Percutaneous dilatational tracheostomy with single use bronchoscopes versus reusable bronchoscopes - a prospective randomized trial (TraSUB)

Pischtaz Adel Tariparast, Andrés Brockmann, Rainer Hartwig, Stefan Kluge, Jörn Grensemann, Pischtaz Adel Tariparast, Andrés Brockmann, Rainer Hartwig, Stefan Kluge, Jörn Grensemann

Abstract

Background: Apart from conventional reusable bronchoscopes, single-use bronchoscopes (SUB) were recently introduced. Data suggest that SUB might prevent from the risk of cross contamination (i.e. multiresistant pathogens, SARS CoV-2) and save costs. We aimed to investigate visualization, ventilation, handling characteristics, changes in patients' gas exchange, and costs associated with both types of bronchoscopes during percutaneous dilatational tracheostomy (PDT).

Methods: In this prospective, randomized, noninferiority study, 46 patients undergoing PDT were randomized 1:1 to PDT with SUB (Ambu aScope) or reusable bronchoscopes (CONV, Olympus BF-P60). Visualization of tracheal structures rated on 4-point Likert scales was the primary end-point. Furthermore, quality of ventilation, device handling characteristics, changes in the patients' gas exchange, pH values, and costs were assessed.

Results: Noninferiority for visualization (the primary endpoint) was demonstrated for the SUB group. Mean visualization scores (lower values better) were 4.1 (95% confidence intervals: 3.9;4.3) for SUB vs. 4.1 (4.0;4.2) for CONV. Noninferiority of ventilation (estimated by minute volume and SpO2) during the procedure could be shown as well. Mean score was 2.6 (2.0;3.1) for SUB vs. 2.4 (2.1;2.7) for CONV (lower values better). No significant differences regarding handling (SUB: 1.2 (1.0;1.4), CONV: 1.3 (1.1;1.6)), blood gas analyses and respiratory variables were found. Cost analysis in our institution revealed 93 € per conventional bronchoscopy versus 232.50 € with SUB, not considering an estimate for possible infection due to cross-contamination with the reusable device.

Conclusion: In our study, visualization and overall performance of the SUB during PDT were noninferior to reusable bronchoscopes. Therefore, PDT with SUB is feasible and should be considered if favored by individual institution's cost analysis.

Trial registration: ClinicalTrials.gov, NCT03952247 . Submitted for registration on 28/04/2019 and first posted on 16/05/2019.

Conflict of interest statement

PAT and AB have received study support from Ambu; RH reports no conflicts of interest; SK received research support from Ambu, Daiichi Sankyo, ETView Ltd, Fisher & Paykel and Xenios. He also received lecture fees from Astra, C.R.Bard, Baxter, Biotest, Cytosorbents, Fresenius, Gilead, MSD, Pfizer, Philips and Zoll. He received consultant fees from Bayer, Fresenius, Gilead, MSD and Pfizer; JG has received research support from Infectopharm, Pfizer, Ambu, Adroit Surgical, and ETView, and consultant fees from Fresenius Medical Care, Smith Medical, Drägerwerk, and GE Healthcare.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Consolidated Standards of Reporting Trials (CONSORT) diagram
Fig. 2
Fig. 2
Rating of ventilation, handling, and visualization according to score. Lower scores indicate better performance. Error bars indicate 95% confidence intervals

