Limitations and safety concerns related to the currently used cervical orthoses in preclinical emergency settings

doi:10.21203/rs.3.rs-2127682/v1

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Limitations and safety concerns related to the currently used cervical orthoses in preclinical emergency settings

https://doi.org/10.21203/rs.3.rs-2127682/v1

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Research question: Are the currently used cervical orthoses suitable for immobilizing the cervical spine for patients with preexisting ankylosing spondylitis, an anatomically short neck, or obesity?

Materials and Methods: Tools, immobilization methods, completion time, sagittal displacement, and feedback on result were compared for one control and two severe case scenarios simulated on appropriately built manikins. Scenario 1 simulated a young patient who sustained a bicycle fall with no fracture. Scenario 2 simulated a short-necked middle-aged patient who met a vehicle accident and showed C7/T1 bilateral facet dislocation fracture. Scenario 3 simulated an elderly patient with preexisting ankylosing spondylitis who fell down stairs and sustained a C6/C7 non-displaced fracture.

Results: For scenarios 1 and 2, the immobilization rate with the collar was 100% vs. 86%, average completion time was 90 s vs. 175 s, rate of attempts involving tool changes was 16% vs. 49%, rate of attempts with the collar forced in position was 0% vs. 32%, and proportion of cases with satisfactory results was 100% vs. 5%. For scenarios 1 and 3, the immobilization rate with the collar was 100% vs. 16%. For scenario 3, the rates of critical and highly critical sagittal deviation were 54% and 13.5%, respectively, while the efficiency of immobilization was 0%.

Discussion and conclusion: Currently used rigid collars can increase the time on-scene and tamper with spinal alignment. They cannot be easily and safely applied to elderly, overweight patients and those with an anatomically short neck and can diminish the outcomes for these patients.

Cervical immobilization

cervical collar

cervical orthoses

unstable cervical fracture.

Immobilization of the cervical spine is a general recommendation for cases involving a suitable trauma mechanism and/or the clinical impression of a cervical spine injury. [1–12] In such cases, immobilization is accomplished by using a rigid cervical collar.

Regardless of the cause, the resultant pathology is caused by two separate mechanisms: the primary injury mechanism, which can be attributed to the initial mechanical damage, and the secondary mechanism, which can be attributed to vascular and biochemical effects. [13–15] Medical history reports that up to 25% of cervical spine injuries occur after the initial injury, termed secondary injury, either during transport or in the early treatment course. [3, 16–18]

To our knowledge, the most used orthosis models are the StifNeck® Select™ (Laerdal Medical AS, Norway) and Ambu® Perfit ACE™ (Ambu A/S, Denmark). These types of orthoses are intended “to support the cervical spine in a neutral position” (Directions for Use, Stifneck® Select™) and “to assist with the maintenance of neutral alignment, prevention of lateral sway and anterior-posterior flexion and extension of the cervical spine” (Instructions for use, Ambu® Perfit ACE™). Both have a length of approximately 55 cm, minimum height of 11.5 cm, and slight anterior tilt of about 12°-14°. When applied around the neck, the immobilization is realized through a controlled strangulation. Most trials of prehospital spinal immobilization using these orthoses have been conducted on young, healthy volunteers. [19] Thus, their design seems to have been mainly developed for such patients.

Given these considerations, we hypothesized that these orthoses are insufficient, even harmful, for patients that are not “young and healthy,” including elderly patients with degenerative diseases of the cervical spine, overweight patients, or patients with a neck height shorter than 11.5 cm. We sought to analyze the problems that rescue specialists encounter when treating such patients, the solutions they employ, and the scope for improvement in managing future difficult cases. Our final aim was to improve the preclinical approach for the injured cervical spine, thereby improving the outcomes for this category of patients.

We conducted a detailed search of reports by local paramedics and emergency physicians as well as the medical literature to identify cases where problems were encountered.

From reports by local emergency physicians, we identified one severe case involving a patient who was injured in a vehicle accident and underwent several attempts to immobilize his neck using adult- and child-size orthoses at the accident site, with the patient being finally forced into an adult-sized orthosis. For this middle-aged patient, the diagnosis was a C7/T1 bilateral facet dislocation fracture with a chin-manubrium distance of only 84.7 mm with the orthosis in place.

