Prospective development study of the Versius Surgical System for use in transoral robotic surgery: an IDEAL stage 1/2a first in human and initial case series experience.

PURPOSE: Transoral robotic surgery is well established in the treatment paradigm of oropharyngeal pathology. The Versius Surgical System (CMR Surgical) is a robotic platform in clinical use in multiple specialities but is currently untested in the head and neck. This study utilises the IDEAL framework of surgical innovation to prospectively evaluate and report a first in human clinical experience and single centre case series of transoral robotic surgery (TORS) with Versius. METHODS: Following IDEAL framework stages 1 and 2a, the study evaluated Versius to perform first in human TORS before transitioning from benign to malignant cases. Iterative adjustments were made to system setup, instrumentation, and technique, recorded in accordance with IDEAL recommendations. Evaluation criteria included successful procedure completion, setup time, operative time, complications, and subjective impressions. Further evaluation of the system to perform four-arm surgery was conducted. RESULTS: 30 TORS procedures were successfully completed (15 benign, 15 malignant) without intraoperative complication or conversion to open surgery. Setup time significantly decreased over the study period. Instrumentation challenges were identified, urging the need for TORS-specific instruments. The study introduced four-arm surgery, showcasing Versius' unique capabilities, although limitations in distal access were observed. CONCLUSIONS: TORS is feasible with the Versius Surgical System. The development of TORS-specific instruments would benefit performance and wider adoption of the system. 4-arm surgery is possible however further evaluation is required. Multicentre evaluation (IDEAL stage 2b) is recommended.

New robotic platform for transoral robotic surgery: an IDEAL stage 0 study.

Objectives: This study aims to assess the feasibility to perform transoral robotic surgery (TORS) with a new robotic platform, the Versius Surgical System (CMR Surgical, UK) in a preclinical cadaveric setting in accordance to stage 0 of the IDEAL-D framework. Design: IDEAL stage 0 preclinical assessment of the Versius Robotic System in TORS in human cadavers. Setting: All procedures were performed in a simulated operating theatre environment at a UK surgical training centre. Participants: 11 consultant head and neck surgeons from the UK, mainland Europe and the USA took part in TORS procedures on six human cadavers. Interventions: 3 key index procedures were assessed that represent the core surgical workload of TORS: lateral oropharyngectomy, tongue base resection and partial supraglottic laryngectomy. Main outcome measures: The primary outcome was the successful completion of each surgical procedure. Secondary outcomes included the optimisation of system setup, instrumentation and surgeon-reported outcomes for feasibility of each component procedural step. Results: 33 cadaveric procedures were performed and 32 were successfully completed. One supraglottic laryngectomy was not fully completed due to issues dividing the epiglottic cartilage with available instrumentation. Surgeon-reported outcomes met the minimal level of feasibility in all procedures and a consensus that it is feasible to perform TORS with Versius was reached. Available instrumentation was not representative of other robotic platforms used in TORS and further instrument optimisation is recommended before wider dissemination. Conclusions: It is feasible to perform TORS with the Versius Surgical System (CMR Surgical) within a pre-clinical cadaveric setting. Clinical evaluation is needed and appropriate with the system. Further instrument development and optimisation is desirable.

Robotic assisted orbital surgery for resection of advanced periocular tumours - a case series report on the feasibility, safety and outcome.

PURPOSE: Orbital surgery benefits from well-designed instrumentation that offers gentle tissue manipulation, high manoeuvrability and control. Nevertheless, in confined spaces, tissue manipulation must be accomplished with exceptionally high accuracy and precision. This is where robotic surgery offers an advantage. We aimed to evaluate a robotic-assisted surgical system's feasibility, safety and outcome in assisting tumour clearance. PATIENTS AND METHODS: A case series of patients with advanced periocular tumours undergoing robotic-assisted globe-sparing resection was performed using the DaVinci XI system (Intuitive Surgical, Inc). Institutional ethics and multidisciplinary approval were sought in all cases. RESULTS: Four patients with advanced periocular tumours underwent robotic-assisted orbital surgery at a mean age of 63 years (range 42-86). Two patients were diagnosed with squamous cell carcinoma, and two had basal cell carcinoma. One patient was found to have positive lymph nodes at the time of surgery and underwent simultaneous parotidectomy and lymph node clearance. Clear resection of the primary tumour was achieved in all patients; three patients underwent further resection due to narrow margins prior to reconstruction. Patients were follow-up for at least one year, and three remained disease-free. One patient with pre-existing extra-orbital disease developed metastatic disease four months post-op. All patients preserved vision peri-operatively, with no complaints of diplopia. Moderate ocular surface disease was noted in two patients. CONCLUSION: Our series highlights the potential advantage of three-dimensional optics, multi-directional instrumentation and motion scaling technology to achieve globe-sparing tumour resection in advanced periocular tumours. However, further robotic instrumentation development is required for orbital surgery.

