scholarly journals Complications Associated With Removal of Airway Devices Under Deep Anesthesia In Children: An Analysis of The Wake Up Safe Database

Author(s):  
Lisa Vitale ◽  
Briana Rodriguez ◽  
Anne Baetzel ◽  
Robert Christensen ◽  
Bishr Haydar

Abstract Background: Previous studies examining removal of endotracheal tubes and supraglottic devices under deep anesthesia were underpowered to identify rare complications. This study sought to report all adverse events associated with this practice found in a large national database of pediatric anesthesia adverse events.Methods: An extract of an adverse events database created by the Wake Up Safe database, a multi-institutional pediatric anesthesia quality improvement initiative, was performed for this study. It was screened to identify anesthetics with variables indicating removal of airway devices under deep anesthesia. Three anesthesiologists screened the data to identify events where this practice possibly contributed to the event. Event data was extracted and collated. Results: 102 events met screening criteria and 66 met inclusion criteria. Two cardiac etiology events were identified, one of which resulted in the patient’s demise. The remaining 97% of events were respiratory in nature (64 events), including airway obstruction, laryngospasm, bronchospasm and aspiration. Some respiratory events consisted of multiple distinct events in series. Nineteen respiratory events resulted in cardiac arrest (29.7%) of which 15 (78.9%) were deemed preventable by local anesthesiologists performing independent review. Respiratory events resulted in intensive care unit admission (37.5%), prolonged intubation and temporary neurologic injury but no permanent harm. Provider and patient factors were root causes in most events. Upon investigation, areas for improvement identified included improving patient selection, ensuring monitoring, availability of intravenous access, and access to emergency drugs and equipment until emergence.Conclusions: Serious adverse events have been associated with this practice, but no respiratory events were associated with long-term harm.

2019 ◽  
Vol 29 (3) ◽  
pp. 265-270 ◽  
Author(s):  
Robert E. Christensen ◽  
Rebecca C. Nause-Osthoff ◽  
Jeffrey C. Waldman ◽  
Daniel E. Spratt ◽  
Jason W. D. Hearn

2017 ◽  
Vol 157 (4) ◽  
pp. 716-721 ◽  
Author(s):  
Jeffrey Cheng ◽  
Beiyu Liu ◽  
Alfredo E. Farjat ◽  
David W. Jang

Objective Identify predictors of adverse events for children who underwent endoscopic sinus surgery for treatment of orbital complications associated with sinusitis. Study Design Cross-sectional analysis of a US national database. Setting American College of Surgeons National Surgical Quality Improvement Program (NSQIP), pediatric version (2012-2015). Subjects and Methods Patients were identified with a combination of codes from the International Classification of Diseases, Ninth Revision and 2014 Current Procedural Terminology. Our primary outcome measure was adverse events, which were compared with clinical risk factors to examine for any associations. Results A total of 57 patients were included for analysis. No significant relationship was identified between 30-day postoperative adverse events and age, sex, race, body mass index, prematurity, history of asthma, steroid use (within 30 days), and preoperative white blood cell count. There was a statistically significant increase in adverse events for those patients who underwent delayed surgery ( P < .0001). No serious adverse events related to death, sepsis, nerve injury (eg, visual loss), or other organ space infections (eg, intracranial infection) were identified. After controlling for age group and race, delayed operative intervention was a significant clinical predictor of adverse events (odds ratio = 25.65; 95% CI, 3.86-170.45; P = .0008). We observed unplanned reoperation and readmission rates of 5.3% and 7%, respectively. Conclusions Endoscopic surgical drainage for infectious orbital complications of sinusitis in children appears to be safe. Serious or significant adverse events were uncommon. Areas for improvement include limiting and reducing unplanned reoperations and readmissions.


2013 ◽  
Vol 154 (3) ◽  
pp. 83-92
Author(s):  
Mariann Harangi ◽  
Noémi Zsíros ◽  
Lilla Juhász ◽  
György Paragh

Statin therapy is considered to be safe and rarely associated with serious adverse events. However, a significant proportion of patients on statin therapy show some degree of intolerance which can lead to decreased adherence to statin therapy. The authors summarize the symptoms, signs and frequencies of the most common statin-induced adverse effects and their most important risk factors including some single nucleotide polymorphisms and gene mutations. Also, they review the available approaches to detect and manage the statin-intolerant patients. Orv. Hetil., 2013, 154, 83–92.


2020 ◽  
Vol 132 (6) ◽  
pp. 2000-2007 ◽  
Author(s):  
Soroush Niketeghad ◽  
Abirami Muralidharan ◽  
Uday Patel ◽  
Jessy D. Dorn ◽  
Laura Bonelli ◽  
...  

