Bronchoscopy versus an endotracheal tube mounted camera for the peri-interventional visualization of percutaneous dilatational tracheostomy - a prospective, randomized trial (VivaPDT).
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ABSTRACT: Percutaneous dilatational tracheostomy (PDT) in critically ill patients often involves bronchoscopic optical guidance. However, this procedure is not without disadvantages. Therefore, we aimed to study a recently introduced endotracheal tube-mounted camera (VivaSightTM-SL tube [VST]; ETView, Misgav, Israel) for guiding PDT.This was a randomized controlled trial involving 46 critically ill patients who received PDT using optical guidance with a VST or with bronchoscopy. The primary outcome measure was visualization of the tracheal structures (i.e., identification and monitoring of the thyroid, cricoid, and tracheal cartilage and the posterior wall) rated on 4-point Likert scales. Secondary measures were the quality of ventilation (before puncture and during the tracheostomy procedure rated on 4-point Likert scales) and blood gases sampled at standardized time points.The mean ratings for visualization (lower values better; values given for per-protocol analysis) were 5.4 (95% CI 4.5-6.3) for the VST group and 4.0 (95% CI 4.0-4.0) for the bronchoscopy group (p?CONCLUSIONSVisualization of PDT with the VST is not noninferior to guidance by bronchoscopy. Ventilation is superior with less hypercarbia with the VST. Because visualization is not a prerequisite for PDT, patients requiring stable ventilation with normocarbia may benefit from PDT with the VST.ClinicalTrials.gov, NCT02861001 . Registered on 13 June 2016.
Bronchoscopy versus an endotracheal tube mounted camera for the peri-interventional visualization of percutaneous dilatational tracheostomy - a prospective, randomized trial (VivaPDT).
<h4>Background</h4>Percutaneous dilatational tracheostomy (PDT) in critically ill patients often involves bronchoscopic optical guidance. However, this procedure is not without disadvantages. Therefore, we aimed to study a recently introduced endotracheal tube-mounted camera (VivaSight<sup>TM</sup>-SL tube [VST]; ETView, Misgav, Israel) for guiding PDT.<h4>Methods</h4>This was a randomized controlled trial involving 46 critically ill patients who received PDT using optical guidance with a VST or ...[more]
Project description:BackgroundThe current study investigates the effect of bronchoscopy-guided percutaneous dilatational tracheostomy (PDT) on the evolution of respiratory acidosis depending on endotracheal tube (ET) sizes. In addition, the impact of increasing tidal volumes during the intervention was investigated.MethodsTwo groups of ICU-patients undergoing bronchoscopy-guided PDT with varying tidal volumes and tube sizes were consecutively investigated: 6?ml/kg (N?=?29, mean age 57.4?±?14.5?years) and 12?ml/kg predicted body weight (N?=?34, mean age 59.5?±?12.8?years).ResultsThe mean intervention time during all procedures was 10?±?3?min. The combination of low tidal volumes and ETs of 7.5?mm internal diameter resulted in the most profound increase in PaCO2 (32.2?±?11.6?mmHg) and decrease in pH-value (-?0.18?±?0.05). In contrast, the combination of high tidal volumes and ETs of 8.5?mm internal diameter resulted in the least profound increase in PaCO2 (8.8?±?9.0?mmHg) and decrease of pH (-?0.05?±?0.04). The intervention-related increase in PaCO2 was significantly lower when using higher tidal volumes for larger ET: internal diameter 7.5, 8.0 and 8.5: P?>?0.05, =0.006 and?=?0.002, respectively. Transcutaneous PCO2 monitoring revealed steadily worsening hypercapnia during the intervention with a high correlation of 0.87 and a low bias of 0.7?±?9.4?mmHg according to the Bland-Altman analysis when compared to PaCO2 measurements.ConclusionsProfound respiratory acidosis following bronchoscopy-guided PDT evolves in a rapid and dynamic process. Increasing the tidal volume from 6 to 12?ml/kg PBW was capable of attenuating the evolution of respiratory acidosis, but this effect was only evident when using larger ETs.Trial registrationDRKS00011004 . Registered 20th September 2016.