Soft Tissue Robotic Assisted Orbital Surgery Using da Vinci SP: A Cadaveric Experience.

PURPOSE: Robotic surgical techniques have transformed many surgical specialties however robotic techniques and applications have been much more limited in ophthalmology. This study aims to evaluate the feasibility of robotic assisted orbital surgery using a single-port novel robotic platform, the da Vinci SP. METHODS: A series of orbital procedures were performed in cadaveric specimens utilizing the da Vinci SP robotic system. The procedures performed included lacrimal gland dissection and biopsy, medial and lateral orbital wall dissections, enucleation, and lid-sparing orbital exenteration. Successful completion of each procedure was defined by the operating surgeon and was considered the primary outcome and marker of feasibility. RESULTS: Seven cadaveric procedures were performed in 3 cadaveric specimens. All 7 procedures were completed successfully without complication. Setup optimization occurred throughout the study and setup and operative times were acceptable. Three instrument arms and 1 endoscope were utilized throughout the study allowing 3 arm operating and dynamic retraction. Instrument size was found to limit surgical access and precision particular at the orbital apex. CONCLUSIONS: This preclinical study demonstrates that the da Vinci SP can be utilized within the orbit and is feasible for several applications. Robotic surgical systems offer significant advantages over conventional techniques and should be embraced. However, current commercially available robotic platforms are not optimized for the orbit and have their limitations although they may be suitable for some clinical applications.

Water soluble swallow for leak detection after total laryngectomy post radiotherapy.

AIM: Pharyngeal leak (PL) and pharyngocutaneous fistula (PCF) are serious complications following total laryngectomy and their incidence is higher in the salvage setting. The aim of this study is to describe the accuracy of water soluble swallow (WSS) to rule out salivary postoperative leak after salvage total laryngectomy (STL) to expedite start of oral intake. MATERIAL AND METHODS: Retrospective study including patients undergoing STL between 2008 and 2021 at Guy's Hospital. WSS was routinely performed within 15 days post operation. RESULTS: Sixty-six patients underwent STL. Nine developed clinically diagnosed PCF; one died before having WSS. Fifty-six patients underwent WSS post STL. WSS was performed within 15 days after STL when no postoperative complications occurred (76.8%). Among patients undergoing WSS with no clinical suspicion for fistula (56), PL was identified in 15 cases (26.8%). They were managed conservatively; PCF was avoided in 7(46.7%) cases. Three patients (7.3%) developed PCF after having started oral intake with a negative WSS. These three cases were further analysed, 2 cases where recorded at the beginning of the studied period when less experience was available possibly leading to incorrect results. Sensitivity and negative predictive value (NPV) for fistula prediction were 72.7% and 92.7%, respectively. CONCLUSION: Taking into account the high NPV of WSS, it is safe to start oral intake after negative WSS. Further studies to evaluate its accuracy earlier on after SLT are justified taking into account the results and the impact that delayed feeding has on patient's quality of life.

Neck Dissection Timing in Transoral Robotic or Laser Microsurgery in Oropharyngeal Cancer: A Systematic Review.

