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Pediatric Tourniquet Types: First Aid New TF SR

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This CoSTR is a draft version prepared by ILCOR, with the purpose to allow the public to comment and is labeled “Draft for Public Comment". The comments will be considered by ILCOR. The next version will be labelled “draft" to comply with copyright rules of journals. The final COSTR will be published on this website once a summary article has been published in a scientific Journal and labeled as “final”.

Conflict of Interest Declaration

The ILCOR Continuous Evidence Evaluation process is guided by a rigorous ILCOR Conflict of Interest policy. The following Task Force members and other authors were recused from the discussion as they declared a conflict of interest: none applicable

The following Task Force members and other authors declared an intellectual conflict of interest and this was acknowledged and managed by the Task Force Chairs and Conflict of Interest committees: None applicable

CoSTR Citation

Charlton NP, Goolsby CA, Zideman DA, Maconochie IK, Morley PT, Singletary EM. Appropriate Tourniquet Types in the Pediatric Population: A Systematic Review. Cureus. 2021 Apr 13;13(4):e14474. doi: 10.7759/cureus.14474. PMID: 33996333; PMCID: PMC8118807

Collaborators: Jason Bendall, David Berry, Vere Borra, Richard Bradley, Jestin N Carlson, Pascal Cassan, Wei-Tien Chang, Therese Djärv, Matthew Douma, Jonathan L Epstein, Daniel Meyran, Michael Nemeth, Aaron Orkin, Peter Morley

  1. Disclaimer: This article is the opinion of the authors and does not reflect the official policy or position of the Uniformed Services University, Defense Department, or US Government.

Methodological Preamble (and Link to Published Systematic Review if applicable)

The continuous evidence evaluation process for the production of Consensus on Science with Treatment Recommendations (CoSTR) started with a systematic review of first aid interventions for control of life-threatening bleeding {Charlton 2020 1} and a scoping review of the use of tourniquets in the pediatric population (<19 years of age){Singletary 2020 S284; Singletary 2020 A240}. This led to a recommendation for a systematic review (PROSPERO CRD42021229767) conducted by Nathan Charlton and Craig Goolsby of the First Aid Task Force and Ian Maconochie of the Pediatric Life Support Task Force. Evidence for pediatric literature was sought and considered by the First Aid Task Force and the Pediatric Task Force groups respectively. These data were taken into account when formulating the Treatment Recommendations.

PICOST

The PICOST (Population, Intervention, Comparator, Outcome, Study Designs and Timeframe)

Population: In children (less than 19 years of age) with severe, life-threatening bleeding from an extremity wound

Intervention: commercial elastic wrap tourniquet or commercial ratcheting tourniquet

Comparators: commercial windlass rod-type tourniquet

Outcomes: Primary outcomes: mortality (critical), control of bleeding (critical), blood loss (critical), shock/hypotension (critical), adverse events (important).

Study Designs: Randomized controlled trials (RCTs) and non-randomized studies (non-randomized controlled trials, interrupted time series, controlled before-and-after studies, cohort studies) and case series are eligible for inclusion. Unpublished studies (e.g., conference abstracts, trial protocols), modeling studies, studies of tourniquets applied solely to maintain as bloodless surgical field, or those relating only to education were excluded.

Timeframe: All years and all languages were included as long as there was an English abstract; unpublished studies (e.g., conference abstracts, trial protocols) were excluded.

Submitted to PROSPERO, Registration pending.

Risk of bias and certainty of the evidence

Confidence in the estimate of effect for the outcomes evaluated was decreased due to the serious risk of bias, indirectness and imprecision. For the outcomes of control of bleeding and adverse events, data was found from two observational trials. Serious bias was introduced due to confounding. Researchers applied all tourniquets in a medical setting in uninjured extremities of a convenience sample of pediatric participants. An insufficient number of studies were found to evaluate for publication bias.

Consensus on Science

  • For the critical outcome of control of bleeding, no studies were identified that compared the use of one tourniquet type with another tourniquet type on injured children less than 19 years of age. A surrogate outcome for control of bleeding was the cessation of distal pulse as detected by Doppler ultrasound.

We identified two observational studies conducted in a medical setting providing indirect evidence of very low certainty (downgraded for risk of bias, indirectness and impression) enrolling a total of 73 children 2-16 years old.{Harke2019 e20183447; Kelly 2020 644} Studies were conducted while children were visiting an orthopedic office (n=60; age 6-16 years) {Harke 2019 e20183447} or while under anesthesia in an operating room (n=13; age 2-7 years) {Kelly 2020 644}. All children had a windlass rod tourniquet (Combat Application Tourniquet Generation 7) applied to an uninjured extremity by the researchers to evaluate the outcome of cessation of pulses. Pooled data showed cessation of pulses in 71/71 (100%) upper extremities and in 69/73 (94.5%) of lower extremities after the application of the windlass rod tourniquet. The four tourniquet failures were secondary to inability to continue secondary to pain (n=1) and inability to occlude the distal pulse after a prespecified three windlass turn maximum (n=3). {Harke 2019 e20183447} No controls were included in either study for comparison.

