CC BY-NC-ND 4.0 · Indian Journal of Neurotrauma 2020; 17(01): 17-23
DOI: 10.1055/s-0040-1713462
Original Article

Impact of Mild Hypothermia on Final Outcome of Patients with Acute Stroke: A Randomized Clinical Trial

Abbas Rouzbahani
1   Nursing and Midwifery School, Islamic Azad University, Urmia, Iran
,
Esmail Khodadadi
2   Iranian Social Security Organization, Urmia, Iran
,
Marjaneh Fooladi
3   World Wide Nursing Service Network, PLLC, El Paso, Texas, United States
› Author Affiliations
Sources of Funding The study was supported by Islamic Azad University, Urmia.

Abstract

Background and Aim Stroke is a sudden neurological disorder caused by disturbances in the brain blood flow and loss of normal brain function. Stroke is also the second leading cause of death worldwide. In the last two decades, among the various treatment options for stroke, hypothermia has shown the promise of improving the final outcome. This study aimed to investigate the effect of noninvasive hypothermia on the final outcome of patients with an acute stroke in Iran.

Methods In a randomized clinical trial, 60 Iranian patients diagnosed with acute stroke were enrolled in 2018. Patients were selected by convenience sampling method and then randomized in two groups as experimental (n = 30) and control (n = 30). Mild hypothermia was applied using a cooling device for 72 hours on the patients’ heads and intervention results were compared with the control group. Data were collected by using Acute Physiology and Chronic Health Evaluation III (APACHE III), Full Outline of Un-Responsiveness (FOUR), and National Institutes of Health Stroke Scale (NIHSS), and later analyzed by Statistical Package for the Social Sciences (SPSS) software version 22.

Results No significant difference was found in the mean scores of all three scales before and after the intervention in control group (p > 0.05) but statistically significant difference was found in the mean scores of all three scales for the intervention group (p < 0.05). The intervention group had an increased mean score in FOUR, while APACHE and NIHSS values dropped. Researchers found statistically significant difference between the mean scores after the intervention in the experimental group compared with the control group in all three scales (p < 0.05).

Conclusion The findings of this study indicate that hypothermia has a significant statistical and clinical effect on the acute stroke outcome and it can be argued that hypothermia therapy can increase the level of consciousness and reduce the risk of death in stroke patients.