Objective: This review assesses the effect on intra- and postoperative patient outcomes of the timing of neck dissection in relation to transoral surgery. Outcome measures include postoperative bleeding, intra- and postoperative fistula formation, and disease-specific and overall survival. Data Sources: A search was conducted across the MEDLINE, Embase, US National Library of Medicine, and Cochrane databases with search terms in July 2021. Review Methods: Articles that conformed with specified inclusion criteria were included. Included articles were scanned for bias with the ROBINS-I tool. Results: Nineteen articles were selected for qualitative analysis, including 546 patients who had neck dissection in conjunction with transoral robotic surgery/transoral laser microsurgery (TORS/TLM). Seventy-one (18%) patients had neck dissection prior to TORS/TLM, 39 (10%) had neck dissection performed after TORS/TLM, and 281 (72%) had concurrent procedures. In patients with neck dissection before TORS/TLM, 3% experienced major postoperative bleeding, and fistula rates were 0%. In the cohort with neck dissection after TORS/TLM, 3% experienced minor postoperative hemorrhage, and 8% had intraoperative fistulae. In the concurrent cohort of patients, 1% had major postoperative bleeds and 0.3% had minor bleeds, while 4% developed intraoperative fistulas and 0.3% developed postoperative fistulas. Conclusion: Current evidence indicated that there appears to be no correlation between timing of neck dissection and complications. This systematic review found insufficient data to comment on whether the timing of neck dissection in relation to TORS/TLM affects the outcomes of patients.

Reducing the unknowns: A systematic review & meta-analysis of the effectiveness of trans-oral surgical techniques in identifying head and neck primary cancer in carcinoma unknown primary.

OBJECTIVES: The use of transoral robotic surgery (TORS), transoral laser microsurgery (TLM) and more recently reported transoral endoscopic electrocautery (TOEC) in identifying the primary cancer in head and neck Carcinoma Unknown Primary (CUP) patients have gained popularity. This review aims to assess the effectiveness of TORS, TLM and TOEC. MATERIALS & METHODS: A systematic review and meta-analysis was carried out. EMBASE, MEDLINE and CINAHL databases were searched from inception to September 2020. All primary studies were considered for inclusion. Primary outcome measure was detection rates of primary cancer of the different techniques. Secondary outcome measures were complications and length of hospital stay. RESULTS: 289 studies were identified of which 30 met the inclusion criteria. The primary cancer was identified in 567 /777 patients (pooled results was 64% (95% CI 54-73). The primary identification rates were 45% and 32% in lingual (n = 273) and palatine tonsillectomy (n = 118) respectively. The primary cancer identification rates by surgical techniques are: TORS was 60% (95% CI 49-70), TLM was 80% (95% CI 0.58, 1.01), TOEC was 41% (95% CI 0.05, 0.76). 529/777 (68%) tumours were Human Papilloma Virus (HPV) related. The pooled data of studies that reported on detection rates relating to HPV status were 178/216 (82%) for HPV +ve and 7/59 (12%) for HPV -ve tumours. Coefficient of variation results suggest heterogenous data for TORS and TLM. The commonest complication was haemorrhage (5.3%). The length of reported hospital stay ranged from 1.4 to 7 days. CONCLUSIONS: This is the largest systematic review in the subject. The quality of studies and heterogeneity of data limit conclusive findings. Lingual tonsillectomy is an effective procedure in CUP work up. Further larger, multicentre, prospective studies of PET CT negative CUP patients is needed to draw conclusive results.

Outcomes of head and neck cancer management from two cancer centres in Southern and Northern Europe during the first wave of COVID-19.

OBJECTIVE: To describe the approach and outcomes from two cancer centres in Southern and Northern Europe during the first wave of coronavirus disease 2019 (COVID-19) of patients with head and neck cancer (HNC). METHODS: Data collection was performed on a retrospective cohort of patients surgically treated for primary HNC between March and May 2020, using data from two tertiary hospitals: the European Institute of Oncology (Milan) and Guy's & St Thomas' NHS Foundation Trust (London). RESULTS: We included 77 patients with HNC. More patients with COVID-19 were taking angiotensin-converting enzyme (ACE) inhibitors and had Clavien-Dindo Classification grade I compared to negative patients, respectively (60% vs 22% [p = 0.058] and 40% vs 8% [p = 0.025]). Multivariate logistic regression analyses confirmed our data (p = 0.05 and 0.03, respectively). Sex and age were statistically significantly different (p = 0.05 and <0.001 respectively), showing more male patients (75% vs 53.66%, respectively) and more elderly patients in Italy than in the United Kingdom (patients aged >63 years: 69.44% vs 29.27%). CONCLUSIONS: This study presents a large cohort of patients with HNC with nasopharyngeal swab during the first peak of the COVID-19 pandemic in Europe. Patients with HNC with COVID-19 appeared more likely to develop postsurgical complications and to be taking ACE inhibitors. The preventive measures adopted guaranteed the continuation of therapeutic surgical intervention.