The medical literature included two case reports [20, 21] of elderly patients with ankylosing spondylitis with neck pain and no neurological symptoms after minor indoor trauma. Both patients had a natural, flexed position of the head, and attempts to immobilize the neck and bring it to a neutral position influenced the subsequent neurological impairment. Immobilization with Gardner–Wells tongs [ 20] and a hard collar [21] put these patients in spinal shock, causing further degradation of their general status and their deaths at the 20th and 2nd day, respectively, after admission. The provided images [21] show no initial dislocation before immobilization and a massive dislocation of the fracture with the rigid collar in situ. Their external sagittal profile is best described by the illustration provided by Gowers. [22] Accordingly, we created a manikin for the ankylosing spondylitis scenario. Given the severity of these cases and the reported problems, the created manikins were of average adult size and simulated the biomechanical properties of the cervical spine in flexion and extension.

The manikin for the first scenario was designed as a control case, with a normal, neutral alignment of the head and neck and normal neck length. In this scenario, we simulated a bicycle fall of a young patient with multiple bruises and disorientation (GCS 14), but no fracture (Fig. 1a). For the second scenario, we simulated the conditions described in a case report by a local emergency physician: a middle-aged man injured in a vehicle accident, with full awareness, severely altered neurology below C7 due to the C7/T1 bilateral facet dislocation fracture, and an anatomically short neck. (Fig. 1b, c). In accordance with the ER imaging data, the manikin maintained a sagittal alignment and chin-manubrium distance of 85 mm (Fig. 1b). For the third scenario, we created a manikin based on the case described by Papadopoulos et al. [21], using the provided imaging and the quote “his line of vision was only a few paces ahead” and external sagittal profile from the illustration by Gowers. [22] This case involved an 82-year-old man with preexisting ankylosing spondylitis who sustained an injury after falling over a few steps. The patient remained conscious and fully alert after the fall; he did not exhibit or complain of any central or peripheral neurological impairment and only reported pain at the base of the neck, which was attributable to a C6/C7 non-displaced fracture (Fig. 1d, e, f).

These manikins were then presented to 43 teams of paramedics, each with two actively employed paramedics with an average field expertise of 11.6 years (range, 1 to 43 years), and the immobilization of the cervical spine was simulated, with the choice of abstaining from immobilization if it was considered dangerous to the patient. A single attempt per mannikin was allowed for each team.

The simulations took place in well-illuminated and appropriately climatized rooms. All the standard equipment on rescue vehicles were allowed, and the teams managed the scenarios according to their expertise and clinical recommendations. Completion time, method of immobilization, and change in the methods or tools were noted. The team’s own feedback regarding the satisfactoriness of the result was recorded. After completion, the results were photographically documented. To determine the degree to which immobilization achieved its purpose, a stability probe assessment was performed after every simulation. A series of three photos of the right profile of the manikin were taken. These photos were analyzed to determine the sagittal deviation of the manikin (Fig. 2).

Our algorithm used the anatomical dimensions of the cervical canal [23] and anatomical connections of the spinal cord, dura mater, and spinal bones and the fact that in the presence of pathological displacement, strain can exceed the material properties of the spinal cord. [24] Strain causing 12% elongation can cause a residual deficit and elongation of 20% will cause irreversible injury. [25] Thus, for example, for a “B3-Type Anterior Tension Band Injury” [26] at the C5/C6 level and a torsion point on the spino-laminar line [27] plus the abovementioned anatomical dimensions and properties of the cervical spine, we computed that an extension caused by an angulation of 14.8° of the head can produce a critical strain of the spinal cord at the injury level while an angulation of 24.6° can cause irreversible injury.

For the three scenarios, all 43 teams noted a clear indication to immobilize the cervical spine. All teams first used manual in-line stabilization, and the subsequent immobilization was completed as follows: Immobilization with a collar − 100% for scenario 1 (43 of 43 teams); 86% for scenario 2 (37 of 43 teams); and 16% (7 of 43) for scenario 3. Figure 3 shows the comparison of scenario 1 with 2.