Project description:INTRODUCTION:Bronchoscopy-guided percutaneous dilatational tracheostomy (BG-PDT) is an invasive procedure regularly performed in the intensive care unit. Risk of serious complications have been estimated in up to 5%, focused during the learning phase. We have not found any published formal training protocols, and commercial simulators are costly and not widely available in some countries. The objective of this study was to present the design and simulator performance of a low-cost BG-PDT simulator. METHODS:A simulator was designed with materials available in a hardware store, synthetic skin pads, ex vivo bovine tracheas, and a pipe inspection camera. The simulator was tested in 8 experts and 9 novices. Sessions were video recorded, and participants were equipped with the Imperial College Surgical Device, a hand motion-tracking device. Performance was evaluated with a multimodal approach, including first attempt success rate, global success rate, total procedural time, Imperial College Surgical Device-derived proficiency parameters, and global rating scale applied blindly by 2 expert observers. A satisfaction survey was applied after the procedure. RESULTS:A simulator was successfully constructed, allowing multiple iterations per assembly, with a fixed cost of US $30 and $4 per use. Experts had greater global and first attempt success rate, performed the procedure faster, and with greater proficiency. It presented high user satisfaction and fidelity. CONCLUSIONS:A low-cost BG-PDT simulator was successfully constructed, with the ability to discriminate between experts and novices, and with high fidelity. Considering its ease of construction and cost, it can be replicated in almost any intensive care unit.
Project description:BACKGROUND:For critically ill patients, effective airway management with a high first-attempt success rate for endotracheal intubation is essential to prevent hypoxic complications during securing of the airway. Video guidance may improve first-attempt success rate over direct laryngoscopy (DL). METHODS:With ethics approval, this randomised controlled trial involved 54 critically ill patients who received endotracheal intubation using a tube with an integrated video camera (VivaSight™-SL tube, VST, ETView Ltd., Misgav, Israel) or using conventional intubation under DL. RESULTS:The two groups did not differ in terms of intubation conditions. The first-attempt success rate was VST 96% vs. DL 93% (not statistically significant (n. s.)). When intubation at first attempt failed, it was successful in the second attempt in all patients. There was no difference in the median average time to intubation (VST 34 s (interquartile range 28-39) vs. DL 35 s (28-40), n. s.). Neither vomiting nor aspiration or accidental oesophageal intubation were observed in either group. The lowest pulsoxymetric oxygen saturation for VST was 96 (82-99) % vs. 99 (95-100) % for DL (n. s.). Hypotension defined as systolic blood pressure?<?70 mmHg occurred in the VST group at 20% vs. the DL group at 15% (n. s.). CONCLUSION:In this pilot study, no advantage was shown for the VST. The VST should be examined further to identify patient groups that could benefit from intubation with the VST, that is, patients with difficult airway conditions. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02837055 . Registered on 13 June 2016.
Project description:BackgroundPercutaneous dilatational tracheostomy (PDT) is increasingly popular within intensive care units for patients who need prolonged ventilatory support. Significant complications are rare.Case presentationOur patient suffered tracheal ring fracture and early tracheomalacia following this procedure. These complications are demonstrated in our accompanying video.ConclusionContrary to common beliefs, tracheal rings are commonly fractured during the PDT procedure. The consequent granulation can lead to tracheal stenosis and tracheomalacia.
Project description:BackgroundTracheostomy is one of the most frequent techniques in intensive care units (ICU). Fiberoptic bronchoscopy (FB) is a safety measure when performing a percutaneous dilatational tracheostomy (PDT), but the controversy surrounding the routine use of FB as part of the procedure remains open. National surveys in some European countries showed that the use of FB is non-standardized. Retrospective studies have not shown a significant difference in complications between procedures performed with or without a bronchoscope. International guidelines have not been able to establish recommendations regarding the use of FB in PDT due to lack of evidence.DesignThis is a multicenter (three centers at the time of publishing this paper) randomized controlled clinical trial to examine the safety of percutaneous tracheostomy using FB. We will include all consecutive adult patients admitted to the ICU in whom percutaneous tracheostomy for prolonged mechanical ventilation is indicated and with no exclusion criteria for using FB. Eligible patients will be randomly assigned to receive blind PDT or PDT under endoscopic guidance. All procedures will be performed by experienced intensivists in PDT and FB. A Data Safety and Monitoring Board (DSMB) will monitor the trial. The primary outcome is the incidence of perioperative complications.DiscussionFB is a safe technique when performing PDT although its use is not universally accepted in all ICUs as a routine practice. Should PDT be monitored routinely with endoscopic guidance? This study will assess the role of FB monitoring during PDT.Trial registrationClinicalTrials.gov NCT04265625. Registered on February 11, 2020.