Role of Thyroidectomy in Recurrent Laryngeal Carcinoma.

OBJECTIVE: Management of recurrent laryngeal cancer presents a major challenge, and salvage laryngectomy is complicated by previous oncologic treatments. Thyroidectomy as part of salvage laryngectomy adds a nonnegligible degree of morbidity. The purpose of this study is to assess the rate of thyroid gland invasion in patients undergoing salvage laryngectomy to determine relevant predictive factors. STUDY DESIGN: Case series with chart review. SETTING: Department of Otorhinolaryngology, Head and Neck Surgery, Guy's Hospital, London, United Kingdom. METHODS: A retrospective review of patients undergoing salvage laryngectomy between 2009 and 2019 was undertaken. Preoperative cross-sectional imaging and histopathological analysis were performed to define evidence and predictors of thyroid gland invasion (TGI). RESULTS: Fifty-one patients had salvage laryngectomy. Histological evidence of TGI was found in 4 patients (7.8%). No significant relationship was found between histological TGI and subsite of primary carcinoma, degree of differentiation, T staging, or radiological TGI. Preoperative computed tomography had a high negative predictive value for TGI. CONCLUSION: Thyroidectomy should be carefully considered in patients undergoing salvage laryngectomy, and its extent should be defined on an individual basis. Total thyroidectomy should not routinely be performed in salvage laryngectomy or pharyngolaryngectomy in patients with no preoperative radiological evidence of TGI on cross-sectional imaging, unless there is intraoperative evidence of TGI.

Management of Obscurely Dilated Common Bile Duct with Normal Liver Function Tests: A Pragmatic Approach.

OBJECTIVE: Dilated common bile duct (CBD) (8-15 mm) with normal liver function tests is seen not infrequently, while management of such patients is ambiguous. We propose a treatment algorithm for this cohort of patients after observing them over a period of 8 years. METHODS: Seventy-eight such patients were managed from 2009 to 2017 and categorized as: Group A-dilated CBD with post-cholecystectomy status (n = 15); B-dilated CBD with cholelithiasis (n = 34); C-dilated CBD without cholelithiasis (n = 16); D-dilated CBD with no cause identified and underwent CBD excision (n = 13). Causes for CBD dilatation were evaluated. The outcome of patients in Group B + C without any cause (n = 33) was compared with Group D. RESULT: Median age, CBD diameter, bilirubin and alkaline phosphatase were 51 years (13-79), 10 mm (8-20), 0.6 mg/dl (0.2-2.5) and 126 IU (60-214), respectively. Group-A patients who did not manifest any cause of CBD dilatation were managed conservatively. The aetiology was identified in 17/50 patients in Group B & C [acute pancreatitis (n = 6), passed CBD calculi (n = 3), perivaterian diverticulum (n = 3), viral aetiology (n = 4) and tumour (n-1)]. In Group-C, 7 patients with no obvious cause underwent endoscopic sphincterotomy, pancreatoduodenectomy (n = 1), and the rest were managed conservatively (n = 8). There was no significant difference in the complication between Group B + C (without any cause) and Group D (3/33 vs. 1/13; p = 0.58) at a median follow-up of 72 months (30-90). CONCLUSION: Dilated CBD with normal LFT's without apparent cause is mostly benign and of no consequence. Excision of the CBD is not required for most of these patients.

Strategic approach to minimally invasive necrosectomy for necrotizing pancreatitis: technique, complications and predictors of outcome.