References

    1. Panchabhai TS, Mehta AC. Historical perspectives of bronchoscopy. Connecting the dots. Annals Amer Thora Soc. 2015;12(5):631–641. doi: 10.1513/AnnalsATS.201502-089PS.
    1. Mouritsen JM, Ehlers L, Kovaleva J, Ahmad I, El-Boghdadly K. A systematic review and cost effectiveness analysis of reusable vs. single-use flexible bronchoscopes. Anaesthesia. 2020;75(4):529–540. doi: 10.1111/anae.14891.
    1. Terjesen CL, Kovaleva J, Ehlers L. Early Assessment of the Likely Cost Effectiveness of Single-Use Flexible Video Bronchoscopes. Pharmacoecon Open. 2017;1(2):133–141. doi: 10.1007/s41669-017-0012-9.
    1. Zaidi SR, Collins AM, Mitsi E, Reiné J, Davies K, Wright AD, Owugha J, Fitzgerald R, Ganguli A, Gordon SB, et al. Single use and conventional bronchoscopes for Broncho alveolar lavage (BAL) in research: a comparative study (NCT 02515591) BMC Pulm Med. 2017;17(1):83. doi: 10.1186/s12890-017-0421-7.
    1. Honore PM, Mugisha A, Kugener L, Redant S, Attou R, Gallerani A, De Bels D. With the current COVID pandemic: should we use single-use flexible bronchoscopes instead of conventional bronchoscopes? Crit Care. 2020;24(1):234. doi: 10.1186/s13054-020-02965-9.
    1. Grensemann J, Simon M, Kluge S. Airway management in intensive care and emergency medicine: What is new? Med Klin Intensivmed Notfmed. 2019;114(4):334–341. doi: 10.1007/s00063-018-0498-7.
    1. Vargas M, Sutherasan Y, Antonelli M, Brunetti I, Corcione A, Laffey JG, Putensen C, Servillo G, Pelosi P. Tracheostomy procedures in the intensive care unit: an international survey. Crit Care. 2015;19:291. doi: 10.1186/s13054-015-1013-7.
    1. Simon M, Metschke M, Braune SA, Puschel K, Kluge S. Death after percutaneous dilatational tracheostomy: a systematic review and analysis of risk factors. Crit Care. 2013;17(5):R258. doi: 10.1186/cc13085.
    1. Eichler L, Simon M, Kluge S. Tracheal laceration after dilatational tracheostomy : A case of succesful conservative management. Med Klin Intensivmed Notfmed. 2017;112(7):629–631. doi: 10.1007/s00063-016-0255-8.
    1. Kluge S, Baumann HJ, Maier C, Klose H, Meyer A, Nierhaus A, Kreymann G. Tracheostomy in the intensive care unit: a nationwide survey. Anesth Analg. 2008;107(5):1639–1643. doi: 10.1213/ane.0b013e318188b818.
    1. Byhahn C, Wilke HJ, Halbig S, Lischke V, Westphal K. Percutaneous tracheostomy: ciaglia blue rhino versus the basic ciaglia technique of percutaneous dilational tracheostomy. Anesth Analg. 2000;91(4):882–886. doi: 10.1097/00000539-200010000-00021.
    1. Braune S, Kienast S, Hadem J, Wiesner O, Wichmann D, Nierhaus A, Simon M, Welte T, Kluge S. Safety of percutaneous dilatational tracheostomy in patients on extracorporeal lung support. Intensive Care Med. 2013;39(10):1792–1799. doi: 10.1007/s00134-013-3023-8.
    1. Cormack RS, Lehane J. Difficult tracheal intubation in obstetrics. Anaesthesia. 1984;39(11):1105–1111. doi: 10.1111/j.1365-2044.1984.tb08932.x.
    1. Grensemann J, Eichler L, Hopf S, Jarczak D, Simon M, Kluge S. Feasibility of an endotracheal tube-mounted camera for percutaneous dilatational tracheostomy. Acta Anaesthesiol Scand. 2017;61(6):660–667. doi: 10.1111/aas.12904.
    1. Grensemann J, Eichler L, Kahler S, Jarczak D, Simon M, Pinnschmidt HO, Kluge S. Bronchoscopy versus an endotracheal tube mounted camera for the peri-interventional visualization of percutaneous dilatational tracheostomy - a prospective, randomized trial (VivaPDT) Crit Care. 2017;21(1):330. doi: 10.1186/s13054-017-1901-0.
    1. Knaus WA, Draper EA, Wagner DP, Zimmerman JE. APACHE II: a severity of disease classification system. Crit Care Med. 1985;13(10):818–829. doi: 10.1097/00003246-198510000-00009.
    1. Vincent JL, Moreno R, Takala J, Willatts S, De Mendonca A, Bruining H, Reinhart CK, Suter PM, Thijs LG. The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine. Intensive Care Med. 1996;22(7):707–710. doi: 10.1007/BF01709751.