Appendix



Publication History

Article published online:
11 August 2020

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  • References

  • 1 Goetz CG. ed. Textbook of Clinical Neurology. Philadelphia, PA: Elsevier Health Sciences; 2007
  • 2 Bradley WG. ed. Neurology in Clinical Practice: Principles of Diagnosis and Management. Abingdon: Taylor & Francis; 2004
  • 3 Malani PN. Harrison’s principles of internal medicine. JAMA 2012; 308: 1813-1814
  • 4 Daneshfard B, Izadi S, Shariat A, Toudaji MA, Beyzavi Z, Niknam L. Epidemiology of stroke in Shiraz, Iran. Iran J Neurol 2015; 14 (03) 158-163
  • 5 Tran J, Mirzaei M, Anderson L, Leeder SR. The epidemiology of stroke in the Middle East and North Africa. J Neurol Sci 2010; 295 (1-2) 38-40
  • 6 Kim JS. Stroke in Asia: a global disaster. Int J Stroke 2014; 9 (07) 856-857
  • 7 Mehndiratta MM, Khan M, Mehndiratta P, Wasay M. Stroke in Asia: geographical variations and temporal trends. J Neurol Neurosurg Psychiatry 2014; 85 (12) 1308-1312
  • 8 Ghandehari K. Epidemiology of stroke in Iran. GMJ 2016; 5: 3-9
  • 9 Caplan LR. ed. Caplan's stroke. New York: Cambridge University Press; 2016
  • 10 Oliveira V, Kumutha JR, Narayanan E. et al. Hypothermia for encephalopathy in low-income and middle-income countries: feasibility of whole-body cooling using a low-cost servo-controlled device. BMJ Paediatr Open 2018; 2 (01) e000245
  • 11 Bergan HA, Halvorsen PS, Skulstad H, Fosse E, Bugge JF. Does therapeutic hypothermia during extracorporeal cardiopulmonary resuscitation preserve cardiac function?. J Transl Med 2016; 14 (01) 345
  • 12 Krawczyk P, Kołodziej G, Szpyra B, Andres J. Implementation of therapeutic hypothermia after cardiac arrest in intensive care units in Poland. Kardiol Pol 2013; 71 (03) 270-274 (Polish Heart Journal)
  • 13 Takeda Y, Kawashima T, Kiyota K. et al. Feasibility study of immediate pharyngeal cooling initiation in cardiac arrest patients after arrival at the emergency room. Resuscitation 2014; 85 (12) 1647-1653
  • 14 Ahmed AI, Bullock MR, Dietrich WD. Hypothermia in traumatic brain injury. Neurosurg Clin N Am 2016; 27 (04) 489-497
  • 15 Crompton EM, Lubomirova I, Cotlarciuc I, Han TS, Sharma SD, Sharma P. Meta-analysis of therapeutic hypothermia for traumatic brain injury in adult and pediatric patients. Crit Care Med 2017; 45 (04) 575-583
  • 16 Chandrasekaran PN, Dezfulian C, Polderman KH. What is the right temperature to cool post-cardiac arrest patients?. Crit Care 2015; 19: 406
  • 17 Kan P, Duckworth E, Germanwala AV. et al. Neurosurgery concepts: key perspectives on embolectomy for stroke with emergent large vessel occlusion (MR CLEAN), endonasal endoscopic craniopharyngioma resection, gamma knife radiosurgery for meningiomas, therapeutic hypothermia for severe traumatic brain injury. Surg Neurol Int 2015; 6: 165
  • 18 Kurisu K, Yenari MA. Therapeutic hypothermia for ischemic stroke; pathophysiology and future promise. Neuropharmacology 2018; 134 (Pt B) 302-309
  • 19 Andresen M, Gazmuri JT, Marín A, Regueira T, Rovegno M. Therapeutic hypothermia for acute brain injuries. Scand J Trauma Resusc Emerg Med 2015; 23: 42
  • 20 Han Z, Liu X, Luo Y, Ji X. Therapeutic hypothermia for stroke: where to go?. Exp Neurol 2015; 272: 67-77
  • 21 Szczygielski J, Müller A, Mautes AE. et al. Selective brain hypothermia mitigates brain damage and improves neurological outcome after post-traumatic decompressive craniectomy in mice. J Neurotrauma 2017; 34 (08) 1623-1635
  • 22 Basiri B, Eghbalian F, Vakili Garmroodi K. Evolution of the therapeutic effects of induced local hypothermia in neonates with hypoxic-ischemic encephalopathy. Avicenna J Clin Med 2011; 18: 5-9
  • 23 Ehsani V, Allahtavakoli M, Dashti M. et al. Effect of general hypothermia on the embolic model of stroke in the male rat. J Shaheed Sdoughi Univ Med Sci Yazd 2014; 21: 776-783
  • 24 Allahtavakoli M, Kahnouei MH, Rezazadeh H. et al. Delayed combination therapy of local brain hypothermia and decompressive craniectomy on acute stroke outcome in rat. Iran J Basic Med Sci 2014; 17 (07) 476-482
  • 25 Hoseeini Kahnouei MA, Rezazadeh H, Mahmoudi MH, Purrashidy Basharabadi A, Alahtavakoli M. Protective effect of combination therapy of local brain hypothermia and decompressive craniectomy on stroke model in rat. J Mazandaran Univ Med Sci 2014; 24: 81-90
  • 26 Knaus WA, Wagner DP, Draper EA. et al. The APACHE III prognostic system. Risk prediction of hospital mortality for critically ill hospitalized adults. Chest 1991; 100 (06) 1619-1636
