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CAMPUS BOX F-490 TELEPHONE: 303-724-1055 Fax: 303-724-0990
Protocol #: 22-1625
Project Title: Assessment of prehospital airway placements in the setting of trauma: An American Association for the Surgery of Trauma multicenter study
Principal Investigator: Shane Urban, BSN, RN, CCRC
Co-Investigators: Michael Cripps, MD; Catherine Velopulos, MD
Version Date: 08/01/2022
I. Hypotheses and Specific Aims
Hypotheses:
After propensity score matching, patients that undergo prehospital endotracheal intubation (EMS ETT) will experience mortality more frequently than patients that have definitive airway management after emergency department (ED) arrival.
Patients that have supraglottic airway management in the field (oropharyngeal, nasopharyngeal, laryngeal mask airways [LMA], etc.) will spend less time on scene and experience mortality less frequently than those patients with EMS ETT attempts regardless of injury severity.
Specific Aims
Determine the mortality rate of patients that undergo EMS ETT compared to those that are intubated post ED arrival.
Identify the rate of successful EMS ETT rate in those attempted.
Determine which airway management technique has the highest success rate in prehospital arena for patients experiencing acute trauma.
II. Background and Significance
One of the first priorities in trauma care is the confirmation of a patent airway ADDIN EN.CITE Mayglothling201222(Mayglothling et al., 2012)222217Mayglothling, J.Duane, T. M.Gibbs, M.McCunn, M.Legome, E.Eastman, A. L.Whelan, J.Shah, K. H.Virginia Commonwealth University Medical Center, Richmond, Virginia, USA. jmayglothling@mcvh-vcu.eduEmergency tracheal intubation immediately following traumatic injury: an Eastern Association for the Surgery of Trauma practice management guidelineJ Trauma Acute Care SurgJ Trauma Acute Care SurgS333-40735 Suppl 42012/11/09Airway Management/methods/standardsEmergency Medical Services/methods/standardsHumansIntubation, Intratracheal/methods/*standardsWounds and Injuries/*therapy2012Nov2163-07552311449010.1097/TA.0b013e31827018a5NLMeng(Mayglothling et al., 2012), and endotracheal intubation is considered the gold-standard for definitive airway management ADDIN EN.CITE ADDIN EN.CITE.DATA (Carney et al., 2021; Pepe et al., 2015). Both the American College of Surgeons (ACS) and the National Association of Emergency Medical Technicians (NAEMT) recommend early prehospital endotracheal intubation or surgical cricothyrotomy if there is any doubt a patient may not be able to protect their own airway ADDIN EN.CITE ADDIN EN.CITE.DATA (Tsur et al., 2020).
Despite its ubiquitous presence in the prehospital arena, EMS ETT is a controversial topic. The controversy is particularly pronounced for patients experiencing acute traumatic injury. While some literature exists that supports EMS ETT for patients with traumatic brain injury ADDIN EN.CITE ADDIN EN.CITE.DATA (Denninghoff et al., 2017; Gamberini et al., 2019), there is mounting evidence that PHI is detrimental for the majority of trauma patients. In 2017 Fevang et al. did a large systematic review and meta-analysis comparing the mortality rate of trauma patients that underwent EMS ETT vs. those that were intubated upon emergency department (ED) arrival. Their analysis consistently demonstrated that EMS ETT patients had a higher odds of mortality compared to trauma patients that had definitive airway management upon ED arrival ADDIN EN.CITE ADDIN EN.CITE.DATA (Fevang et al., 2017).
