COVIDTrach; a prospective cohort study of mechanically ventilated COVID-19 patients undergoing tracheostomy in the UK

COVIDTrach collaborative, NJI Hamilton,AGM Schilder, T Jacob,G Ambler,M Singer,MM George, F Green,R Vasanthan, J Goulder,E Jackson, A Arora, N Kumar, C Schilling, S Laha,I Ahmad,B McGrath, MA Birchall,NS Tolley,G Sandhu,T Tatla,N Sharma, P Stimpson, P Andrews, N Mercer,P Nankivell,O Breik, P Praveen, M Idle, T Martin, S Parmar, P Pracy, C Jennings, J Higginson, K Fan, E Yeung, J Osher, R Bentley, C Huppa, P Stenhouse, K Hussain, S Hodges, F Ryba,P Surda,EK Bhargava, N Amin, J Collins, M Kelly, D Ranford, A Takhar, C Tornari, M Verkerk, C Xie, D Pennell, C Al-Yaghchi,L Ritchie, M Jaafar, M Rouhani, M Ashcroft, N Cereceda-Monteoliva, A Holroyd, J Ng, R Mistry, K Ghufoor,E Warner, H O’Mahony, S Shepherd,N Bhatti, H Drewery, J Hadley, A Mulcahy, H Wilson,R Bhandari,M Griffiths, T Magos, I Balasundaram, M Heliotis, A Loizidou, D York, R Exley, KA Solanki, P Shah, P Kirticumar, A Shah, S Shannon, A Shirazian, Y Bhatt, K Dhadwal,GM Jama, Z Abdi, T Exall, I Ekpemi, R Roplekar-Bance, C Walker, N Glibbery, K Karamali, A Li,A Rovira, D Dawson, T Munroe-Gray, P Sethukumar,J Phillips, A Williamson, R Saha, M Roberts, H Lee-Six, B Misztal, S Millington, M Musalia,S Suresh, A Cardozo, M Dunbobbin, A Tse, S Shahidi, M Chachlani, K Jolly, J Fussey, M Misurati, M Osborne, S Ashok, H Aboulgheit, S Khwaja, R Anmolsingh, C Smyth, B Al-Dulaimy,E Omakobia, J Collier, T Browning,A Courtney, P Ward, L Lignos, C Lockie, P Twose, J Heyman, S Berry, P Bishop, D Kathwadia, T Hwara, A Williamson, A Kumar,O Judd, W Parker, TP Davis, T Stubington, T Ali, A Schache, H Koumoullis, E Willcocks, L Skeely, G Dempsey,K Liatsikos, B Borgatta, J Rodrigues,A Glossop, J Sen, N Lawrence,S Bennett, L Wren, V Politidis, D Dhariwal,S Winter, A Kara, T Hunt, G Tattersall, W Udall,B Hill, S Saha, L Bates, C Smart, D Park, R O’Brien, L Linhartova, P Kirkland, J Staufenberg,K Valchanov, H Buglass, U Sheikh, E Tam, J Williamson, A McGrath, S Siddiq, NW Wahid, H Griffiths, M De, A Amlani, P Deutsch, K Markham, C Hall, S Webster, O Barker, P Sykes, A Gupta, A Easthope, S Glaze, B Morris, D Bondin, D Thorley, K Kapoor, S Sirajuddin, S Fang, F van Damme, O Mattoo, E Paramasivam, E Kershaw, S Dewhurst, S Blakeley,C Chivers, L Lindsey, DJ Lin, A Burns, A Wilson, N Macartney, F Franco, K Goodwin, B Cosway, R Glore, H Cunniffe, M Keil, S Burrows, D Moult, D Zolger, J Bakmanidis, D Nair, S Kandiah,M Anwar, A Pericleous,C Hogan, R Temple,D Whitmore, R Sheikh, R Pinto, C Cook, J Broad, U Nagalotimath, E El-Tabal, S Ghaffar, M Dallison, E Leakey, R Harris, J Blair, E France, O Sanders, P Mukherjee,A Gomati, L Moir, CB Groba, C Davies-Husband, N Seymour,S Mahalingam, D Williams, R Lovett, J Lunn, A Armson, A Balfour, K Steele, K Hilliard, S Ladan,P Paul, P Tsirevelou, V Ratnam, H Turner, N Jain, A Muddaiah, M Celinski, J Smith, J Westwood, J Coakes, R Borg, J McEwan,A Tsagkovits, O Mulla, N Stobbs, G Warner, D Pratap, Z Ghani,J Rocke, S Snape, S Ghosh, A Hassaan,M Cameron, A Daudia, S Menon, S Beckett, R Siau, A Howard, C Lamont, C Blore, C Pearce, D Zakai, S Biswas, R Moorthy, J Bates, P Gill, E Riley, P Bothma, S Meghji, W Rutherford, A Lloyd, A Syndercombe, P Smith, N Keates, V Srinivasan, M Junaid, M Kumar, T Antonio,A Vijendren, V Venkatachalam, I Gonzalez,M Lechner, D Chandrasekharan, A Arya, R Brown,H Jones, D Kumar,R Sykes, B Tehan, A Walker, J Whiteside,F Cooper, A Coombs,G Wong, D Walker, S Dennis, A Hormis, A Eldahshan, L Leach, H Paw, M Colomo-Gonzalez, D Chakravarty, S Sanyal, N Mani, B Ranganathan, H Saeed, S Linton, A Thompson, J Whittaker, N Amiruddin, A Sladkowsk, R Gohil,AK Abou-Foul, J Ahmed, S Kishwan, G Walton, P Naredla, A Al-Ajami, S Wilkinson, S Okhovat, A Menon, S Mustafa,E Carey, N Vallabh, T Davies, A. Alatsatianos, R Townsley

