin’s faecal floatation technique. Data on the management practices of these farms were collected using a wellstructured questionnaire. Eimeria tenella was the only identified species. A total of 158 (39.5%) of the domestic chickens sampled were infected with the protozoan parasite. There was significant difference (p < 0.0001) of E. tenella between towns and between the studied farms. Of the 5 towns sampled, the prevalence was highest at Obukpa town 52 (65.0%) and in birds aged 7 weeks 20 (83.3%) and least at Edem 2 (2.5%) and in birds aged 32 weeks 2 (5.0%). The mean intensity of infection was highest at Obukpa (9.35 ± 9.24) and in birds aged 4weeks (11.50 ± 11.09) and least in Edem town and in birds aged 32 weeks. The difference in prevalence between birds of different ages was significant (p <0.0001). Majority of the farms practiced deep litter housing compared to battery cage users (90% vs. 10%). The most used vaccine was combination 7 (70%). Fifty percent of the farms employed the expertise of veterinary doctors in vaccine administration. Eimeria infection, the main cause of coccidiosis in chicken, has continued to be a major challenge in poultry production and management. Conclusively, the prevalence of Eimeria infection is moderately low as a result of the widespread use of vaccines and anticoccidials.

Randomized Controlled Trial to Evaluate Regional Citrate Anticoagulation Plus Low-Dose of Dalteparin in Continuous Veno-Venous Hemofiltration

2015 ◽  
Vol 39 (4) ◽  
pp. 306-312 ◽  
Author(s):  
Buyun Wu ◽  
Kaiyue Zhang ◽  
Bin Xu ◽  
Daxi Ji ◽  
Zhihong Liu ◽  
...  
Keyword(s):  
Low Dose ◽  
Controlled Trial ◽  
Regional Citrate Anticoagulation ◽  
Citrate Anticoagulation ◽  
Normal Dose ◽  
Mean Filter ◽  
Secondary Endpoints ◽  
Group A ◽  
The Mean ◽  
Group B

Background/Aims: To evaluate the efficacy and safety of regional citrate anticoagulation (RCA) plus low-dose dalteparin in patients receiving continuous veno-venous hemofiltration (CVVH). Methods: Patients requiring pre-dilution CVVH at 4 l/h were randomly assigned to group A (RCA only), group B (normal-dose dalteparin anticoagulation only) or group C (RCA plus low-dose dalteparin). The primary endpoint was filter runtime and the secondary endpoints were premature clotting of the filter and anticoagulation-related side effects. Results: Fifty-three patients completed the study. The mean filter runtime was significantly longer in group C (40.4 ± 30.9 h) than those in group A (21.2 ± 13.5 h, p = 0.006) and group B (25.1 ± 24.0 h, p = 0.040). The rate of premature clotting, new onset of bleeding, hypocalcemia and metabolic acidosis did not differ significantly in three groups. Conclusions: RCA plus low-dose dalteparin prolonged filter runtime compared with RCA only or normal-dose dalteparin only without increasing the incidence of anticoagulation-related complications.

scholarly journals International normalized ratio (INR) testing in Europe: between-laboratory comparability of test results obtained by Quick and Owren reagents

2018 ◽  
Vol 56 (10) ◽  
pp. 1698-1703 ◽  
Author(s):  
Piet Meijer ◽  
Karin Kynde ◽  
Antonius M.H.P. van den Besselaar ◽  
Marjan Van Blerk ◽  
Timothy A.L. Woods
Keyword(s):  
Plasma Sample ◽  
International Normalized Ratio ◽  
Test Results ◽  
Local Calibration ◽  
The Mean ◽  
The Difference ◽  
Clinically Significant ◽  
Single Plasma ◽  
Better Than

Abstract Background: This study was designed to obtain an overview of the analytical quality of the prothrombin time, reported as international normalized ratio (INR) and to assess the variation of INR results between European laboratories, the difference between Quick-type and Owren-type methods and the effect of using local INR calibration or not. In addition, we assessed the variation in INR results obtained for a single donation in comparison with a pool of several plasmas. Methods: A set of four different lyophilized plasma samples were distributed via national EQA organizations to participating laboratories for INR measurement. Results: Between-laboratory variation was lower in the Owren group than in the Quick group (on average: 6.7% vs. 8.1%, respectively). Differences in the mean INR value between the Owren and Quick group were relatively small (<0.20 INR). Between-laboratory variation was lower after local INR calibration (CV: 6.7% vs. 8.6%). For laboratories performing local calibration, the between-laboratory variation was quite similar for the Owren and Quick group (on average: 6.5% and 6.7%, respectively). Clinically significant differences in INR results (difference in INR>0.5) were observed between different reagents. No systematic significant differences in the between-laboratory variation for a single-plasma sample and a pooled plasma sample were observed. Conclusions: The comparability for laboratories using local calibration of their thromboplastin reagent is better than for laboratories not performing local calibration. Implementing local calibration is strongly recommended for the measurement of INR.

scholarly journals Redefining Non-Inferiority in Anamnestic Antibody Responses Using the Mean Increase of Log-Transformed Antibody Titers after Revaccination: Secondary Analysis of a Randomized Controlled Rabies Vaccination Trial

Vaccines ◽  
2020 ◽  
Vol 8 (4) ◽  
pp. 721
Author(s):  
Lisanne A. Overduin ◽  
Patrick H. P. Soentjens ◽  
Jelle J. Goeman ◽  
Magdalena A. Berkowska ◽  
Jacques J. M. van Dongen ◽  
...  
Keyword(s):  
Antibody Response ◽  
Controlled Trial ◽  
Secondary Analysis ◽  
Neutralizing Antibody ◽  
Primary Vaccination ◽  
Vaccination Schedule ◽  
Randomized Controlled ◽  
Antibody Titers ◽  
The Mean ◽  
The Difference

Non-inferiority in the anamnestic antibody response is conventionally determined by comparing seroconversion rates after revaccination. However, this approach is inadequate in the case of high pre-booster antibody titers. Therefore, we propose an alternative method to determine non-inferiority of booster responses. We used anonymized data from a randomized controlled trial (NCT01388985; EudraCT 2011-001612-62) in 500 adults, comparing a two-visit primary vaccination schedule (two intradermal 0.1 mL rabies vaccine doses on day 0 and 7) with a three-visit schedule (single intradermal 0.1 mL dose on day 0, 7, and 28). Participants were revaccinated intradermally (single dose) 1 to 3 years later. Rabies virus neutralizing antibody titers were measured on day 0 and 7 after revaccination. After log3-transformation of antibody titers, the mean increase in titers after revaccination was compared between schedules. Non-inferiority was defined as the lower bound of the two-sided 95% confidence interval not exceeding −0.369. Four hundred and ten participants fulfilled the inclusion criteria. The mean increase in log3 titer was 2.21 and 2.31 for the two-visit and three-visit schedule, respectively. The difference between these increases was −0.10 [−0.28, 0.08], meeting the non-inferiority criterion. In conclusion, comparing mean increases in log-transformed titers after revaccination appears to be a feasible and more informative method of studying non-inferiority regarding the anamnestic antibody response.

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