BACKGROUND: Minimally invasive retroperitoneal necrosectomy has been an integral component of 'step-up' approach for infected pancreatic necrosis. Even though the clinical outcome of nephroscopic necrosectomy has been studied earlier, its predictor and morbidities following surgery have not been extensively evaluated. We aimed to evaluate the clinical outcome and early and late complications after percutaneous nephroscopic necrosectomy (PCNN). METHODS: The pre- and intra-operative as well as post-operative and follow-up data of severe pancreatitis patients undergoing PCNN were collected prospectively. RESULTS: Out of 115 patients requiring intervention, 40 patients (34.78%) improved with percutaneous drain alone and another 40 proceeded for PCNN. After exclusion, 37 patients successfully underwent 48 sessions of PCNN. Median number of PCNN session was 1 (1-4). Early complications were seen in 21 (56.75%) patients and mortality was experienced in eight (21.62%) patients. On median follow-up of 36 months, 12 (32.43%) patients experienced late complications. Persistent post-operative pancreatic fistula was observed in six (16.21%) patients. Of these, three developed late-onset pseudocyst, whereas one patient had disconnected duct syndrome. Seven patients experienced new-onset diabetes. Age, severity of pancreatitis, preoperative organ failure and multiorgan failure were significant predictors of mortality on univariate analysis (P ≤ 0.05 for each). The logistic regression analysis revealed presence of multiorgan failure before surgery as the sole predictor (P = 0.007; odds ratio 10.417; 95% confidence interval 1.759-61.672). CONCLUSION: Preoperative multiorgan failure was the most important predictor of mortality following PCNN. Late complications were seen in nearly one-third of patients emphasizing the need for long-term follow-up.

Open versus percutaneous tracheostomy in COVID-19: a multicentre comparison and recommendation for future resource utilisation.

PURPOSE: The COVID-19 pandemic placed an unprecedented demand on critical care services for the provision of mechanical ventilation. Tracheostomy formation facilitates liberation from mechanical ventilation with advantages for both the patient and wider critical care resource, and can be performed using both percutaneous dilatational and surgical techniques. We compared outcomes in those patients undergoing percutaneous dilatational tracheostomy to those undergoing surgical tracheostomy and make recommendations for provision of tracheostomy services in any future surge. METHODS: Multicentre multidisciplinary retrospective observational cohort study including 201 patients with COVID-19 pneumonitis admitted to an ICU in one of five NHS Trusts within the South London Adult Critical Care Network who required mechanical ventilation and subsequent tracheostomy. RESULTS: Percutaneous dilatational tracheostomy was performed in 124 (62%) of patients, and surgical tracheostomy in 77 (38%) of patients. There was no difference between percutaneous dilatational tracheostomy and surgical tracheostomy in either the rate of peri-operative complications (16.9 vs. 22.1%, p = 0.46), median [IQR(range)] time to decannulation [19.0 (15.0-30.2 (5.0-65.0)] vs. 21.0 [15.5-36.0 (5.0-70.0) days] or mortality (13.7% vs. 15.6%, p = 0.84). Of the 172 patients that were alive at follow-up, two remained ventilated and 163 were decannulated. CONCLUSION: In patients with COVID-19 pneumonitis that require tracheostomy to facilitate weaning from mechanical ventilation, there was no difference in outcomes between those patients that had percutaneous dilatational tracheostomy compared with those that had surgical tracheostomy. Planning for future surges in COVID-19-related critical care demands should utilise all available resource and expertise.

Tracheostomy care and decannulation during the COVID-19 pandemic. A multidisciplinary clinical practice guideline.

PURPOSE: Traditional critical care dogma regarding the benefits of early tracheostomy during invasive ventilation has had to be revisited due to the risk of COVID-19 to patients and healthcare staff. Standard practises that have evolved to minimise the risks associated with tracheostomy must be comprehensively reviewed in light of the numerous potential episodes for aerosol generating procedures. We meet the urgent need for safe practise standards by presenting the experience of two major London teaching hospitals, and synthesise our findings into an evidence-based guideline for multidisciplinary care of the tracheostomy patient. METHODS: This is a narrative review presenting the extensive experience of over 120 patients with tracheostomy, with a pragmatic analysis of currently available evidence for safe tracheostomy care in COVID-19 patients. RESULTS: Tracheostomy care involves many potentially aerosol generating procedures which may pose a risk of viral transmission to staff and patients. We make a series of recommendations to ameliorate this risk through infection control strategies, equipment modification, and individualised decannulation protocols. In addition, we discuss the multidisciplinary collaboration that is absolutely fundamental to safe and effective practise. CONCLUSION: COVID-19 requires a radical rethink of many tenets of tracheostomy care, and controversy continues to exist regarding the optimal techniques to minimise risk to patients and healthcare workers. Safe practise requires a coordinated multidisciplinary team approach to infection control, weaning and decannulation, with integrated processes for continuous prospective data collection and audit.