Project description:INTRODUCTION: Tracheostomy is one of the more commonly performed procedures in critically ill patients yet the optimal method of performing tracheostomies in this population remains to be established. The aim of this study was to systematically review and quantitatively synthesize all randomized clinical trials (RCTs), comparing elective percutaneous dilatational tracheostomy (PDT) and surgical tracheostomy (ST) in adult critically ill patients with regards to major short and long term outcomes. METHODS: MEDLINE, EMBASE, CINAHL and the Cochrane Controlled Clinical Trials Register databases were searched to identify relevant studies. Additionally, bibliographies and selected conference proceedings were reviewed, and experts in the field and manufacturers of two PDT kits were contacted. Randomized clinical trials comparing any method of elective PDT to ST that included critically ill adults and reported at least one clinically relevant outcome were included. Data extracted included trial characteristics, measures of study validity, and clinically relevant outcomes. RESULTS: Seventeen RCTs involving 1,212 patients were included. Most PDTs used a multiple dilator technique and were performed in the intensive care unit (ICU). The pooled odds ratio (OR) for wound infection was 0.28 (95% confidence interval (CI), 0.16 to 0.49, p < 0.0005), indicating a significant reduction with PDT compared to ST. Overall, PDT was equivalent to ST for bleeding, major peri-procedural and long-term complications; however, subgroup analysis suggested PDT resulted in a lower incidence of bleeding (OR = 0.29 (95% CI 0.12 to 0.75, p = 0.01)) and death (OR = 0.71 (95% CI 0.50 to 1.0, p = 0.05)) when the STs were performed in the operating theatre. CONCLUSION: PDT reduces the overall incidence of wound infection and may further reduce clinical relevant bleeding and mortality when compared with ST performed in the operating theatre. PDT, performed in the ICU, should be considered the procedure of choice for performing elective tracheostomies in critically ill adult patients.
Project description:BackgroundBoth single-use and reusable bronchoscopes are suitable for percutaneous dilatational tracheostomy (PDT) to visualise the trachea during the insertion process. To determine the least costly option, the price of single-use bronchoscopes must be weighed against the estimated average cost of a bronchoscopy with reusable equipment. In the latter case, the acquisition cost must be spread over the equipment's useful life and other relevant costs, such as reprocessing and repair, must be included.ObjectiveThis study aimed to calculate the cost of using single-use or reusable bronchoscopes per PDT procedure.MethodsA systematic literature search was conducted to identify studies comparing the costs of reusable and single-use bronchoscopes for PDT. Inclusion criteria were articles assessing the cost of single-use or reusable bronchoscopes, and where costs were divided into acquisition, reprocessing, and repair costs. A questionnaire regarding repair rates and costs for reusable bronchoscopes was sent to 366 hospitals in the US, UK, and Germany to supplement the identified literature.ResultsEleven studies met the inclusion criteria. Ninety-nine completed responses were received, of which 31 hospitals used reusable equipment for PDT. Literature research revealed an average acquisition cost of $US135 (SD 152) and reprocessing cost of $US123 (SD 128). Additionally, a combination of data from the literature and the questionnaires gave a repair cost per use of $US148 (SD 242), resulting in a total average cost of $US406 for reusable bronchoscopes and $US249 (SD 36) for single-use bronchoscopes per PDT procedure. Thus, the incremental cost per use of a reusable bronchoscope compared with a single-use bronchoscope was $US157.ConclusionsWe conclude that significant savings can be made by using single-use bronchoscopes to guide PDT in preference to reusable bronchoscopes. Results depend on hospital setting, the reprocessing procedures, annual bronchoscope procedures, individual repair cost, and repair rates.
