The study protocol for the Head Injury Retrieval Trial (HIRT): a single centre randomised controlled trial of physician prehospital management of severe blunt head injury compared with management by paramedics

Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine

Val Gebski¹  Michael Fearnside²  Alan A Garner³ 

[1] Biostatistics and Research Methodology, NHMRC Clinical Trials Centre, University of Sydney, Camperdown, NSW, Australia;Emeritus Consultant Neurosurgery, Westmead Hospital, Sydney, NSW, Australia;CareFlight Ltd, Westmead, NSW, Australia

关键词: Intubation;    Paramedic;    Physician;    Prehospital;    Brain injury;   

Others  :  810745
DOI  :  10.1186/1757-7241-21-69

 received in 2013-06-12, accepted in 2013-09-08,  发布年份 2013

【 摘 要 】

Background

The utility of advanced prehospital interventions for severe blunt traumatic brain injury (BTI) remains controversial. Of all trauma patient subgroups it has been anticipated that this patient group would most benefit from advanced prehospital interventions as hypoxia and hypotension have been demonstrated to be associated with poor outcomes and these factors may be amenable to prehospital intervention. Supporting evidence is largely lacking however. In particular the efficacy of early anaesthesia/muscle relaxant assisted intubation has proved difficult to substantiate.

Methods

This article describes the design and protocol of the Head Injury Retrieval Trial (HIRT) which is a randomised controlled single centre trial of physician prehospital care (delivering advanced interventions such as rapid sequence intubation and blood transfusion) in addition to paramedic care for severe blunt TBI compared with paramedic care alone.

Results

Primary endpoint is Glasgow Outcome Scale score at six months post injury. Issues with trial integrity resulting from drop ins from standard care to the treatment arm as the result of policy changes by the local ambulance system are discussed.

Conclusion

This randomised controlled trial will contribute to the evaluation of the efficacy of advance prehospital interventions in severe blunt TBI.

Trial Registration

ClinicalTrials.gov:NCT00112398

【 授权许可】

   
2013 Garner et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Bartolacci RA, Munford BJ, Lee A, McDougall PA: Air medical scene response to blunt trauma: effect on early survival. Med J Aust 1998, 169:610-615.
• [2]Garner A, Rashford S, Lee A, Bartolacci R: Addition of physicians to paramedic helicopter services decreases blunt trauma mortality. Aust N Z J Surg 1999, 69:697-701.
• [3]Garner A, Crooks J, Lee A, Bishop R: Efficacy of prehospital critical care teams for severe blunt head injury in the Australian setting. Injury 2001, 32(6):455-460.
• [4]Soon PSH, Caldwell E, Kolkman K, Sugrue M: Evaluation of the airway management of unconscious trauma patients. Aust N Z J Surg 1999, 69:A88. (suppl.) (abstract)
• [5]Singbartl G: Die Bedeutung der präklinischen notfallversorgung für die prognose von patienten mit schwerem schädel-hirn-trauma. Anästh Intesivther Notfallmed 1985, 20:251-260.
• [6]Dybkowska K, Pakulski C, Sumlinski W, Michalska-Krrzanowska G: Krytyczna ocena postępowania lekarskiego u chorych z obraźeniami czaszkowo – mózgowymi od momentu wypadku do zakończenia diagnostyke. Przegl Lek 1998, 55(12):650-653.
• [7]Baxt WG, Moody P: The impact of advanced prehospital emergency care on the mortality of severely brain-injured patients. J Trauma 1987, 27(4):365-369.
• [8]Celli P, Fruin A, Cervoni L: Severe head trauma; review of the factors influencing the prognosis. Minerva Chir 1997, 52:1467-1480.
• [9]Garner AA, Lee A, Weatherall A: Physician staffed helicopter emergency medical service dispatch via centralised control or directly by crew – case identification rates and effect on the Sydney paediatric trauma system. Scand J Trauma Resusc Emerg Med 2012, 20:82. BioMed Central Full Text
• [10]Oppe S, De Charro FT: The effect of medical care by a helicopter trauma team on the probability of survival and the quality of life of hospitalised victims. Accid Anal Prev 2001, 33:129-138.
• [11]Jennett B, Bond M: Assessment of outcome after severe brain damage: a practical scale. Lancet 1975, 305:480-484.
• [12]Wilson JTL, Pettigrew LEL, Teasdale GM: Structured interviews for the Glasgow outcome scale and the extended Glasgow outcome scale: guidelines for their Use. J Neurotrauma 1998, 15(8):573-585.
• [13]Marshall LF: Neurobehavioral outcome: The neurosurgeon’s perspective. In Neurobehavioral recovery from head injury. Edited by Levin HS, Grafman J, Eisenberg HM. Oxford: Oxford University Press; 1987:206-212.
• [14]Clifton GL, Hayes RL, Levin HS, Michel ME, Choi SC: Outcome measures for clinical trials involving traumatically brain-injured patients: report of a conference. Neurosurgery 1992, 31:975-978.
• [15]National Health and Medical Research Council, Australian Research Council & Australian Vice-Chancellors’ Committee: National Statement on Ethical Conduct in Human Research. 2007. [Australian Government] [http://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/e72_national_statement_130207.pdf webcite]
• [16]Baxt WG, Moody P: The impact of a physician as part of the aeromedical prehospital team in patients with blunt trauma. JAMA 1987, 257:3246.
• [17]Bernard SA, Nguyen V, Cameron P: Prehospital rapid sequence intubation improves functional outcome for patients with severe traumatic brain injury: a randomized controlled trial. Ann Surg 2010, 252:959-965.