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Awareness and Bispectral Index (BIS) Monitoring in Mechanically Ventilated Patients in the Emergency Department and Intensive Care Unit: a Systematic Review Protocol

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Awareness and Bispectral Index (BIS) Monitoring in Mechanically Ventilated Patients in the Emergency Department and Intensive Care Unit: a Systematic Review Protocol Open access Protocol BMJ Open: first published as 10.1136/bmjopen-2019-034673 on 4 March 2020. Downloaded from Awareness and bispectral index (BIS) monitoring in mechanically ventilated patients in the emergency department and intensive care unit: a systematic review protocol Ryan D Pappal,1 Brian W Roberts ,2 Winston Winkler,1 Lauren H Yaegar,3 Robert J Stephens ,4 Brian M Fuller 5 To cite: Pappal RD, Roberts BW, ABSTRACT Strengths and limitations of this study Winkler W, et al. Awareness Introduction Accidental awareness with recall is one of and bispectral index (BIS) the most feared complications for patients undergoing monitoring in mechanically ► This work will be the most comprehensive assess- general anaesthesia and can lead to post-trauma tic stress ventilated patients in the ment of awareness with paralysis in mechanically emergency department and disorder in up to 70% of patients experiencing it. To reduce ventilated, sedated, critically ill patients to date. the incidence of awareness with recall, the bispectral intensive care unit: a systematic ► The results are expected to shed light on the in- review protocol. BMJ Open index monitor is recommended for patients receiving cidence of a highly morbid complication, identify 2020;10:e034673. doi:10.1136/ total intravenous anaesthetics, especially those receiving scientific gaps in the literature and identify future bmjopen-2019-034673 neuromuscular blockers. While extensive investigation into research targets to improve postintubation care. ► Prepublication history and awareness and bispectral index monitoring has occurred ► Relevant studies are unlikely to be missed, given the additional material for this for operating room patients, this has not extended to other methodological rigour of the systematic review. paper are available online. To clinical arenas where sedated and mechanically ventilated ► Meaningful results could be limited if there is a pau- view these files, please visit patients are cared for, namely the intensive care unit and city of literature regarding awareness with paralysis the journal online (http:// dx. doi. emergency department. The purpose of this systematic in patients in the emergency department and inten- org/ 10. 1136/ bmjopen- 2019- review is to assess the world’s literature to determine the sive care unit. 034673). incidence of awareness with paralysis in mechanically http://bmjopen.bmj.com/ Received 02 October 2019 ventilated patients and the impact of bispectral index Revised 11 February 2020 monitoring for reducing this complication. INTRODUCTION Accepted 12 February 2020 Methods and analysis Randomised trials and non- Accidental awareness with recall (AWR) is one randomised studies are eligible for inclusion. With aid of the most feared complications for patients from a medical librarian, an electronic search will include undergoing general anaesthesia in the Ovid Medline, Embase. com, Scopus, Cochrane Database operating room (OR). An incidence of 1–2 of Systematic Reviews and Cochrane Central Register of Controlled Trials. To find data published in abstract cases/1000 is supported by data from single- centre and multicentre cohort studies, as on October 2, 2021 by guest. Protected copyright. form, literature from professional society conferences 1–3 (2010–2019) will be manually searched. Two authors well as a randomised controlled trial. This will independently review search results and consensus topic is germane in the care of OR patients, will be reached with assistance from a third author, as multiple studies have shown an associa- as needed. Heterogeneity and publication bias will be tion between accidental awareness and post- assessed and reported. If possible and appropriate, traumatic stress disorder (PTSD), which can a meta-analysis of the data will be conducted for be crippling and refractory to treatment.4–8 quantitative data analysis. Risk factors for AWR include: (1) under- © Author(s) (or their Ethics and dissemination The proposed systematic dosing of anaesthesia; (2) lack of protocolled employer(s)) 2020. Re- use review does not require ethical approval, as it is conducted monitoring of sedation depth; (3) the use permitted under CC BY-NC. No at the study level and does not involve individual patient- commercial re- use. See rights of neuromuscular blocking drugs (ie, para- and permissions. Published by level data. Results will be disseminated by data sharing lytics) and (4) a total intravenous anaesthetic BMJ. via academically established means, presentation at local approach (vs inhaled anaesthetics). For