NCT04279860

Brief Summary

Background: Foreign body airway obstruction (FBAO) is often described as an uncommon cause of Out of Hospital Cardiac Arrest (OHCA) accounting for approximately 1.4% of all OHCA. Reported incidents rates of FBAO causing cardiac arrest are unclear, and first aid by layperson are not well described. The aim of the epidemiological part of the study is:

  • to investigate information on actions taken by EMS-personnel and laypersons
  • to investigate outcomes of hypoxic Cardiac Arrest due to foreign body airway obstruction in Denmark
  • to increase overall survival. propose new guidelines and strategies to increase survival from OHCA caused by FBAO. The aim of advanced text-string search algorithm part of the study is \- To investigate if an advanced text-string search algorithm can identify FBAO in medical records with high sensitivity Methods: National data will be collected from the verified 2016-2019 Danish OHCA register, and cases with FBAO prior to OHCA will selected via a direct marking by external validation and advanced text search. Patients reported as indisputably deceased (late signs of death) was excluded. Incidence rates per 100.000 citizens, survival rates to hospital and first aid actions by layperson are presented. A pilot study have been conducted in regional data from 2016-2019 and the study group have concluded that, a national study is feasible with the current amount of data and the used methodology. Expected outcome: This study will enable targeted campaigns aimed at increasing survival from OHCA caused by FBAO. Potential campaigns might target the food items provided to potential vulnerable groups and guide focus for first aid recommendations. Further, with a deeper understanding of which airway management procedures most often are successful, it will be possible to improve EMS treatments of vulnerable groups. Finally, a novel method of extracting information from the electronic medical records will be developed creating the foundation for future works on other prehospital conditions

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2019

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 17, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 21, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

February 21, 2020

Status Verified

February 1, 2020

Enrollment Period

2 years

First QC Date

February 17, 2020

Last Update Submit

February 20, 2020

Conditions

Outcome Measures

Primary Outcomes (4)

  • Return-of-spontaneous-circulation (ROSC)

    ROSC will be defined as cases achieving ROSC anytime between recognition of the event and termination (defined as either hospital admission og declaration of death by EMS-personnel).

    through study completion, an average of 1 year

  • 30-day Survival

    Survival will be defined as ROSC at the time of hospital admission. Further the investigators will include rates for 30-day survival derived with data from the National Patient Registry.

    through study completion, an average of 1 year

  • State at hospital admission

    Defined as the case state on arrival at the hospital as either; ROSC or ongoing CPR.

    through study completion, an average of 1 year

  • Incidence rate

    Incidence rate of out-of-hospital cardiac arrest caused by foreign body airway obstruction per 100.000 citizens

    through study completion, an average of 1 year

Other Outcomes (1)

  • Treatment initiated by laypersons

    through study completion, an average of 1 year

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Data will collected from the verified 2016-2019 Danish out-of-hospital cardiac arrest (OHCA) register, and cases with foreign body airway obstruction prior to OHCA will selected via a direct marking by external validation and advanced text search.

You may qualify if:

  • All persons suffering from out-of-hospital cardiac arrest (OHCA) in Denmark from 2016-2020 identified in the verified danish OHCA register.

You may not qualify if:

  • Patients reported as indisputably deceased (late signs of death) will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Copenhagen Emergency Medical Services

Copenhagen, 2750, Denmark

Location

Related Publications (16)

  • Kinoshita K, Azuhata T, Kawano D, Kawahara Y. Relationships between pre-hospital characteristics and outcome in victims of foreign body airway obstruction during meals. Resuscitation. 2015 Mar;88:63-7. doi: 10.1016/j.resuscitation.2014.12.018. Epub 2014 Dec 31.

    PMID: 25555359BACKGROUND
  • Wong SC, Tariq SM. Cardiac arrest following foreign-body aspiration. Respir Care. 2011 Apr;56(4):527-9. doi: 10.4187/respcare.00766. Epub 2011 Jan 21. No abstract available.

    PMID: 21255495BACKGROUND
  • Number of choking deaths by place of occurrence and age, registered in England and Wales, 2014 to 2016: [Internet/in Danish]. [cited 2019 Nov 06]; Available from:https://www.ons.gov.uk/peoplepopulationandcommunity/birthsdeathsandmarriages/deaths/adhocs/007747numberofchokingdeathsbyplaceofoccurrenceandageregisteredinenglandandwales2014to2016

    BACKGROUND
  • Sakai T, Kitamura T, Iwami T, Nishiyama C, Tanigawa-Sugihara K, Hayashida S, Nishiuchi T, Kajino K, Irisawa T, Shiozaki T, Ogura H, Tasaki O, Kuwagata Y, Hiraide A, Shimazu T. Effectiveness of prehospital Magill forceps use for out-of-hospital cardiac arrest due to foreign body airway obstruction in Osaka City. Scand J Trauma Resusc Emerg Med. 2014 Sep 4;22:53. doi: 10.1186/s13049-014-0053-3.