However, a more recent systematic review by Carney et al. (2021) noted that there was insufficient evidence to suggest any differences in patient-centered outcomes when comparing various prehospital airway management techniques such as bag-valve-mask, supraglottic airways, and EMS ETT. The lack of sufficient evidence may be secondary to numerous factors, including: differences in prehospital staffing, the presence of absence of rapid sequence intubation, and differing prehospital treatment algorithms ADDIN EN.CITE ADDIN EN.CITE.DATA (Carney et al., 2021; Gamberini et al., 2019). These findings are reflected in the 2012 Eastern Association for the Surgery of Traumas Endotracheal Intubation Guidelines. EASTs guidelines were unable to provide recommendations regarding EMS ETT given secondary to insufficient evidence ADDIN EN.CITE Mayglothling201222(Mayglothling et al., 2012)222217Mayglothling, J.Duane, T. M.Gibbs, M.McCunn, M.Legome, E.Eastman, A. L.Whelan, J.Shah, K. H.Virginia Commonwealth University Medical Center, Richmond, Virginia, USA. jmayglothling@mcvh-vcu.eduEmergency tracheal intubation immediately following traumatic injury: an Eastern Association for the Surgery of Trauma practice management guidelineJ Trauma Acute Care SurgJ Trauma Acute Care SurgS333-40735 Suppl 42012/11/09Airway Management/methods/standardsEmergency Medical Services/methods/standardsHumansIntubation, Intratracheal/methods/*standardsWounds and Injuries/*therapy2012Nov2163-07552311449010.1097/TA.0b013e31827018a5NLMeng(Mayglothling et al., 2012).
The purpose of this study is to explore the use of various prehospital airway management techniques in a sample of acutely injured patients. The outcomes of this study could allow organizations such as the American Association for the Surgery of Trauma, the Eastern Association for the Surgery of Trauma, and the Western Trauma Association to make more firm guidelines regarding the optimal care of the injured patient.
IV. Research Methods
This study will be a multicenter, retrospective, observational study sponsored by the American Association for the Surgery of Trauma. All participating centers will submit data directly into a Research Electronic Data Capture (REDCap) database hosted by the University of Colorado, Denver.
B. Description of Population to be enrolled.
Inclusion Criteria:
Patients that have any prehospital airway attempted. Including: endotracheal intubation, supraglottic airways, oropharyngeal airways, nasopharyngeal airways, and bag-vale-ventilation.
All patients that have intubation attempted in the ED within 60 minutes of hospital arrival regardless of prehospital airway device placement.
All patients who have a surgical airway placed within 60 minutes of arrival to Emergency Department
Transported from the scene of injury by aeromedical or ground ambulance
Exclusion criteria:
Pregnant patients
Patients < 18 years-old
Any patients transported from a correctional facility
Inter-facility transfers
No Emergency Medical Services (EMS) trip sheet available
C. Study Design and Research Methods.
This study is a multicenter, retrospective, observational design. The study will be coordinated by the University of Colorado, Denver. Each participating center will gain IRB approval from their respective IRBs and establish DUAs prior to data sharing.
The duration of the study will be approximately 24 months. The first 12 months will be spent recruiting centers, collecting IRB approvals, and establishing DUAs. The second 12 months will be spent collecting data. Some centers may get IRB approval and establish a DUA more promptly than others. In those cases, centers will be able to submit data prior to the conclusion of the first 12 months. This study will collect data from 01/01/2020-12/31/2021.
The following data elements will be submitted via a study specific REDCap hosted by the University of Colorado, Denver.
Demographic Data:
Age
Gender
Ethnicity
Race
Height
Weight
Prehospital Data:
Prehospital staffing physician, registered nurse, paramedic, or emergency medical technicians (EMT)
EMS vehicle helicopter or ground ambulance
First recorded prehospital vital signs systolic blood pressure, pulse, respiratory rate, Glasgow Coma Scale (GCS), oxygen saturation, end tidal carbon dioxide.
Lowest recorded prehospital vital signs - systolic blood pressure, pulse, respiratory rate, Glasgow Coma Scale (GCS), oxygen saturation, end tidal carbon dioxide.
Mode of response lights and sirens (emergent) vs. no lights and sirens (non-emergent)
Mode of transport lights and sirens (emergent) vs. no lights and sirens (non-emergent)
Presence of a documented scene delay patient extrication, scene safety, patient access, etc.).