numbered affiliations see and national scientific meetings and publication as a peer- The bispectral index monitor (BIS) is a reviewed manuscript. end of article. processed electroencephalogram (EEG) PROSPERO registration number The protocol has device applied non- invasively to the forehead Correspondence to been submitted to International Prospective Register of Dr Brian M Fuller; Systematic Reviews and is awaiting registration. via an adhesive electrode sensor strip. The fullerb@ wusm. wustl. edu BIS index provided as the output from the Pappal RD, et al. BMJ Open 2020;10:e034673. doi:10.1136/bmjopen-2019-034673 1 Open access BMJ Open: first published as 10.1136/bmjopen-2019-034673 on 4 March 2020. Downloaded from device is a dimensionless number ranging from 0, indi- ICU; (2) quantify the incidence of awareness with paral- cating suppression of detectable brain activity, to 100, ysis in this cohort of critically ill patients and (3) assess the indicating the awake state. A BIS of <60 has a high sensi- impact of BIS monitoring in reducing awareness events. tivity for identifying drug-induced unconsciousness, and We hypothesise that: (1) the literature will be limited in maintaining BIS values between 40 and 60 has been the terms of methodological rigour and quantity; (2) the inci- clinical strategy investigated for reducing the incidence dence of awareness with paralysis will be higher than that of AWR in the OR population.1 9–11 Extensive investiga- reported in the OR and (3) BIS monitoring will be asso- tion into the role of BIS monitoring for decreasing the ciated with a reduction in awareness events. By rigorously chance of AWR has been conducted in the OR. While examining awareness and BIS monitoring in critically not superior to a protocolled monitoring strategy based ill patients in ED and ICU, this systematic review will be on alarms which monitor end-tidal anaesthetic concen- an important contribution in the effort to provide goal- tration, BIS is superior to clinical signs alone, routine oriented sedation in the postintubation period. clinical care (ie, non-protocol driven monitoring) and for patients receiving total intravenous anaesthesia.1 9–13 Therefore, evidence- based recommendations regarding METHODS AND ANALYSIS mechanically ventilated patients in the OR endorse objec- Protocol and registration tive brain monitoring using BIS as a means to reduce the The Preferred Reporting Items for Systematic Reviews incidence of AWR in patients receiving total intravenous and Meta- Analysis Protocols (PRISMA- P) statement anaesthetics, especially in those receiving neuromuscular (see online supplementary material 1) has been used 12 14 blockers. to prepare this systematic review protocol. The PRISMA This focus on awareness and BIS monitoring has yet statement and the Meta- analysis of Observational Studies to extend to other clinical arenas where sedated and in Epidemiology guidelines will be used to report the final mechanically ventilated patients are cared for, namely results. If there is deviation from the protocol during the the intensive care unit (ICU) and emergency department conduct of this systematic review, it will be reported with (ED), where hundreds of thousands of patients require the final results, as well as the rationale for protocol devi- 15 16 mechanical ventilation annually. There is rationale ation. The electronic search for the systematic review was to believe that the incidence of awareness with paralysis conducted in June 2019; the intended completion date could be higher in these areas when compared with the for the entire work is estimated to be in December 2019. OR, given the vastly different practice and staffing models This systematic review has been submitted to the Interna- that exist (ie, nursing/clinician staffing ratios, more hectic tional Prospective Register of Systematic Reviews and is environment, less monitoring). Case reports and small awaiting registration. cohort studies have documented an incidence of aware- 17 18 ness with paralysis in patients in ICU as high as 35%. Search for and identification of studies http://bmjopen.bmj.com/ With respect to BIS monitoring, most ICU studies have An electronic search was designed in collaboration assessed the correlation between clinical sedation scales with a medical librarian experienced in the conduct of and BIS index values.19 The data regarding awareness comprehensive systematic reviews, and she performed with paralysis are quite limited, though one study did the electronic search. This search was designed to include show a reduction in awareness with paralysis from 18% to the following databases: Ovid Medline, Embase. com, 4% with the use of a BIS monitor to guide sedation titra- Scopus, Cochrane Database of Systematic Reviews and tion.17 Data from the ED domain are even more limited. the Cochrane Central Register of Controlled Trials. The Four small studies (n=123 patients total) showed an inci- search terms
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