  • 27 Soleimani M, Masoudi R, Bahrami N, Qorbani M, Sadeghi T. Predicting mortality rate of patients in critical care unit using APACHE-II index. Majallah-i Danishgah-i Ulum-i Pizishki-i Gurgan 2010; 11: 64-69
  • 28 Motamed Al-shariati S, Rezaei E, BeiraghiToosi A. Comparison between acute physiology and chronic health evaluation system and abbreviated burn severity index (ABSI) in prediction of burn patient’s mortality. Med Uni Zahedan J 2011; 9: 33-38
  • 29 Wijdicks EF, Bamlet WR, Maramattom BV, Manno EM, McClelland RL. Validation of a new coma scale: the FOUR score. Ann Neurol 2005; 58 (04) 585-593
  • 30 Wolf CA, Wijdicks EF, Bamlet WR, McClelland RL. Further validation of the FOUR score coma scale by intensive care nurses. Mayo Clin Proc 2007; 82 (04) 435-438
  • 31 Iyer VN, Mandrekar JN, Danielson RD, Zubkov AY, Elmer JL, Wijdicks EF. Validity of the FOUR score coma scale in the medical intensive care unit. Mayo Clin Proc 2009; 84 (08) 694-701
  • 32 Cohen J. Interrater reliability and predictive validity of the FOUR score coma scale in a pediatric population. J Neurosci Nurs 2009; 41 (05) 261-267, quiz 268–269
  • 33 Tadrisi SD, Bahari N, Ebadi A, Madani SJ. Validity and reliability of coma scale (Four Score) in adult patient hospitalized in critical care units. Crit Care Nurse 2012; 5: 95-102
  • 34 Kasner SE, Chalela JA, Luciano JM. et al. Reliability and validity of estimating the NIH stroke scale score from medical records. Stroke 1999; 30 (08) 1534-1537
  • 35 Hinkle JL. Reliability and validity of the National Institutes of Health Stroke Scale for neuroscience nurses. Stroke 2014; 45 (03) e32-e34
  • 36 Kazemnejad LE, Rezaei S, Hosseini-Nejad M, Bakhshayesh EB, Saberi A, Keshavarz P. The applicability, concurrent validity and internal consistency reliability of the Persian version of the National Institutes of Health Stroke Scale (NIHSS): evidences for gender differences. Caspian J Neurol Sci 2016; 2: 18-28
  • 37 Hutchison JS, Ward RE, Lacroix J. et al. Hypothermia Pediatric Head Injury Trial Investigators and the Canadian Critical Care Trials Group. Hypothermia therapy after traumatic brain injury in children. N Engl J Med 2008; 358 (23) 2447-2456
  • 38 Bayegan K, Janata A, Frossard M. et al. Rapid non-invasive external cooling to induce mild therapeutic hypothermia in adult human-sized swine. Resuscitation 2008; 76 (02) 291-298
  • 39 Jeong H-Y, Chang J-Y, Yum KS. et al. Extended use of hypothermia in elderly patients with malignant cerebral edema as an alternative to hemicraniectomy. J Stroke 2016; 18 (03) 337-343
  • 40 Krieger DW, Yenari MA. Therapeutic hypothermia for acute ischemic stroke: what do laboratory studies teach us. ? Stroke 2004; 35 (06) 1482-1489
  • 41 Schultheiss M, Schnichels S, Hermann T. et al. Hypothermia protects and prolongs the tolerance time of retinal ganglion cells against ischemia. PLoS One 2016; 11 (02) e0148616
  • 42 Bi Y, Huan Y, Cai W. et al. Mild hypothermia in combination with minimally invasive evacuation of hematoma reduces inflammatory damage in patients via the nuclear factor-κB pathway. Exp Ther Med 2014; 8 (06) 1717-1722
  • 43 Alzaga AG, Cerdan M, Varon J. Therapeutic hypothermia. Resuscitation 2006; 70 (03) 369-380
  • 44 Nogueira AB, Nogueira AB, Esteves Veiga JC, Teixeira MJ. Multimodality monitoring, inflammation, and neuroregeneration in subarachnoid hemorrhage. Neurosurgery 2014; 75 (06) 678-689
  • 45 Dénes A, Ferenczi S, Kovács KJ. Systemic inflammatory challenges compromise survival after experimental stroke via augmenting brain inflammation, blood-brain barrier damage and brain oedema independently of infarct size. J Neuroinflammation 2011; 8: 164
  • 46 Macleod MR, Petersson J, Norrving B. et al. European Hypothermia Stroke Research Workshop. Hypothermia for stroke: call to action 2010. Int J Stroke 2010; 5 (06) 489-492
  • 47 Lyden PD, Allgren RL, Ng K. et al. Intravascular Cooling in the Treatment of Stroke (ICTuS): early clinical experience. J Stroke Cerebrovasc Dis 2005; 14 (03) 107-114
  • 48 Poli S, Purrucker J, Priglinger M. et al. Rapid Induction of COOLing in Stroke Patients (iCOOL1): a randomised pilot study comparing cold infusions with nasopharyngeal cooling. Crit Care 2014; 18 (05) 582
  • 49 Tahir RA, Pabaney AH. Therapeutic hypothermia and ischemic stroke: a literature review. Surg Neurol Int 2016; 7 (Suppl. 14) S381-S386