EMS procedures Intravenous access, medication administration, wound care, immobilization, pelvic binder, extremity splinting, physical restraints, tourniquet placement, needle decompression, intraosseous access, other.
Bag-valve-mask ventilation
Airway suctioning
Oropharyngeal airway (OPA) placement
Nasopharyngeal airway (NPA) placement
EMS ETT attempt/success
Type of EMS ETT nasal intubation vs. oral intubation
Prehospital surgical cricothyrotomy
Prehospital supraglottic airway
Prehospital rapid sequence intubation/drug-assisted
Total number of EMS procedures
Date and time of EMS dispatch
Date and time of EMS arrival on scene
Date and time EMS initiated transport
Date and time of EMS arrival to the ED
EMS scene time (calculated value)
EMS transport time (calculated value)
Total time patient spent in the field (calculated value)
Distance from the receiving facility as documented in the EMS trip-sheet or Google Maps
Injury Data:
Mechanism penetrating, blunt, thermal
Specific injury gunshot wound, stabbing, motor vehicle accident, etc.
Suspected upper airway injury injury to a patients airway above the glottis.
If applicable, zone of neck injury (I, II, or III).
Hospital Arrival Data:
First recorded ED arrival vital signs systolic blood pressure, pulse, respiratory rate, Glasgow Coma Scale (GCS), oxygen saturation, end tidal carbon dioxide.
Initial hospital procedures blood product administration, chest tube placement, central venous access, thoracotomy, REBOA, tourniquet
Dates and times of initial hospital procedures
ED disposition operating room, Intensive Care Unit (ICU), non-ICU admission, morgue.
Date and time of ED disposition
Total emergency department length of stay (calculated value)
Endotracheal intubation upon arrival
Rapid sequence intubation/drug-assisted intubation
Number of ED intubation attempts
If the patient was intubated by prehospital providers, was the intubation determined to be successful or unsuccessful upon ED arrival.
If applicable, what was the reason the patient was intubated both in the field and upon ED arrival (i.e., misplaced EMS intubation, EMS tube dislodgement, or endotracheal tube exchange).
Surgical cricothyrotomy
Outcomes data:
Injury severity score
Maximum Abbreviated Injury Scale (AIS) for each AI S r e g i o n
A I S h e a d r e g i o n e" 3 ( n o t t o i n c l u d e A I S n e c k s c o r e s )
D a y s s p e n t o n v e n t i l a t o r ( c a l e n d a r d a y s )
M o r t a l i t y
H o s p i t a l d i s p o s i t i o n
4 h o u r a n d 2 4 b l o o d p r o d u c t t o t a l s r e c o r d e d i n m i l l i l i t e r s , i f a p p l i c a b l e
H o s p i t a l d i s p o s i t i o n h o m e , h o m e h e a l t h , l o n g term care facility, skilled nursing facility, morgue
Date and time of hospital discharge
Total hospital length of stay (calculated field)
Total ICU length of stay (calendar days)
Ventilator associated pneumonia (National Trauma Data Standard [NTDS] data element)
Unplanned intubation (National Trauma Data Standard [NTDS] data element)
Acute respiratory distress syndrome (National Trauma Data Standard [NTDS] data element)
Severe sepsis (National Trauma Data Standard [NTDS] data element)
D. Description, Risks, and Justification of Procedures and Data Collection Tools.
The only risk associated with this retrospective observational study is the risk of a breach of confidentially. This risk will be minimized in the following ways:
Data will be securely stored in REDCap.
Only the lead site will have access to all data.
Only a limited dataset is being collected from each center. The only PHI being various dates and times used for different time interval calculations (no dates and times will exported from REDCap)
Data will only be exported from REDCap without identifiers.
Findings will only be reported in aggregate.
The risk associated with this study is justified as there needs to be recommendations from trauma experts with regards to how airway compromise should be managed in the prehospital setting. The findings of this study could lead to improved policies, procedures, and patient care.
