Protocol for a multicentre retrospective observational cohort study in Denmark: association between the intraoperative peripheral perfusion index and postoperative morbidity and mortality in acute non-cardiac surgical patients

Marianne Agerskov, Anna Nicoline Wolfhagen Thusholdt, Jakob Højlund, Christian Sahlholdt Meyhoff, Henrik Sørensen, Sebastian Wiberg, Niels Henry Secher, Nicolai Bang Foss, Marianne Agerskov, Anna Nicoline Wolfhagen Thusholdt, Jakob Højlund, Christian Sahlholdt Meyhoff, Henrik Sørensen, Sebastian Wiberg, Niels Henry Secher, Nicolai Bang Foss

Abstract

Introduction: Perioperative haemodynamic instability is associated with postoperative morbidity and mortality. Macrocirculatory parameters, such as arterial blood pressure and cardiac output are associated with poor outcome but may be uncoupled from the microcirculation during sepsis and hypovolaemia and may not be optimal resuscitation parameters. The peripheral perfusion index (PPI) is derived from the pulse oximetry signal. Reduced peripheral perfusion is associated with morbidity in critically ill patients and in patients following acute surgery. We hypothesise that a low intraoperative PPI is independently associated with postoperative complications and mortality.

Methods and analysis: We plan to conduct a retrospective cohort study in approximately 2300 patients, who underwent acute non-cardiac surgery (1 November 2017 to 31 October 2018) at two Danish University Hospitals. Data will be collected from patient records including patient demographics, comorbidity and intraoperative haemodynamic values with PPI as the primary exposure variable, and postoperative complications and mortality within 30 and 90 days as outcome variables. We primarily assess association between PPI and outcome in multivariate regression models. Second, the predictive value of PPI for outcome, using area under the receiver operating characteristics curve is assessed.

Ethics and dissemination: Data will be reported according to the Strengthening the Reporting of Observational Studies in Epidemiology and results published in a peer-reviewed journal. The study is approved by the regional research ethics committee, storage and management of data has been approved by the Regional Data Protection Agency, and access to medical records is approved by the hospital board of directors (ClinicalTrials.gov registration no: NCT03757442).

Keywords: adult anaesthesia; haemodynamics; intensive and critical care; peripheral perfusion.

Conflict of interest statement

Competing interests: CSM: As head of research, the department receives direct and indirect research funding from Boehringer Ingelheim; Ferring Pharmaceuticals; and Merck, Sharp and Dohme, outside submitted work.