  • For the important outcome of adverse events, no studies were identified that compared one tourniquet type with another tourniquet type in children less than 19 years of age. We identified one observational study {Harke 2019 e20183447} with very low certainty evidence (downgraded for bias, indirectness and imprecision) enrolling a total of 60 children ages 6-16 years, reporting adverse events with the application of a windlass rod tourniquet when it was used to evaluate cessation of distal pulses in uninjured extremities. This study reported one adverse event in the 120 applications of the tourniquet to upper (n=60) and lower (n=60) extremities. During tourniquet tightening, one child (unknown age) experienced enough pain to halt application of the tourniquet. No other adverse events were reported.
  • No studies were found for the outcomes of mortality, blood loss, and shock/hypotension.

Treatment Recommendations

We suggest the use of a manufactured windlass tourniquet for the management of life-threatening extremity bleeding in children. (weak recommendation, very low certainty of evidence)

We are unable to recommend for or against other tourniquet types in children due to lack of evidence.

For infants and children with extremities that are too small to allow the snug application of a tourniquet before activating the circumferential tightening mechanism, we recommend the use of direct manual pressure with or without the application of a hemostatic trauma dressing. (Good practice statement)

Technical remarks:

In both studies included, the Combat Application Tourniquet Generation 7 was the specific brand of windlass rod tourniquet used.

The included studies evaluated tourniquet use on children from 2 years to 16 years of age with a minimal limb circumference of 13 cm.

For the purpose of this review, the pediatric age of 18 and younger was chosen by the First Aid and Pediatrics Task Force and is the same as used in a previous scoping review by ILCOR.

Justification and Evidence to Decision Framework Highlights

This topic was prioritized by the First Aid Task Force. Previous reviews of adult and pediatric literature identified experimental studies of tourniquet use in pediatric models such as PVC pipes that demonstrated failure of adult tourniquets on smaller pipe sizes.{El-Sherif 361} A scoping review {Singletary 2020 S284, Singletary 2020 A240} identified emerging evidence from human studies of tourniquet use in children which was incorporated in this review.

In making this recommendation, the First Aid Task force considered the following:

  • There is a lack of direct evidence demonstrating that tourniquets are a life-saving treatment for life-threatening bleeding in children. However, the First Aid Task Force values the previously established role of a manufactured windlass tourniquet in reducing mortality in adults with life-threatening bleeding. {Charlton 2020 1} The Task Force relied heavily on these adult studies to infer that tourniquets would also be lifesaving for life-threatening bleeding in children.
  • There is a lack of direct comparative evidence for the best tourniquet types in children and infants. In formulating treatment recommendations, the Task Force relied on data from two observational studies in healthy pediatric participants. {Harke 2019 e20183447, Kelly 2020 644}. In these studies, a windlass rod style tourniquet, specifically the Combat Application Tourniquet Generation 7 in both studies, was able to occlude distal blood flow in both the upper and lower extremities in children as young as two years of age with a minimum limb circumference of 13 cm.
  • In the two studies included, the Combat Application Tourniquet Generation 7 was the specific brand of windlass rod tourniquet used. Other windlass rod tourniquets may vary in their ability to tighten successfully in small limb diameters. While some data is available from manikin studies, these studies were felt to be too indirect to include. {El-Sherif 2019 361, Kragh 2019 41} In accordance with prior recommendations, if an available tourniquet fails to tighten enough to control distal bleeding, direct pressure with the use of a hemostatic dressing should be used to obtain bleeding control. {Charlton 2020 1}
  • There is no human evidence for the use of either manufactured or improvised tourniquets in children less than 2 years of age. It is the expert opinion of the Task Force that for children less than two years of age, body size and a lower relative pressure would likely make direct manual pressure more efficacious than in adults. Therefore, direct pressure should be used to treat life-threatening extremity bleeding in children less than 2 years of age. Based on extrapolation from adult literature, this should be applied with a hemostatic dressing, if available. {Charlton 2020 1} While it may be difficult for providers to determine whether a child is two years or older, the Task Force discussed that the typical habitus of a toddler, rather than an infant could be used to help make this determination.
  • The only reported adverse effect reported was pain in one child in one study. {Harke 2019 e20183447} This is consistent with studies of adult tourniquets and is an expected effect of tourniquet application {Charlton 2020 1}.
  • Inflicting pain in a volunteer study in the pediatric population would be unethical, and therefore, understandably there was a failure of the application of the tourniquet to occlude distal pulses in this study as the force required to do so could cause pain {Harke 2019 e20183447}. The Task Force acknowledges that the survival benefit of tourniquet use in life-threatening bleeding outweighs the risk of pain in both pediatric and adult populations.