Laparoscopic cholecystectomy in patients with portal cavernoma without portal vein decompression.

INTRODUCTION: Laparoscopic cholecystectomy (LC) in patients with extrahepatic portal vein obstruction causing portal cavernoma (PC) is considered high risk because of portosystemic collateral veins in the hepatocystic triangle. The literature is limited to isolated case reports. We describe our experience of LC in patients with PC. PATIENTS AND METHODS: Data of patients with PC who underwent LC for symptomatic gallstones or related complications was reviewed. Patients with simultaneous cholecystectomy with splenorenal shunt and open cholecystectomy were excluded. Pre-operative evaluation consisted of complete blood count, international normalisation ratio and liver function tests, ultrasound of the abdomen with Doppler, contrast-enhanced computerised tomography, magnetic resonance cholangiopancreatography and esophagogastroscopy as indicated. A standard four-port LC was performed. The technical principles followed were to avoid injury to the collateral veins, liberal use of energy sources and division of dominant collateral veins between clips. RESULTS: Seven adult patients including three females underwent LC. Three patients had thrombosis of previous surgical shunt with persistent PC. The remaining four patients did not have any indication for shunt surgery. Successful LC was performed in six patients. The median duration of surgery was 170 (130-250 min). Blood transfusion was not required. All the patients had uneventful post-operative recovery. The histopathology of gall bladder consists of acute cholecystitis in three patients and chronic cholecystitis in four. CONCLUSION: LC is feasible in patients with PC at a centre with experience in both laparoscopic and portal hypertension surgeries. Excellent outcome with low rate of conversion to open surgery can be achieved.

Multidisciplinary Tracheostomy Quality Improvement in the COVID-19 Pandemic: Building a Global Learning Community.

OBJECTIVES: To report experience with a global multidisciplinary tracheostomy e-learning initiative. METHODS: An international multidisciplinary panel of experts convened to build a virtual learning community for tracheostomy care, comprising a web-based platform, five distance learning (interactive webinar) sessions, and professional discourse over 12 months. Structured pre- and post-webinar surveys were disseminated to global participants including otolaryngologists, intensivists, nurses, allied health professionals, and patients/caregivers. Data were collected on audio-visual fidelity, demographics, and pre- and post-tutorial assessments regarding experience and skill acquisition. Participants reported confidence levels for NICU, pediatric, adult, and family care, as well as technical skills, communication, learning, assessment, and subdomains. RESULTS: Participants from 197 institutions in 22 countries engaged in the virtual education platform, including otolaryngologists, speech pathologists, respiratory therapists, specialist nurses, patients, and caregivers. Significant improvements were reported in communication (P < .0001), clinical assessments (P < .0001), and clinical governance (P < .0001), with positive impact on pediatric decannulation (P = .0008), adult decannulation (P = .04), and quality improvement (P < .0001). Respondents reported enhanced readiness to integrate knowledge into practice. Barriers included time zones, internet bandwidth, and perceived difficulty of direct clinical translation of highly technical skills. Participants rated the implementation highly in terms of length, ability for discussion, satisfaction, applicability to professional practice, and expertise of discussants (median scores: 4, 4, 4, 4 and 5 out of 5). CONCLUSIONS: Virtual learning has dominated the education landscape during COVID-19 pandemic, but few data are available on its effectiveness. This study demonstrated feasibility of virtual learning for disseminating best practices in tracheostomy, engaging a diverse, multidisciplinary audience. Learning of complex technical skills proved a hurdle, however, suggesting need for hands-on experience for technical mastery. While interactive videoconferencing via webinar affords an engaging and scalable strategy for sharing knowledge, further investigation is needed on clinical outcomes to define effective strategies for experiential online learning and virtual in-service simulations.