    1. Ferraro F, Capasso A, Troise E, Lanza S, Azan G, Rispoli F, Anello CB. Assessment of ventilation during the performance of elective endoscopic-guided percutaneous tracheostomy: clinical evaluation of a new method. Chest. 2004;126(1):159–164. doi: 10.1378/chest.126.1.159.
    1. Reilly PM, Sing RF, Giberson FA, Anderson HL, 3rd, Rotondo MF, Tinkoff GH, Schwab CW. Hypercarbia during tracheostomy: a comparison of percutaneous endoscopic, percutaneous Doppler, and standard surgical tracheostomy. Intensive Care Med. 1997;23(8):859–864. doi: 10.1007/s001340050422.
    1. Lawson RW, Peters JI, Shelledy DC. Effects of fiberoptic bronchoscopy during mechanical ventilation in a lung model. Chest. 2000;118(3):824–831. doi: 10.1378/chest.118.3.824.
    1. Grensemann J, Eichler L, Kähler S, Jarczak D, Simon M, Pinnschmidt HO, Kluge S. Comparing fiberoptic bronchoscopy and a tracheal tube-mounted camera-guided percutaneous dilatational tracheostomy: authors' reply. Crit Care. 2018;22(1):84. doi: 10.1186/s13054-018-2004-2.
    1. Chateauvieux C, Farah L, Guerot E, Wermert D, Pineau J, Prognon P, Borget I, Martelli N. Single-use flexible bronchoscopes compared with reusable bronchoscopes: Positive organizational impact but a costly solution. J Eval Clin Pract. 2018;24(3):528–535. doi: 10.1111/jep.12904.
    1. Sohrt A, Ehlers L, Udsen FW, Maerkedahl A, McGrath BA. Cost Comparison of Single-Use Versus Reusable Bronchoscopes Used for Percutaneous Dilatational Tracheostomy. Pharmacoecon Open. 2019;3(2):189–195. doi: 10.1007/s41669-018-0091-2.
    1. Mehta AC, Muscarella LF. Bronchoscope-Related "Superbug" Infections. Chest. 2020;157(2):454–469. doi: 10.1016/j.chest.2019.08.003.
    1. Ofstead CL, Quick MR, Wetzler HP, Eiland JE, Heymann OL, Sonetti DA, Ferguson JS. Effectiveness of Reprocessing for Flexible Bronchoscopes and Endobronchial Ultrasound Bronchoscopes. Chest. 2018;154(5):1024–1034. doi: 10.1016/j.chest.2018.04.045.
    1. Bundesgesundheitsblatt Hygiene Requirements for Reprocessing Flexible Endoscopes and Additional Endoscopic Instrumentation. - Gesundheitsforschung - Gesundheitsschutz. 2002;45(4):395–411. doi: 10.1007/s00103-002-0395-2.
    1. Papra K, Knappe T, Gutz S. Pneumologie. 2016;70(12):826–830.
    1. Vrijens F, Hulstaert F, Devriese S, Van De Sande S. Hospital-acquired infections in Belgian acute-care hospitals: an estimation of their global impact on mortality, length of stay and healthcare costs. Epidemiol Infect. 2012;140(1):126–136. doi: 10.1017/S0950268811000100.
    1. Trybou J, Spaepen E, Vermeulen B, Porrez L, Annemans L. Hospital-acquired infections in Belgian acute-care hospitals: financial burden of disease and potential cost savings. Acta Clin Belg. 2013;68(3):199–205. doi: 10.2143/ACB.3258.
    1. Reynolds S, Zurba J, Duggan L. A single-centre case series assessing the Ambu((R)) aScope 2 for percutaneous tracheostomies: A viable alternative to fibreoptic bronchoscopes. Can J Respir Ther. 2015;51(2):43–45.
    1. Percutaneous Dilatational Tracheostomy Consensus Statement. In.: Australian and New Zealand Intensive Care Society; 2014.
    1. Gobatto AL, Besen BA, Tierno PF, Mendes PV, Cadamuro F, Joelsons D, Melro L, Carmona MJ, Santori G, Pelosi P, et al. Ultrasound-guided percutaneous dilational tracheostomy versus bronchoscopy-guided percutaneous dilational tracheostomy in critically ill patients (TRACHUS): a randomized noninferiority controlled trial. Intensive Care Med. 2016;42(3):342–351. doi: 10.1007/s00134-016-4218-6.
    1. Baumann HJ, Kemei C, Kluge S. Die Tracheotomie auf der Intensivstation. Pneumologie. 2010;64(12):769–776. doi: 10.1055/s-0030-1255743.
    1. Jackson LS, Davis JW, Kaups KL, Sue LP, Wolfe MM, Bilello JF, Lemaster D. Percutaneous tracheostomy: to bronch or not to bronch–that is the question. J Trauma. 2011;71(6):1553–1556.

Source: PubMed

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