Knowledge Gaps

  • There is an urgent need for comparative RCTs in the prehospital setting to determine which tourniquet designs produce beneficial outcomes in the pediatric population
  • Additional human studies are needed to determine both the lower age and size limits in which these tourniquets can be applied to both upper and lower extremities to enable hemorrhage control
  • Studies are needed to identify all the complications of tourniquet use in children
  • Further studies are needed to determine the efficacy and rapidity of application of tourniquets on children by first aid providers.

Attachment

Et D-Peds-TQ_revised

References

  1. Charlton NP, Swain JM, Brozek JL, Ludwikowska M, Singletary E, Zideman D, Epstein J, Darzi A, Bak A, Karam S, Les Z, Carlson JN, Lang E, Nieuwlaat R. Control of Severe, Life-Threatening External Bleeding in the Out-of-Hospital Setting: A Systematic Review. Prehosp Emerg Care. 2020 Apr 27:1-33. doi: 10.1080/10903127.2020.1743801. Epub ahead of print. PMID: 32208060.
  2. El-Sherif N, Lowndes B, Franz W, Hallbeck MS, Belau S, Sztajnkrycer MD Sweating the Little Things: Tourniquet Application Efficacy in Two Models of Pediatric Limb Circumference. Mil Med. 2019 Mar 1;184(Supplement_1):361-366. doi: 10.1093/milmed/usy283.
  3. Harcke HT, Lawrence LL, Gripp EW, Kecskemethy HH, Kruse RW, Murphy SG. Adult Tourniquet for Use in School-Age Emergencies. Pediatrics. 2019 Jun;143(6):e20183447. doi: 10.1542/peds.2018-3447. Epub 2019 May 7. PMID: 31064797.
  4. Kelly JR, Levy MJ, Reyes J, Anders J. Effectiveness of the combat application tourniquet for arterial occlusion in young children. J Trauma Acute Care Surg. 2020 May;88(5):644-647. doi: 10.1097/TA.0000000000002594. PMID: 31977996.
  5. Kragh JF Jr, Wright-Aldossari B, Aden JK 3rd, Dubick MA.J Ease of Use of Emergency Tourniquets on Simulated Limbs of Infants: Deliberate Practice. Spec Oper Med. 2019 Summer;19(2):41-47.
  6. Singletary EM, Zideman DA, Bendall JC, Berry DC, Borra V, Carlson JN, Cassan P, Chang WT, Charlton NP, Djärv T, Douma MJ, Epstein JL, Hood NA, Markenson DS, Meyran D, Orkin AM, Sakamoto T, Swain JM, Woodin JA; First Aid Science Collaborators. 2020 International Consensus on First Aid Science With Treatment Recommendations. Circulation. 2020 Oct 20;142(16_suppl_1):S284-S334. doi: 10.1161/CIR.0000000000000897. Epub 2020 Oct 21. PMID: 33084394.
  7. Singletary EM, Zideman DA, Bendall JC, Berry DA, Borra V, Carlson JN, Cassan P, Chang WT, Charlton NP, Djärv T, Douma MJ, Epstein JL, Hood NA, Markenson DS, Meyran D, Orkin A, Sakamoto T, Swain JM, Woodin JA, De Buck E, De Brier N, O D, Picard C, Goolsby C, Oliver E, Klaassen B, Poole K, Aves T, Lin S, Handley AJ, Jensen J, Allan KS, Lee CC; First Aid Science Collaborators. 2020 International Consensus on First Aid Science With Treatment Recommendations. Resuscitation. 2020 Nov;156:A240-A282. doi: 10.1016/j.resuscitation.2020.09.016. Epub 2020 Oct 21. PMID: 33098920.
First Aid
Emergency care

Discussion

Виктория Антонова
(397 posts)

(modified: )

Consider a broader recommendation than "There is an urgent need for comparative RCTs in the prehospital setting to determine which tourniquet designs produce beneficial outcomes in the pediatric population", such as an RCT of applying tourniquet designs and measuring time to pulselessness distal to the tourniquet.
Reply
David Zideman
(6 posts)

(modified: )

Thank you for the comment. The Task Force acknowledge that there are a wide range of different studies that could be undertaken but that it would be difficult to list all of these in this systematic review.
Виктория Антонова
(397 posts)

(modified: )