    PMID: 25182381BACKGROUND
  • Lindskou TA, Mikkelsen S, Christensen EF, Hansen PA, Jorgensen G, Hendriksen OM, Kirkegaard H, Berlac PA, Sovso MB. The Danish prehospital emergency healthcare system and research possibilities. Scand J Trauma Resusc Emerg Med. 2019 Nov 4;27(1):100. doi: 10.1186/s13049-019-0676-5.

    PMID: 31684982BACKGROUND
  • Committee on Injury, Violence, and Poison Prevention. Prevention of choking among children. Pediatrics. 2010 Mar;125(3):601-7. doi: 10.1542/peds.2009-2862. Epub 2010 Feb 22.

    PMID: 20176668BACKGROUND
  • Duckett SA, Roten RA. Choking. [Updated 2019 Apr 9]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2019 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK499941/

    BACKGROUND
  • Rimell FL, Thome A Jr, Stool S, Reilly JS, Rider G, Stool D, Wilson CL. Characteristics of objects that cause choking in children. JAMA. 1995 Dec 13;274(22):1763-6.

    PMID: 7500505BACKGROUND
  • Kramarow E, Warner M, Chen LH. Food-related choking deaths among the elderly. Inj Prev. 2014 Jun;20(3):200-3. doi: 10.1136/injuryprev-2013-040795. Epub 2013 Sep 3.

    PMID: 24003082BACKGROUND
  • Wu WS, Sung KC, Cheng TJ, Lu TH. Associations between chronic diseases and choking deaths among older adults in the USA: a cross-sectional study using multiple cause mortality data from 2009 to 2013. BMJ Open. 2015 Nov 12;5(11):e009464. doi: 10.1136/bmjopen-2015-009464.

    PMID: 26563213BACKGROUND
  • Igarashi Y, Norii T, Sung-Ho K, Nagata S, Tagami T, Femling J, Mizushima Y, Yokota H. New classifications for Life-threatening foreign body airway obstruction. Am J Emerg Med. 2019 Dec;37(12):2177-2181. doi: 10.1016/j.ajem.2019.03.015. Epub 2019 Mar 9.

    PMID: 30880041BACKGROUND
  • Igarashi Y, Yokobori S, Yoshino Y, Masuno T, Miyauchi M, Yokota H. Prehospital removal improves neurological outcomes in elderly patient with foreign body airway obstruction. Am J Emerg Med. 2017 Oct;35(10):1396-1399. doi: 10.1016/j.ajem.2017.04.016. Epub 2017 Apr 10.

    PMID: 28427784BACKGROUND
  • Perkins GD, Handley AJ, Koster RW, Castren M, Smyth MA, Olasveengen T, Monsieurs KG, Raffay V, Grasner JT, Wenzel V, Ristagno G, Soar J; Adult basic life support and automated external defibrillation section Collaborators. European Resuscitation Council Guidelines for Resuscitation 2015: Section 2. Adult basic life support and automated external defibrillation. Resuscitation. 2015 Oct;95:81-99. doi: 10.1016/j.resuscitation.2015.07.015. Epub 2015 Oct 15. No abstract available.

    PMID: 26477420BACKGROUND
  • Heimlich HJ, Patrick EA. The Heimlich maneuver. Best technique for saving any choking victim's life. Postgrad Med. 1990 May 1;87(6):38-48, 53. doi: 10.1080/00325481.1990.11716329.

    PMID: 2186401BACKGROUND
  • Dansk Hjertestopsregister [Internet/in Danish]. [cited 2019 Nov 06]; Available from: http://hjertestopregister.dk/wp-content/uploads/2019/11/Dansk-Hjertestopregister-2018.pdf

    BACKGROUND
  • Wissenberg M, Lippert FK, Folke F, Weeke P, Hansen CM, Christensen EF, Jans H, Hansen PA, Lang-Jensen T, Olesen JB, Lindhardsen J, Fosbol EL, Nielsen SL, Gislason GH, Kober L, Torp-Pedersen C. Association of national initiatives to improve cardiac arrest management with rates of bystander intervention and patient survival after out-of-hospital cardiac arrest. JAMA. 2013 Oct 2;310(13):1377-84. doi: 10.1001/jama.2013.278483.

    PMID: 24084923BACKGROUND

MeSH Terms

Conditions

Out-of-Hospital Cardiac ArrestRespiratory AspirationHeart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesRespiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Freddy K Lippert, MD, Ass. Professor

    Copenhagen Emergency Medical Services

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Target Duration
30 Days
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2020

First Posted

February 21, 2020

Study Start

February 1, 2019

Primary Completion

February 1, 2021

Study Completion

February 1, 2022

Last Updated

February 21, 2020

Record last verified: 2020-02

Locations