This study will have a waiver of informed consent given that it is no greater than minimal risk, and does not impact the rights or welfare of subjects. Additionally, many patients may expire secondary to the injuries and may be incapable of providing consent.
E. Potential Scientific Problems.
Since this study is observational only, no causative relationships will be made. We will only be able to make certain correlations.
F. Data Analysis Plan.
This exploratory data analysis will employ a number of techniques to both describe trauma patients that undergo various airway management techniques as well as compare different cohorts to determine the optimal management of trauma patients with airway compromise.
Categorical data will be analyzed using Chi squared or Fishers Exact test as appropriate. Continuous data elements will be assessed using Students T-Test or Wilcoxon Rank-Sum depending on normal distribution vs. non-normal distribution.
A l l v a r i a b l e s w i t h a p - v a l u e d" 0 . 2 o n u n i v a r i a t e a n a l y s i s w i l l b e e n t e r e d i n t o s t e p w i s e m u l t i v a r i a t e r e g r e s s i o n t o d e t e r m i n e f a c t o r s a s s o c i a t e d w i t h P H I s u c c e s s / f a i l u r e . A d d i t i o n a l l y , m u l t i v a r i a b l e r e g r e s s i o n a n a l y s i s w i l l b e e m p l o y e d t o c o m p a r e f a c t o r s a s sociated with survival/mortality.
G. Summarize Knowledge to be Gained
H. References
ADDIN EN.REFLIST Carney, N., Totten, A. M., Cheney, T., Jungbauer, R., Neth, M. R., Weeks, C., Davis-O'Reilly, C., Fu, R., Yu, Y., Chou, R., & Daya, M. (2021). Prehospital Airway Management: A Systematic Review. Prehosp Emerg Care, 1-12. HYPERLINK "https://doi.org/10.1080/10903127.2021.1940400" https://doi.org/10.1080/10903127.2021.1940400
Denninghoff, K. R., Nuo, T., Pauls, Q., Yeatts, S. D., Silbergleit, R., Palesch, Y. Y., Merck, L. H., Manley, G. T., & Wright, D. W. (2017). Prehospital Intubation is Associated with Favorable Outcomes and Lower Mortality in ProTECT III. Prehosp Emerg Care, 21(5), 539-544. HYPERLINK "https://doi.org/10.1080/10903127.2017.1315201" https://doi.org/10.1080/10903127.2017.1315201
Fevang, E., Perkins, Z., Lockey, D., Jeppesen, E., & Lossius, H. M. (2017). A systematic review and meta-analysis comparing mortality in pre-hospital tracheal intubation to emergency department intubation in trauma patients. Crit Care, 21(1), 192. HYPERLINK "https://doi.org/10.1186/s13054-017-1787-x" https://doi.org/10.1186/s13054-017-1787-x
Gamberini, L., Baldazzi, M., Coniglio, C., Gordini, G., & Bardi, T. (2019). Prehospital Airway Management in Severe Traumatic Brain Injury. Air Med J, 38(5), 366-373. HYPERLINK "https://doi.org/10.1016/j.amj.2019.06.001" https://doi.org/10.1016/j.amj.2019.06.001
Mayglothling, J., Duane, T. M., Gibbs, M., McCunn, M., Legome, E., Eastman, A. L., Whelan, J., & Shah, K. H. (2012). Emergency tracheal intubation immediately following traumatic injury: an Eastern Association for the Surgery of Trauma practice management guideline. J Trauma Acute Care Surg, 73(5 Suppl 4), S333-340. HYPERLINK "https://doi.org/10.1097/TA.0b013e31827018a5" https://doi.org/10.1097/TA.0b013e31827018a5
Pepe, P. E., Roppolo, L. P., & Fowler, R. L. (2015). Prehospital endotracheal intubation: elemental or detrimental? Crit Care, 19(1), 121. @ 1 2 J d e ղkZ h-Q hO CJ OJ QJ ^J aJ &h-Q hYo 5>*CJ OJ QJ ^J aJ hYo h