Archives of Academic Emergency Medicine. 2019; 7 (1): e35 OR I G I N A L RE S E A RC H Early Intubation vs. Supportive Care Outcomes in Patients with Severe Chest Trauma; a randomized trial study Mohammad Nasr-Esfahani1, Amir Bahador Boroumand2∗, Mohsen Kolahdouzan3 1. Department of Emergency Medicine, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran. 2. Department of Emergency Medicine, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran. 3. Department of surgery, Faculty of medicine, Isfahan university of medical sciences, Isfahan, Iran. Received: March 2019; Accepted: May 2019; Published online: 9 July 2019 Abstract: Introduction: Early intubation is one of the critical issues in patients with chest trauma. This study aimed to examine the effect of early intubation on outcomes of patients with severe blunt chest trauma. Methods: This clinical trial was performed on patients with blunt chest trauma referring to emergency department. Patients were randomly divided to intervention (early intubation) and control (supportive care) groups and the dura- tion of hospitalization, complete recovery rate, laboratory changes, and in hospital mortality were compared between the two groups. Results: 64 cases were divided into two equal groups of early intubation and control. There were no significant differences between two groups regarding age (p=0.36), sex (p=0.26), type of trauma (p>0.05), and comorbid diseases (p>0.05). The duration of hospitalization in the early intubation group was sig- nificantly lower than that of the control group (p = 0.01). 90.6% of those in early intubation group and 68.8% of those in the control group showed complete recovery (p = 0.03). There was no case of mortality in either group. There was a significant difference in venous blood pH between the groups at 6, 12, 18 and 24 hours after intu- bation (p < 0.05). Also, there was a significant difference in the HCO3 level at 6 and 12 hours after intubation (p <0.05). Conclusion: Early intubation is better than supportive treatment in patients with severe chest trauma because of a better complete recovery rate, lower duration of hospitalization, and better acid/base situation. Keywords: Intubation; wounds and injuries; thorax; hospitalization; multiple trauma Cite this article as: Nasr-Esfahani M, Boroumand A B, Kolahdouzan M. Early Intubation vs. Supportive Care Outcomes in Patients with Severe Chest Trauma; a randomized trial study. Arch Acad Emerg Med. 2019; 7(1): e35. 1. Introduction Severe blunt chest trauma may causes rupture of the lung tis- sue, pulmonary contusion, intra-parenchymal hemorrhage, and alveolar collapse (1). Examination of chest injuries at the capillary level has shown that pulmonary contusion can lead to lung edema, alveolar edema, and even severe perivascu- lar edema, resulting in the activation of inflammatory me- diators, each of which causes lung tissue edema and inap- propriate function of vascular permeability and changes in surfactant, even in areas that have not been traumatized (1- 3). Airway management is one of the first and most im- portant principles of saving the lives of traumatic individu- als, which should be done properly in people who are ex- ∗Corresponding Author: Amir Bahador Boroumand, School of Medicine, Isfa- han University of Medical Sciences, Isfahan, Iran; Email: Abbg68@yahoo.com; Tel:+989359847673 pected to have a respiratory problem (4). Failure to pro- tect the airway is the most important cause of preventable mortality after a traumatic event (5). The most important ways of protecting the respiratory tract are laryngoscopy and endotracheal intubation, which are the most reliable, safe and most commonly used methods for facilitating ventila- tion (6). Depending on the severity of chest trauma, 50-70% of people develop respiratory failure (7), and they need to be intubated. Given the importance of intubation in trauma patients, in 2002 the Eastern Association for the Surgery of Trauma (EAST) has defined indications for immediate intu- bation in traumatic individuals. These indications include: airway obstruction, reduced respiratory rate, severe hypox- emia, decreased consciousness and severe brain injury (Glas- gow Coma Scale (GCS) ≤ 8), cardiac arrest, and severe hem- orrhagic shock (8, 9). Such indications are known as early and late indications of intubation. But, some of the intuba- tions that can be performed shortly after the trauma based on the decision of the physician, or for other reasons indica- This open-access article distributed under the terms of the Creative Commons Attribution NonCommercial 3.0 License (CC BY-NC 3.0). Downloaded from: http://journals.sbmu.ac.ir/aaem M. Nasr-Esfahani et al. 2 tive of the