There is no evidence that any of the current designs available for children is problematic or has resulted clinically in inadequate bleeding control. Since research bandwidth is necessarily limited, the question of the efficacy of one tourniquet design relative to another does not seem to rise to the level of warranting research funding investment. Studies outlining the scope of the clinical problem to be solved or demonstrating evidence of any clinical failure of existing treatment methodologies should precede any further investment in studies addressing the comparative effectiveness of one commercial brand of tourniquet or one commercial tourniquet design over another.
Reply
David Zideman
(6 posts)

(modified: )

Thank you for your comment. The Task Force has considered your comment and agree that there is less data in the pediatric population on the scope of life threatening extremity bleeding in the pre-hospital population and we would agree that further research is needed on this topic. However, it cannot be assumed that all tourniquets, even those “designed” for the pediatric population work in the pediatric population. Some modelling studies (El-Sheif 2019, Vretis 2018) suggest otherwise and it is important that published scientific evidential research supports the use of these life-saving interventions.
Виктория Антонова
(397 posts)

(modified: )

Consider adding in the pediatric trauma society position statement on this topic https://pubmed.ncbi.nlm.nih.gov/29462083/ Also consider statement about training in application and availability
Reply
David Zideman
(6 posts)

(modified: )

Thank you for the comment. Based on primarily military data, the Task Force believes that tourniquets will save lives when used for life-threatening extremity bleeding in the pediatric population. However, the Task Force did not feel that it was necessary to include statements from either the Pediatric Trauma Society or the Committee for Tactical Emergency Casualty Care Pediatric Working Group in this consensus on science, although they may be considered in the introduction or discussion of an accompanying systematic review manuscript. While commentary on the application or availability of tourniquet devices is not specifically made within the Consensus on Science, it was discussed by the Task Force as part of the evidence to decision process and included in the Evidence to Decision table under resources required, cost effectiveness, equity, acceptability and feasibility.
Виктория Антонова
(397 posts)

(modified: )

Would appreciate if you consider use of improvised tourniquets (TQs) in this study or future study and also about the width of TQs.
Reply
David Zideman
(6 posts)

(modified: )

The Task Force thanks you submitting your comment.
Виктория Антонова
(397 posts)

(modified: )

Conflicts of interest: Other financial entities
Although there are limited studies, there is information about how small both the CAT (windlass) and the RMT (ratcheting) tourniquets can go, and therefore be used in small children. The CAT-6 and CAT-7 can be use on an extremity as small as 5.2 in (13.1 cm) in circumference _approx. forearm of a 4-6month old child. The ratcheting Medical Tourniquet (RMT) has a pediatric size for those less than 120 lbs 955 kg) that can be used in an extremity as small as 4.4in (11 cm)- forearm of a 0-3 month old. References Engel WT, Otting M: procedure 25: Tourniquet application in : Fuchs S, McEvoy M, eds. pediatric Education for Prehospital Professionals, 4th ed, Burlington, MA: Jones & Bartlett learning 2021:441-444. Ross EM, Bolleter S, Simon E, et al. Pediatric extremity hemorrhage and tourniquet use. J Emerg Med Services 2018: 1. Kelly JR, Levy MJ, Reyes J, et al. (your ref 4) Effectiveness of the combat application tourniquets for arterial occlusion in young adults. J trauma Acute Care Surg 2020;88:644-647. A study done on pediatric war casualties ( Kragh JF Jr, Cooper A, Aden JK et al, Survey of trauma registry data on tourniquet use in pediatric war casualties. Pediatr Emerg Care 2012:28:1361-1365) demonstrated improved survival
Reply
David Zideman
(6 posts)

(modified: )

Thank you for submitting your comment. The Task Force agrees that while most of the data, as you cite, is from military evidence (Sokol 2015, Kragh 2012), the use of tourniquets for life threatening extremity hemorrhage will improve survival in the pediatric population (Callaway 2017). This review was performed using GRADE methodology, with inclusion of studies performed on humans. Modeling studies (El-Sherif 2019, Kragh 2019 and Vretis 2018) performed on plastic manakins, ballistics gel with rubber tubing, or stair rails were not included in this systematic review but were described in the Evidence to Decision Table. The Task Force expressed concern as to how the rigidity of the plastic or metal equates to human tissue or how the outcomes of “tightness” or compressing rubber tubing equate to stopping human blood flow from potentially large, difficult to compress, arteries. In addition, in the most robust of these studies (El-Sherif 2019), the task force was unable to interpret the clinical utility of certain definitions, such as “windlass enabled pass”. While the Harke and Kelly studies also used an indirect outcome, abolishing distal pulses in uninjured extremities, these studies were performed on children instead of models, allowing their inclusion in the review and subsequent treatment recommendation.

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