Project description:IntroductionSince the introduction and widespread acceptance of percutaneous techniques in the intensive care unit (ICU) setting, the number of critically ill patients undergoing tracheostomy has steadily increased. However, this procedure can be associated with major complications, including death. The purpose of this study is to estimate the incidence and analyze the causes of lethal complications due to percutaneous dilatational tracheostomy (PDT).MethodsWe analyzed cases of lethal outcome due to complications from PDT including cases published between 1985 and April 2013. A systematic literature search was performed and unpublished cases from our own departmental records were retrospectively analyzed.ResultsA total of 71 cases of lethal outcome following PDT were identified including 68 published cases and 3 of our own patients. The incidence of lethal complications was calculated to be 0.17%. Of the fatal complications, 31.0% occurred during the procedure and 49.3% within seven days of the procedure. The main causes of death were: hemorrhage (38.0%), airway complications (29.6%), tracheal perforation (15.5%), and pneumothorax (5.6%). We found specific risk factors for complications in 73.2% of patients, 25.4% of patients had more than one risk factor. Bronchoscopic guidance was used in only 46.5% of cases.ConclusionsAccording to this analysis, PDT-related death occurs in 1 out of 600 patients receiving a PDT. Careful patient selection, bronchoscopic guidance, and securing the tracheal cannula with sutures are likely to reduce complication rates.
Project description:BackgroundWe aimed to investigate the efficacy and safety of percutaneous dilatational tracheostomy procedure following cardiac surgery in patients receiving extracorporeal membrane oxygenation and/or left ventricular assist device.MethodsA total of 42 patients (10 males, 32 females; mean age 51±14.6 years; range, 18 to 77 years) who underwent percutaneous dilatational tracheostomy procedure under extracorporeal membrane oxygenation and/or left ventricular assist device support between January 2017 and January 2019 were retrospectively analyzed. Laboratory data, Simplified Acute Physiology Score-II and Sequential Organ Failure Assessment scores, and major and minor complications were recorded. The 30-day and one-year follow-up outcomes of the patients were reviewed.ResultsOf 42 patients, 17 (42.5%), 14 (33.3%), and 11 (26.2%) received left ventricular assist device, extracorporeal membrane oxygenation, and extracorporeal membrane oxygenation + left ventricular assist device, respectively. During percutaneous dilatational tracheostomy, the laboratory values of the patients were as follows: international normalized ratio, 2.3±0.9; partial thromboplastin time, 59.4±19.5 sec; platelet count, 139.2±65.8×109/L, hemoglobin, 8.8±1.0 g/dL, and creatinine, 1.6±1.0 mg/dL. No peri-procedural mortality, major complication, or bleeding was observed. We observed minor complications including localized stomal ooze in four patients (8.3%) and local stomal infection in three patients (6.2%).ConclusionOur study results suggest that percutaneous dilatational tracheostomy is an effective and safe technique in this patient population.
Project description:BackgroundTeaching and assessing clinical procedures requires a clear delineation of the individual steps required to successfully complete the procedure. For decades, human reliability analysis (HRA) has been used to identify the steps required to complete technical procedures in higher risk industries. However, the use of HRA is uncommon in healthcare. HRA has great potential supporting simulation-based education (SBE) in two ways: (1) to support training through the identification of the steps required to complete a clinical procedure; and (2) to support assessment by providing a framework for evaluating performance of a clinical procedure. The goal of this study was to use HRA to identify the steps (and the risk associated with each of these steps) required to complete a bronchoscope-assisted percutaneous dilatational tracheostomy (BPDT). BPDT is a potentially high-risk minimally invasive procedure used to facilitate tracheostomy placement at the bedside or in the operating theatre.MethodsThe subgoals, or steps, required to complete the BPDT procedure were identified using hierarchical task analysis. The Systematic Human Error Reduction and Prediction Approach (SHERPA) was then used to identify potential human errors at each subgoal, the level of risk and how these potential errors could be prevented.ResultsThe BPDT procedure was broken down into 395 subgoals, of which 18% were determined to be of high-risk. The most commonly identified remediation strategies for reducing the risk of the procedure included: checklist implementation and audit, statutory and mandatory training modules, simulation training, consultant involvement in all procedures, and fostering a safety-focused hospital culture.ConclusionThis study provides an approach for how to systematically identify the steps required to complete a clinical procedure for both training and assessment. An understanding of these steps is the foundation of SBE. HRA can identify 'a correct way' for teaching learners how to complete a technical procedure, and support teachers to give systematic and structured feedback on performance.