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

References

    1. Stoneham M, Murray D, Foss N. Emergency surgery: the big three--abdominal aortic aneurysm, laparotomy and hip fracture. Anaesthesia 2014;69 Suppl 1:70–80. 10.1111/anae.12492
    1. Pearse RM, Harrison DA, James P, et al. . Identification and characterisation of the high-risk surgical population in the United Kingdom. Crit Care 2006;10:R81 10.1186/cc4928
    1. Hashmi A, Ibrahim-Zada I, Rhee P, et al. . Predictors of mortality in geriatric trauma patients. J Trauma Acute Care Surg 2014;76:894–901. 10.1097/TA.0b013e3182ab0763
    1. McGwin G, MacLennan PA, Fife JB, et al. . Preexisting conditions and mortality in older trauma patients. J Trauma 2004;56:1291–6. 10.1097/01.TA.0000089354.02065.D0
    1. Parker M. Johansen A: hip fracture. BMJ 2006;333:27–30.
    1. Foss NB, Christensen DS, Krasheninnikoff M, et al. . Post-Operative rounds by anaesthesiologists after hip fracture surgery: a pilot study. Acta Anaesthesiol Scand 2006;50:437–42. 10.1111/j.1399-6576.2005.00944.x
    1. Kehlet H, Dahl JB. Anaesthesia, surgery, and challenges in postoperative recovery. The Lancet 2003;362:1921–8. 10.1016/S0140-6736(03)14966-5
    1. Tengberg LT, Foss NB, Lauritsen ML, et al. . The impact of acute high-risk abdominal surgery on quality of life in elderly patients. Dan Med J 2017;64.
    1. Ingraham AM, Cohen ME, Bilimoria KY, et al. . Comparison of 30-day outcomes after emergency general surgery procedures: potential for targeted improvement. Surgery 2010;148:217–38. 10.1016/j.surg.2010.05.009
    1. Sessler DI, Bloomstone JA, Aronson S, et al. . Perioperative quality initiative consensus statement on intraoperative blood pressure, risk and outcomes for elective surgery. Br J Anaesth 2019;122:563–74. 10.1016/j.bja.2019.01.013
    1. Pearse RM, Harrison DA, MacDonald N, et al. . Effect of a perioperative, cardiac output-guided hemodynamic therapy algorithm on outcomes following major gastrointestinal surgery: a randomized clinical trial and systematic review. JAMA 2014;311:2181–90. 10.1001/jama.2014.5305
    1. Edwards MR, Forbes G, MacDonald N, et al. . Optimisation of perioperative cardiovascular management to improve surgical outcome II (optimise II) trial: study protocol for a multicentre international trial of cardiac output-guided fluid therapy with low-dose inotrope infusion compared with usual care in patients undergoing major elective gastrointestinal surgery. BMJ Open 2019;9:e023455 10.1136/bmjopen-2018-023455
    1. FLOELA Fluid optimisation in emergency laparotomy trial. Available:
    1. van Genderen ME, Klijn E, Lima A, et al. . Microvascular perfusion as a target for fluid resuscitation in experimental circulatory shock. Crit Care Med 2014;42:e96–105. 10.1097/CCM.0b013e3182a63fbf
    1. Lima A, van Bommel J, Jansen TC, et al. . Low tissue oxygen saturation at the end of early goal-directed therapy is associated with worse outcome in critically ill patients. Crit Care 2009;13 10.1186/cc8011
    1. Sessler DI, Turan A, Stapelfeldt WH, et al. . Triple-low alerts do not reduce mortality: a real-time randomized trial. Anesthesiology 2019;130:72–82. 10.1097/ALN.0000000000002480
    1. Hernández G, Ospina-Tascón GA, Damiani LP, et al. . Effect of a resuscitation strategy targeting peripheral perfusion status vs serum lactate levels on 28-day mortality among patients with septic shock: the ANDROMEDA-SHOCK randomized clinical trial. JAMA 2019;321:654–64. 10.1001/jama.2019.0071
    1. Goldman JM, Petterson MT, Kopotic RJ, et al. . Masimo signal extraction pulse oximetry. J Clin Monit Comput 2000;16:475–83. 10.1023/A:1011493521730
    1. Lima AP, Beelen P, Bakker J. Use of a peripheral perfusion index derived from the pulse oximetry signal as a noninvasive indicator of perfusion. Crit Care Med 2002;30:1210–3. 10.1097/00003246-200206000-00006
    1. van Genderen ME, Bartels SA, Lima A, et al. . Peripheral perfusion index as an early predictor for central hypovolemia in awake healthy volunteers. Anesth Analg 2013;116:351–6. 10.1213/ANE.0b013e318274e151
    1. van Genderen ME, Paauwe J, de Jonge J, et al. . Clinical assessment of peripheral perfusion to predict postoperative complications after major abdominal surgery early: a prospective observational study in adults. Crit Care 2014;18:R114–13. 10.1186/cc13905
    1. Oskay A, Eray O, Dinç SE, et al. . Prognosis of critically ill patients in the ED and value of perfusion index measurement: a cross-sectional study. Am J Emerg Med 2015;33:1042–4. 10.1016/j.ajem.2015.04.033
    1. Leone M, Blidi S, Antonini F, et al. . Oxygen tissue saturation is lower in nonsurvivors than in survivors after early resuscitation of septic shock. Anesthesiology 2009;111:366–71. 10.1097/ALN.0b013e3181aae72d
    1. He H-wu, Liu D-wei, Long Y, et al. . The peripheral perfusion index and transcutaneous oxygen challenge test are predictive of mortality in septic patients after resuscitation. Crit Care 2013;17:R116 10.1186/cc12788
    1. Walsh M, Devereaux PJ, Garg AX, et al. . Relationship between intraoperative mean arterial pressure and clinical outcomes after noncardiac surgery: toward an empirical definition of hypotension. Anesthesiology 2013;119:507–15. 10.1097/ALN.0b013e3182a10e26
    1. Dindo D, Demartines N, Clavien P-A. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 2004;240:205–13. 10.1097/
    1. Sankar A, Johnson SR, Beattie WS, et al. . Reliability of the American Society of Anesthesiologists physical status scale in clinical practice. Br J Anaesth 2014;113:424–32. 10.1093/bja/aeu100
    1. Oken MM, Creech RH, Tormey DC, et al. . Toxicity and response criteria of the eastern cooperative Oncology Group. Am J Clin Oncol 1982;5:649–56. 10.1097/00000421-198212000-00014
    1. Charlson ME, Pompei P, Ales KL, et al. . A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis 1987;40:373–83. 10.1016/0021-9681(87)90171-8
    1. Quan H, Li B, Couris CM, et al. . Updating and validating the Charlson comorbidity index and score for risk adjustment in hospital discharge Abstracts using data from 6 countries. Am J Epidemiol 2011;173:676–82. 10.1093/aje/kwq433
    1. Foss NB, Kehlet H. Mortality analysis in hip fracture patients: implications for design of future outcome trials. Br J Anaesth 2005;94:24–9. 10.1093/bja/aei010
    1. Eschbach D-A, Oberkircher L, Bliemel C, et al. . Increased age is not associated with higher incidence of complications, longer stay in acute care hospital and in hospital mortality in geriatric hip fracture patients. Maturitas 2013;74:185–9. 10.1016/j.maturitas.2012.11.003
    1. Whittemore AS. Sample size for logistic regression with small response probability. J Am Stat Assoc 1981;76:27–32. 10.1080/01621459.1981.10477597
    1. Hosmer D, Lemeshow S. Applied logistic regression. 2nd edn Wiley, 2000.
    1. Staff J, Owners DJ, Freedom E, et al. . Registration KCT: recommendations for the conduct, reporting, editing, and publication of scholarly work in medical journals 2013:1–17.
    1. Bossuyt PM, Reitsma JB, Bruns DE, et al. . The STARD statement for reporting studies of diagnostic accuracy: explanation and elaboration. Ann Intern Med 2003;138:W1–12. 10.7326/0003-4819-138-1-200301070-00012-w1
    1. Myles PS, Boney O, Botti M, et al. . Systematic review and consensus definitions for the standardised endpoints in perioperative medicine (step) initiative: patient comfort. Br J Anaesth 2018;120:705–11. 10.1016/j.bja.2017.12.037

Source: PubMed

Sponsorit ja yhteistyökumppanit

Sairaudet

Huumeiden interventiot

3
Tilaa