Tracheostomy, ventilatory wean, and decannulation in COVID-19 patients.

PURPOSE: COVID-19 patients requiring mechanical ventilation can overwhelm existing bed capacity. We aimed to better understand the factors that influence the trajectory of tracheostomy care in this population to facilitate capacity planning and improve outcomes. METHODS: We conducted an observational cohort study of patients in a high-volume centre in the worst-affected region of the UK including all patients that underwent tracheostomy for COVID-19 pneumonitis ventilatory wean from 1st March 2020 to 10th May 2020. The primary outcome was time from insertion to decannulation. The analysis utilised Cox regression to account for patients that are still progressing through their tracheostomy pathway. RESULTS: At the point of analysis, a median 21 days (IQR 15-28) post-tracheostomy and 39 days (IQR 32-45) post-intubation, 35/69 (57.4%) patients had been decannulated a median of 17 days (IQR 12-20.5) post-insertion. The overall median age was 55 (IQR 48-61) with a male-to-female ratio of 2:1. In Cox regression analysis, FiO2 at tracheostomy ≥ 0.4 (HR 1.80; 95% CI 0.89-3.60; p = 0.048) and last pre-tracheostomy peak cough flow (HR 2.27; 95% CI 1.78-4.45; p = 0.001) were independent variables associated with prolonged time to decannulation. CONCLUSION: Higher FiO2 at tracheostomy and higher pre-tracheostomy peak cough flow are associated with increased delay in COVID-19 tracheostomy patient decannulation. These finding comprise the most comprehensive report of COVID-19 tracheostomy decannulation to date and will assist service planning for future peaks of this pandemic.

Timing of Tracheostomy for Prolonged Respiratory Wean in Critically Ill Coronavirus Disease 2019 Patients: A Machine Learning Approach.

OBJECTIVES: To propose the optimal timing to consider tracheostomy insertion for weaning of mechanically ventilated patients recovering from coronavirus disease 2019 pneumonia. We investigated the relationship between duration of mechanical ventilation prior to tracheostomy insertion and in-hospital mortality. In addition, we present a machine learning approach to facilitate decision-making. DESIGN: Prospective cohort study. SETTING: Guy's & St Thomas' Hospital, London, United Kingdom. PATIENTS: Consecutive patients admitted with acute respiratory failure secondary to coronavirus disease 2019 requiring mechanical ventilation between March 3, 2020, and May 5, 2020. INTERVENTIONS: Baseline characteristics and temporal trends in markers of disease severity were prospectively recorded. Tracheostomy was performed for anticipated prolonged ventilatory wean when levels of respiratory support were favorable. Decision tree was constructed using C4.5 algorithm, and its classification performance has been evaluated by a leave-one-out cross-validation technique. MEASUREMENTS AND MAIN RESULTS: One-hundred seventy-six patients required mechanical ventilation for acute respiratory failure, of which 87 patients (49.4%) underwent tracheostomy. We identified that optimal timing for tracheostomy insertion is between day 13 and day 17. Presence of fibrosis on CT scan (odds ratio, 13.26; 95% CI [3.61-48.91]; p ≤ 0.0001) and Pao2:Fio2 ratio (odds ratio, 0.98; 95% CI [0.95-0.99]; p = 0.008) were independently associated with tracheostomy insertion. Cox multiple regression analysis showed that chronic obstructive pulmonary disease (hazard ratio, 6.56; 95% CI [1.04-41.59]; p = 0.046), ischemic heart disease (hazard ratio, 4.62; 95% CI [1.19-17.87]; p = 0.027), positive end-expiratory pressure (hazard ratio, 1.26; 95% CI [1.02-1.57]; p = 0.034), Pao2:Fio2 ratio (hazard ratio, 0.98; 95% CI [0.97-0.99]; p = 0.003), and C-reactive protein (hazard ratio, 1.01; 95% CI [1-1.01]; p = 0.005) were independent late predictors of in-hospital mortality. CONCLUSIONS: We propose that the optimal window for consideration of tracheostomy for ventilatory weaning is between day 13 and 17. Late predictors of mortality may serve as adverse factors when considering tracheostomy, and our decision tree provides a degree of decision support for clinicians.