patient’s need for intubation. Such indications, usually include damage to the face, changes in the level of consciousness, difficulty breathing, respiratory distress, in- toxication, and preoperative control (8). A study by Trupka et al. showed that early intubation of trauma patients within 2 hours after injury is a useful and safe method that is capable of reducing post-traumatic organ failure and improving outcome (10). But, Sise et al. found no significant difference between the patients who underwent early intubation and the control group regarding the rate of hypotension, bradycardia, and aspiration (8). Considering the contradictory results presented in the studies and the im- portance of preserving airways in patients with chest trauma and pulmonary damage, this study aimed to compare the outcomes of early intubation versus supportive care in man- agement of patients with severe blunt chest trauma. 2. Methods 2.1. Study design and setting This randomized clinical trial was performed on patients with multiple traumatic injuries referring to emergency de- partment (Level I) of Al-Zahra and Kashani Hospitals, Isfa- han. Iran, from Jan 2016 to Dec 2018. The methodology of this research was approved by Ethics committee of Isfahan University of Medical Sciences (code=IR.MUI.REC.1397.074). This study is registered in Iranian registry of clinical trials database with IRCT20130311012782N31 code. 2.2. Participants All adult (age > 18 years) multiple trauma patients with a trauma severity score of ≥ 5 based on Thoracic Trauma Sever- ity (TTS) scoring system, with informed consent and agree- ment for participating were included. Patients who needed rapid-sequence intubation (less than 6 minutes after enter- ing the emergency room), including severe head trauma pa- tients with GCS ≤8, patients with respiratory distress with respiratory rate less than 9 and/or more than 30, airway ob- struction, severe hypoxemia, cardiac arrhythmias, and severe hemorrhagic shock, as well as burns of more than 40%, se- vere burns of the face, oropharynx and trachea, and airway obstruction were not enrolled in the study. 2.3. Intervention After the initial evaluation, clinical examination, and crit- ical consideration by an emergency phycision, eligible pa- tients undewent portable chest radiology, and the patients’ trauma severity scores were calculated using TTS system (11). Then patients were randomly divided into two par- allel groups of early intubation (intervention) or supportive care (control) using random allocation software (block ran- domization method). After full respiratory and cardiac mon- Figure 1: Flow diagram of patients enrollment. itoring, early intubation cases underwent endotracheal intu- bation using rapid sequence intubation method. All inter- vention subjects were ventilated using synchronized inter- mittent mechanical ventilation (SIMV ) mode, 8cc per kilo- gram tidal volume, 100% Fio2, and 12 times respiration per minute. Patients were extubated after one day (24 hours) of intubation, if they did not have the necessary contraindica- tions. Control group underwent routine supportive care such as, oxygen therapy with oxygen mask (100% oxygen with 8 to 10 liters per minute flow), head and neck positioning, pulse oximetry, and full respiratory and cardiac monitoring. Both groups received midazolam and fentanyl for relaxation and pain relief. All patients were managed by a senior emergency medicine resident under direct supervision of an emergency medicine specialist. 2.4. Data gathering Demographic data, type of trauma, need for blood transfu- sion, and trauma severity based on TTS were recorded for all patients. Venous blood gas analysis (pH, Hco3, Pco2, PaO2), vital signs (systolic blood pressure, diastolic blood pressure, pulse rate, temperature), hemoglobin (Hb), and blood sugar (BS) were measured and recorded every three hours until six hours after entering the emergency room and then every 6 hours (for 24 hours in total) for both group. 2.5. Outcomes The duration of hospitalization (from admission to discharge from surgery department), complete recovery rate, labora- tory and hemodynamic changes, and in hospital mortality were considered as measured outcomes. This open-access article distributed under the terms of the Creative Commons Attribution NonCommercial 3.0 License (CC BY-NC 3.0). Downloaded from: http://journals.sbmu.ac.ir/aaem 3 Archives of Academic Emergency Medicine. 