medrxiv（2020）

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摘要

Purpose COVIDTrach is a UK multi-centre prospective cohort study project evaluating the outcomes of tracheostomy in patients with COVID-19 receiving mechanical ventilation. It also examines the incidence of SARS-CoV-2 infection among healthcare workers involved in the procedure. Method An invitation to participate was sent to all UK NHS departments involved in tracheostomy in COVID-19 patients. Data was entered prospectively and clinical outcomes updated via an online database (REDCap). Clinical variables were compared with outcomes using multivariable regression analysis, with logistic regression used to develop a prediction model for mortality. Participants recorded whether any operators tested positive for SARS-CoV-2 within two weeks of the procedure. Results The cohort comprised 1605 tracheostomy cases from 126 UK hospitals. The median time from intubation to tracheostomy was 15 days (IQR 11, 21). 285 (18%) patients died following the procedure. 1229 (93%) of the survivors had been successfully weaned from mechanical ventilation at censoring and 1049 (81%) had been discharged from hospital. Age, inspired oxygen concentration, PEEP setting, pyrexia, number of days of ventilation before tracheostomy, C-reactive protein and the use of anticoagulation and inotropic support independently predicted mortality. Six reports were received of operators testing positive for SARS-CoV-2 within two weeks of the procedure. Conclusions Tracheostomy appears to be safe in mechanically ventilated patients with COVID-19 and to operators performing the procedure and we identified clinical indicators that are predictive of mortality. Funding The COVIDTrach project is supported by the Wellcome Trust UCL COVID-19 Rapid Response Award and the National Institute for Health Research. Trial registration The study is registered with [ClinicalTrials.Gov][1] ([NCT04572438][2]). ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial NCT04572438 ### Funding Statement COVIDTrach is supported by the Wellcome Trust UCL COVID-19 Rapid Response award and the NIHR Clinical Research Network. Nick Hamilton is an NIHR Clinical Lecturer and is supported by the Royal College of Surgeons (Eng) and the Academy of Medical Sciences. Anne GM Schilder is an NIHR Senior Investigator and Director of the NIHR UCLH BRC Hearing Theme; the research of her UCL Ear Institute evidENT team is supported by the National Institute for Health Research (BRC, ARC, CRN, PGfAR, RfPB), Wellcome Trust, RCSEng, and EU Horizon2020. Martin Birchall is an NIHR Senior Investigator. Data collection through BAOMS was managed by Fabien Puglia and supported by NFORC and Saving faces. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Health Research Authority (20/HRA/3766) All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes The authors confirm that the data supporting the findings of this study are available within the article and its supplementary materials [1]: http://ClinicalTrials.Gov [2]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT04572438&atom=%2Fmedrxiv%2Fearly%2F2020%2F11%2F30%2F2020.10.20.20216085.atom

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tracheostomy,patients

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