The initial sagittal angulation was 14.5° in scenario 1, 14° for scenario 2, and 42.8° for scenario 3. Critical deviation over 14.8° from the start position was registered only during the immobilizations in scenario 3. For this scenario, most teams were reluctant to apply an orthosis from the start. Only seven teams used an orthosis as the primary method (16.3%), while the remaining 36 completed the immobilization with vacuum mattresses, spine boards, head blocks, improvised padding, and the Kendrick system. To assess the potential deviation with an orthosis, after their final method was documented, the teams were asked to try to apply a collar. From the 36 reluctant teams, 30 performed the procedure to the best of their ability. The results showed that a critical angulation of > 14.8° was recorded in 20 of 37 simulations, while highly critical angulation of > 24.6° was recorded in five simulations.

To quantitatively assess the efficiency of the immobilization, a stability probe was used after each simulation using an orthosis. Since the force generated across the spine by hanging a completely un-immobilized 4-kg head of the end of a stretcher is approximately 40 N [16], we tried to see how many of the simulations remain within the safety limit of 14.8° under this force. Thus, a forced 40 N extension and corresponding flexion was induced using a force gauge.

For scenario 2, 3 of 37 immobilizations with a collar reached a critical extension displacement, but none reached a highly critical one. For scenario 3, all 37 simulations reached critical extension, while 92% of extensions reached highly critical extension, with all of them showing an insufficient immobilization in 100% of the cases. The results are displayed in Fig. 4.

To complete our hypothesis that the height and length of the orthoses are responsible for the problems in obese patients, we asked a colleague, a 40-year-old man (weight, 125 kg; BMI, 38) to try both orthoses (Fig. 5, a-e).

We gently applied both orthoses to a colleague with no previous trauma to his cervical spine. He immediately reported discomfort even when the orthoses were carefully applied in their lowest height setting. The increased diameter and the circumference of his neck brought the dorsocervical plate of the orthoses about 8 cm (3 inch) forward, over his right trapezius muscle (Fig. 5a, b). Strapped on, only an asymmetric, incomplete, (Fig. 5c) closure of the orthoses was possible; thus, prevention of lateral sway became strongly questionable.

This asymmetric closure also caused a discomforting pressure over his right trapezius muscle and right collar bone. In sitting or standing positions, he estimated that the collars could be tolerated for up to 30 min. Since severely injured patients are transported laid on their back, we positioned him supine (Fig. 5d), and he immediately reported a further increase in pressure on his chin and right collar bone and an inability to open the mouth. He estimated a tolerance time under 1 minute. If such a patient should be intubated, the literature [28–32] strongly recommends a ramped position, aligning the patient`s sternal notch with the external auditory meatus. With the collar on, (Fig. 5e) this position further increased the discomfort and pressure in our colleague.

Our 86 paramedic colleagues followed the trauma protocol to the letter. Thus, the mechanism of injury was suitable and the patients showed clinical impressions of cervical spine injury, leaving the orthosis as the weak link.

For vehicle accident scenarios, which are inherently time-critical, in cases with an anatomically short neck the simulations showed that only two of the 43 teams were satisfied with the result; thus, 95% of the teams were not pleased with it. If such a patient becomes unconscious due to trauma or emergency general anesthesia, and muscle relaxants are used, this “forced in position” orthosis can severely temper the fracture.

Elderly patients are known to be predisposed to degenerative disorders of the cervical spine. [33, 34] These patients may sustain fractures even from minor, low-energy trauma, including trivial falls from a standing or sitting position. [34–38] Previous case reports describe the decompensations and lethal consequences of cervical immobilization for these patients. [20, 21] Some problems highlighted in these studies are as follows: 1) unlike young patients, these patients do not have a neutral position; and 2) these orthoses force the patient into hyperextension, thus compromising the spine cord. For the hyperkyphotic patient, 36 teams were reluctant to apply an orthosis from the beginning. Their experience disqualified these devices for this category of patients. Nevertheless, seven of the 43 teams applied an orthosis as the primary immobilization measure, thus highlighting the dangers of an inexperienced helper. Moreover, assessment of the possible sagittal deviation with such orthoses suggested that neurological damage would probably have been inflicted in 55% of the cases, which is highly concerning. The stability probe, with a 40-N pull-in flexion and corresponding extension, showed that leaving the head unsupported or using head blocks with a forehead strap could permit further extension of the head, which can potentially aggravate the injury. Therefore, immobilization with a rigid collar was inappropriate in all of these cases.