2019; 7 (1): e35 Table 1: Baseline characteristics of patients in early intubation and supportive care groups Variable Early intubation Control P Age Mean ± SD 42.03±16.76 45.28±19.36 0.36 Sex Male 21 (65.6) 25 (78.1) 0.26 Female 11 (34.4) 7 (21.9) Comorbid disease Diabetes 7 (21.9) 6 (18.8) 0.75 Hypertension 12 (37.5) 7 (21.9) 0.17 Type of trauma Bone fracture 25 (75.1) 22 (68.8) 0.57 Pneumothorax 23 (74.2) 21 (65.6) 0.45 Hemothorax 14 (43.8) 12 (37.5) 0.61 Free intra-abdominal fluid 5 (15.6) 4 (12.5) 0.71 Trauma severity TTS score 7.53±1.66 7.18±1.53 0.56 Data are presented as mean ± standard deviation (SD) or frequency (%). TTS: Thoracic Trauma Severity. Table 2: Outcomes of patients in early intubation and supportive care groups Outcome Early intubation Control P Duration of hospitalization 5.18±1.33 9.43±2.25 0.01 Complete recovery 29 (90.6) 22 (68.8) 0.03 Recovery with complications 3 (9.4) 10 (31.3) 0.01 Data are presented as frequency (%). 2.6. Statistical analysis Considering 80% power and 95% confidence interval (CI), and the precision of estimation of 7% for standard devia- tion, minimum sample size was calculated to be 32 cases per group. Data were analyzed using SPSS version 20 software. Quantitative data were presented as mean and standard de- viation, and qualitative data were indicated as percentage and frequency. Chi-square test was used to compare quanti- tative data between the groups. Independent t-test was used to compare the qualitative data between the groups. Also, re- peated measures ANOVA was used to compare the changes in quantitative data at different times. A p-value less than 0.05 was considered as significant. 3. Results 3.1. Baseline characteristics of studied patients 64 cases were divided into two equal groups of early intuba- tion and control (figure 1). Table 1 compares the baseline characteristics of the studied patients. There were no sig- nificant differences between the two groups regarding age (p=0.36), sex (p=0.26), type of trauma (p>0.05), and comor- bid diseases (p>0.05). 3.2. Outcomes Tables 2 and 3 compare the studied outcomes between groups. The duration of hospitalization in the early intuba- tion group was significantly lower than that of the control group (p = 0.01). 90.6% of those in the early intubation group and 68.8% of those in control group showed complete recov- ery (p = 0.03). There was no case of mortality in either group. There was a significant difference in venous blood pH be- tween the groups at 6, 12, 18 and 24 hours after intubation. Also, there was a significant difference in the HCO3 level at 6 and 12 hours after intubation (p <0.05). 4. Discussion Based on the findings of this study, use of early intubation for patients with severe blunt trauma results in lower dura- tion of hospitalization and better acid/base balances without any hemodynamic and laboratory impairment. Recent stud- ies have focused more on protecting the patient and using less risky methods in patients who do not have a clear indi- cation for early intubation, while few studies have been done to discuss early intubation. A study done by Sise and colleagues examined the indica- tions for early intubation to evaluate the incidence and out- comes in 1,000 consecutive patients. They indicated that early intubation indications might change depending on the This open-access article distributed under the terms of the Creative Commons Attribution NonCommercial 3.0 License (CC BY-NC 3.0). Downloaded from: http://journals.sbmu.ac.ir/aaem M. Nasr-Esfahani et al. 4 Table 3: Venous blood gas analysis, vital signs, glucose and hemoglobin changes among patients in early intubation and supportive care groups Variable Early intubation Control P pH On arrival 7.30±0.09 7.18±0.13 0.21 3h 7.25±0.06 7.17±0.10 0.05 6h 7.38±0.09 7.23±0.17 0.006 12h 7.39±0.10 7.29±0.16 0.05 18h 7.40±0.07 7.36±0.15 0.009 24h 7.38±0.06 7.34±0.18 >0.001 HCO3 On arrival 23.63±5.54 18.42±8.86 0.18 3 22.41±7.53 18.23±7.03 0.68 6h 23.80±3.46 21.34±7.91 >0.001 12h 24.76±3.18 26.21±8.19 >0.001 18h 25.32±5.76 26.89±7.51 0.17 24h 24.70±6.18 26.02±7.27 0.34 PCO2 On arrival 50.05±16.73 47.41±19.17 0.76 3h 51.16±20.02 49.21±19.87 0.95 6h 49.18±13.52 40.49±9.14 0.02 12h 52.60v13.10 42.04±12.71 0.46 18h 45.90±9.78 42.69±10.25 0.57 24h 44.34±8.87 41.01±11.59 0.27 Systolic blood pressure (mmHg) On arrival 131.51±24.94 115.25±31.56 0.16 6h 120.96±18.89 116.25±24.66 0.58 12h 123.84±18.98 117.35±18.37 0.62 24h 130.43±18.36 122.01±21.84 0.62 Diastolic blood pressure (mmHg) On arrival 79.16±15.61 68.18±20.15 0.14 6h 77.40±13.53 70.21±14.08 0.84 12h 77.56±11.80 71.48±15.28 0.32 24h 81.20±11.24 75.76±14.32 0.35 Pulse rate (/minutes) On arrival 89.22Âś19.58 95.78±18.60 0.79 6h 88.06±15.16 93.37±22.03 0.14 12h 92.75±15.71 93.03±22.14 0.09 24h 89.06±13.79 91.61±19.02 0.10 Temperature (c) On arrival 37.12±0.48 37.09±0.57 0.74 6h 37.27±0.50 37.05±0.33 0.18 12h 37.32±0.47 37.20±0.47 0.42 24h 37.21±0.34 37.27±0.53 0.25 Blood sugar (mg/dl) On arrival 147.32±77.98 