Stimulation of primary visual cortices has the potential to restore some degree of vision to blind individuals. Developing safe and reliable visual cortical prostheses requires assessment of the long-term stability, feasibility, and safety of generating stimulation-evoked perceptions.A NeuroPace responsive neurostimulation system was implanted in a blind individual with an 8-year history of bare light perception, and stimulation-evoked phosphenes were evaluated over 19 months (41 test sessions). Electrical stimulation was delivered via two four-contact subdural electrode strips implanted over the right medial occipital cortex. Current and charge thresholds for eliciting visual perception (phosphenes) were measured, as were the shape, size, location, and intensity of the phosphenes. Adverse events were also assessed.Stimulation of all contacts resulted in phosphene perception. Phosphenes appeared completely or partially in the left hemifield. Stimulation of the electrodes below the calcarine sulcus elicited phosphenes in the superior hemifield and vice versa. Changing the stimulation parameters of frequency, pulse width, and burst duration affected current thresholds for eliciting phosphenes, and increasing the amplitude or frequency of stimulation resulted in brighter perceptions. While stimulation thresholds decreased between an average of 5% and 12% after 19 months, spatial mapping of phosphenes remained consistent over time. Although no serious adverse events were observed, the subject experienced mild headaches and dizziness in three instances, symptoms that did not persist for more than a few hours and for which no clinical intervention was required.Using an off-the-shelf neurostimulator, the authors were able to reliably generate phosphenes in different areas of the visual field over 19 months with no serious adverse events, providing preliminary proof of feasibility and safety to proceed with visual epicortical prosthetic clinical trials. Moreover, they systematically explored the relationship between stimulation parameters and phosphene thresholds and discovered the direct relation of perception thresholds based on primary visual cortex (V1) neuronal population excitation thresholds.


2019 ◽  
Vol 14 (1) ◽  
pp. 31-36
Author(s):  
Raafat Abdel-Malek ◽  
Kyrillus S. Shohdy ◽  
Noha Abbas ◽  
Mohamed Ismail ◽  
Emad Hamada ◽  
...  

Background: Several single chemotherapeutic agents have been evaluated as the second-line treatment of advanced urothelial carcinoma. Despite encouraging efficacy outcomes, toxicity has often led to dose modifications or discontinuation. We aimed to assess the safety of vinflunine in a particular population of advanced transitional cell carcinoma of urothelium (TCCU), that were exposed to the previous toxicity of chemotherapy. Methods: This is an open-label, prospective, single-center pilot study to evaluate the response rate and safety profile of vinflunine in patients with advanced TCCU. It was planned to enroll 25 evaluable patients. Eligible patients are those with progressive disease after first-line platinum-based regimen for advanced or metastatic disease. Results: The study was prematurely closed due to two sudden deaths that were judged by the review board as treatment-related. Only ten patients were evaluated and received at least one cycle of vinflunine. All but one were male and seven underwent radical surgery. Eight had a distant metastasis (mainly lung and/or liver). Disease control rate was 40%, four patients had a partial response with median duration of response of 3.5 months. The median overall survival was 3.2 months (95% CI:1.67- 4.73). There were three serious adverse events namely two sudden deaths and one grade 4 thrombocytopenia. Nine grade 3/4 adverse events occurred. The most common all-grade adverse events were fatigue (50%), constipation (40%) and vomiting (40%). Moreover, grade 3 fatigue occurred in 30% of patients. Only one patient, who achieved PR for 5 months, was fit to receive further cytotoxic chemotherapy. Conclusion: The activity of vinflunine in advanced urothelial carcinoma came at the expense of its safety. The use of vinflunine has to be limited to the selected group of patients. However, this is a single institute experience in a limited number of patients.


2021 ◽  
pp. 174749302110069
Author(s):  
Heidi Janssen ◽  
Louise Ada ◽  
Sandy Middleton ◽  
Michael Pollack ◽  
Michael Nilsson ◽  
...  

Background: Environmental enrichment involves organisation of the environment and provision of equipment to facilitate engagement in physical, cognitive and social activity. In animals with stroke, it promotes brain plasticity and recovery. Aims: To assess the feasibility and safety of a patient-driven model of environmental enrichment incorporating access to communal and individual environmental enrichment. Methods: A non-randomised cluster trial with blinded measurement involving people with stroke (n=193) in 4 rehabilitation units was carried out. Feasibility was operationalised as activity 10 days after admission to rehabilitation and availability of environmental enrichment. Safety was measured as falls and serious adverse events. Benefit was measured as clinical outcomes at 3 months, by an assessor blinded to group. Results: The experimental group (n=91) spent 7% (95% CI -14 to 0) less time inactive, 9% (95% CI 0 to 19) more time physically, and 6% (95% CI 2 to 10) more time socially active than the control group (n=102). Communal environmental enrichment was available 100% of the time, but individual environmental enrichment was rarely within reach (24%) or sight (39%). There were no between-group differences in serious adverse events or falls at discharge or 3 months nor in clinical outcomes at 3 months. Conclusions: This patient-driven model of environmental enrichment was feasible and safe. However, the very modest increase in activity by people with stroke, and the lack of benefit in clinical outcomes 3 months after stroke do not provide justification for an efficacy trial. Clinical Trial Registration: ANZCTR 12613000796785 Words: 245


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