Increased neck circumference as well dorsocervical fat deposition can limit neck extension [28, 39], and when applied, these standard orthoses are not long enough for obese patients. We noticed lateralization of the dorso-cervical plate, and our colleague reported discomfort, pressure sites, and reduced time of tolerance, especially when the patient was laid on the back. For emergency physicians or paramedics, immobilization of obese patients with such orthoses may be associated with airway compromise by default. Since the interval between immobilization to clearing the cervical spine with imaging can easily be a few hours [3], forcing an awake overweight patient to wear such an orthosis for this length of time may not be realistic.

Given that the ideal criteria for a collar, i.e., “it must be radiographically translucent, be unobtrusive if access to the airway is necessary, not be hampered by varying weather conditions, be disposable of easily sanitized, fit a wide range of neck sizes, effectively restrict motion in the injured portion of the cervical spine, and be easily and rapidly applied without cervical motion at the scene of injury [40, 41],” were defined decades ago, the fact that so few of these criteria have been still fulfilled is disappointing. Since the collars have not changed, even if “cervical collars are known to be poorly applied, and it seems unlikely that a single design will be appropriate for all patients and all possible unstable injuries of the cervical spine” [42], the guidelines have changed and recommend more careful approaches for several categories of patients. A more individualized approach and appropriate precautions, especially for elderly patients, is recommended [43, 44], and the immobilization should be reversed if the patient shows neurological alterations [5].

Furthermore, imaging examinations are not available in a preclinical setting. Once a collar is applied, the site of injury can experience a concerning degree of displacement; thus, the first ER imaging assessment will provide an “as is,” not an “as it was” status. The trauma scene is not the time or the place for obtaining written informed consent, which mostly rules out randomized, controlled trials. Moreover, ethical approval of such a protocol for these patients is largely implausible. Thus, identification of the safest and fastest immobilization method in such cases must be principally based on the rescue specialist’s sound judgment, given the available tools, information from trials on healthy volunteers [19, 58] and case reports [20, 21], and the insights obtained from difficult scenarios training.

We believe that the problem lies with the tool, not the tactics. Complications such as discomfort, pain, pressure spikes, increased intracranial pressure, increased risk of aspiration [5, 16, 45–49], over distraction of the cervical spine [50], dislocation of the fracture [21], and delayed transport and loss of crucial time for patient outcomes [51] are mostly device-related complications that must be reduced. Although these devices can immobilize the spine through controlled strangulation, they are not an ideal tool or method of immobilization for several categories of patients. Devices that allow a peak angular displacement over 40°, even when correctly fitted [52], cannot be considered efficient devices. New devices that are more easy, safe and effective to use were recommended many years ago. [3, 53 54] The human anatomy has not changed, the spinal canal and spinal cord have a very limited tolerance to displacement. [55–57] Most importantly, the patient should not be harmed as a result of using an inappropriate device.

We can presume that these orthoses, with a fixed length and minimum height of 11.5 cm and an industrial design to sustain the neutral position of the neck, were designed and tested mostly on young, healthy volunteers. [19] Therefore, they can still be used on young, healthy patients. For elderly patients, overweight individuals, patients with an anatomically or trauma-induced short neck, and those with degenerative disorders of the cervical spine, we recommend alternative methods of immobilization in case of an unstable fracture. We also recommend that the producers of these devices consult rescue specialists to develop better, easier to use, and more efficient tools.

ATLS Advanced Trauma Life Support

AWMF Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften /Working Group of the Scientific Medical Society

BMI Body Mass Index

C5/C6/C7 Cervical 5th, 6th, and 7th vertebrae

DGU Deutsche Gesellschaft für Unfallchirurgie/German Society for Trauma Surgery

ER Emergency Room

GCS Glasgow Coma Scale

N Newton

PHTLS PreHospital Trauma Life Support

T1 Thoracic first vertebrae

Conflicts of interest

The authors declare that there are no conflicts of interest of any kind.

Acknowledgments

We would like to thank the paramedics of the Bavarian Red Cross and Bavarian Cross of Malta from Deggendorf and Straubing counties who participated in this study. Without their experience and participation, our study would have not been possible. We also remain greatly indebted to the Radiology Departments of the Donau-Isar-Klinikum Deggendorf and Klinikum St. Elisabeth Straubing for providing us the case reports with the corresponding imaging data.

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Limitations and safety concerns related to the currently used cervical orthoses in preclinical emergency settings

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