159.43±61.49 0.71 24h 163.38±112.76 167.31±115.29 0.70 Hemoglobin (mg/dl) On arrival 12.87±2.24 15.70±7.31 0.30 24h 14.20±5.81 13.59±2.18 0.28 surgeon’s view, and also no significant difference was found between the patients who underwent intubation and the control group for hypotension, bradycardia, trauma during intubation, and aspiration (8). The results of this study, which had a large sample size, are similar to our study as they considered early intubation to be practical and useful. Another study by Trupka et al showed that early intubation of injured patients within 2 h after trauma is a useful and safe method that is capable of reducing post-traumatic organ fail- ure and improving outcome (10). As indicated by studies, one of the indications that affect early intubation, which is mostly dependent on the physi- cian’s opinion, is the patient’s severe pain. It has been shown that early intubation of the patient due to severe pain can This open-access article distributed under the terms of the Creative Commons Attribution NonCommercial 3.0 License (CC BY-NC 3.0). Downloaded from: http://journals.sbmu.ac.ir/aaem 5 Archives of Academic Emergency Medicine. 2019; 7 (1): e35 improve hospitalization outcomes and reduce postoperative complications (12). This factor can be controlled by admin- istering appropriate analgesics to patients with trauma. In another study, among 120 intubated cases, half of them re- ceived strong painkillers, resulting in 3% of patients being subjected to intubation due to severe pain (13). The proba- bility of developing respiratory infections after intubation or ventilator-associated pneumonia (VAP) is another issue that is considered about early intubations. However, our study did not indicate the incidence of this problem. Evans et al. (14) also examined prehospital intubation of patients with trauma and showed that early intubation was not associated with an increased risk of VAP. Also in a review article, rapid intubation was recommed for traumatic patients (15). The rate of on arrival PCO2 is critical in traumatic patients and explicitly affects the outcome of patients (16). Another study assessed 890 intubated patients and found that on ar- rival hypercapnia and hypocapnia worsen the results of hos- pitalization in those who are intubated (17). Of course, this study examined patients with head trauma, but, we can con- clude that early intubation can be beneficial and lead to bet- ter regulation of blood gases and blood Pco2 in compari- son with control group. Early intubation of trauma patients, based on the physician’s opinion, is preferable to supportive care as it led to shorter hospitalization time, better recovery, and better VBG results. 5. Limitation The study limitations were small sample size and short dura- tion of subsequent follow-up. It could nonetheless be used as a guide for other studies with larger sample sizes and human- financial resources. 6. Conclusion Based on the findings of this study, the use of early intubation for patients with severe blunt trauma results in lower dura- tion of hospitalization and better acid/base balances without any hemodynamic and laboratory impairment. 7. Appendix 7.1. Acknowledgements We would like to thank Dr. Keyvan Ghadimi for helping us carry out this study. 7.2. Author contribution All authors met the four criteria for authorship contribution based on recommendations of the International Committee of Medical Journal Editors. Authors ORCIDs Mohammad Nasr-Esfahani: 0000-0002-5496-9170 Amir Bahador Boroumand: 0000-0001-5055-6881 Mohsen Kolahdouzan: 0000-0002-3095-6471 7.3. Funding/Support None. 7.4. Conflict of interest None. References 1. Ruchholtz S, Waydhas C, Ose C, Lewan U, Nast-Kolb D, Society WGoMTotGT. Prehospital intubation in se- vere thoracic trauma without respiratory insufficiency: a matched-pair analysis based on the Trauma Registry of the German Trauma Society. 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Journal of Trauma and Acute Care Surgery. 2012;73(5):S333-S40. 16. Thomas SH, Orf J, Wedel SK, Conn AK. Hyperventila- tion in traumatic brain injury patients: inconsistency be- tween consensus guidelines and clinical practice. Journal of Trauma and Acute Care Surgery. 2002;52(1):47-53. 17. Davis DP, Idris AH, Sise MJ, Kennedy F, Eastman AB, Velky T, et al. Early ventilation and outcome in patients with moderate to severe traumatic brain injury. Critical care medicine. 2006;34(4):1202-8. This open-access article distributed under the terms of the Creative Commons Attribution NonCommercial 3.0 License (CC BY-NC 3.0). Downloaded from: http://journals.sbmu.ac.ir/aaem Introduction Methods Results Discussion Limitation Conclusion Appendix References