<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04472195</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-P00034169</org_study_id>
    <nct_id>NCT04472195</nct_id>
  </id_info>
  <brief_title>Just-In-Time Rapid Cycle Deliberate Practice Simulation Intubation Training Among Novice Pediatric Anesthesia Trainees: A Randomized Control Study</brief_title>
  <official_title>Just-In-Time Rapid Cycle Deliberate Practice Simulation Intubation Training Among Novice Pediatric Anesthesia Trainees: A Randomized Control Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Children's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the impact of Just-In-Time (J-I-T) Rapid Cycle&#xD;
      Deliberate Practice (RCDP) Simulation Training on laryngoscopy competency among novice&#xD;
      pediatric anesthesia trainees.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Multiple intubation attempts in infants are potentially more harmful than previously&#xD;
      suspected. Emerging literature suggests each additional attempt past an initial laryngoscopy&#xD;
      correlates with a two-fold increase in complications. Therefore, striving to secure the&#xD;
      neonate/infant airway on the first attempt is optimal for infant safety. Novice trainees lack&#xD;
      experience with airway management in small children. To promote a patient safety culture&#xD;
      among the multitude of rotating trainees at Boston Children's Hospital the investigators&#xD;
      would like to augment airway management with Rapid Cycle Deliberate Practice Simulation&#xD;
      Training (RCDP). Rotating trainees at BCH main campus will be prospectively randomized to&#xD;
      experimental vs. control group for intubation of neonates and infants less than or equal to&#xD;
      12 months of age. Infants with known congenital heart disease, known or suspected difficult&#xD;
      airways, or COVID-19 positive status will be excluded from the study. The experimental group&#xD;
      will review a pre-induction airway management plan for their upcoming case and rapid cycle&#xD;
      deliberate practice (RCDP) on a simulator with an anesthesia attending coaching on technique&#xD;
      prior to real patient intubation. Primary outcome measure will be first attempt success rate.&#xD;
      Other outcome measures include: complication rates, a team developed Likert scale that&#xD;
      investigates intubation competency and utility of JIT/RCDP training, and NASA-TLX (a&#xD;
      validated cognitive task load index).&#xD;
&#xD;
      The study would be the first to directly determine how and if simulation-based pediatric&#xD;
      airway interventions are immediately transferable to actual clinical environments in&#xD;
      pediatric anesthesiology. Such a study may change how training programs prepare novices for&#xD;
      &quot;game time&quot; performance and become a new standard of care in airway management training.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Anticipated">September 30, 2023</completion_date>
  <primary_completion_date type="Actual">April 30, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Non-crossover, Prospective Randomized Controlled Trial</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>1st attempt success rate</measure>
    <time_frame>Through study completion, anticipated 12-15 months</time_frame>
    <description>Trainee first attempt success rate will be observed by the study team</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complication rate</measure>
    <time_frame>Through study completion, anticipated 12-15 months</time_frame>
    <description>Trainee complication rates of laryngoscopy will be observed by the study team</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self evaluation of neonate/infant laryngoscopy</measure>
    <time_frame>Through study completion, anticipated 12-15 months</time_frame>
    <description>Trainees will fill out Likert questions developed in conjunction with Boston Children's Survey Methodologist</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of utility of JIT/RCDP</measure>
    <time_frame>Through study completion, anticipated 12-15 months</time_frame>
    <description>Trainees will fill out Likert Questions developed in conjunction with Boston Children's Survey Methodologist</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive Load in intubating patient</measure>
    <time_frame>Through study completion, anticipated 12-15 months</time_frame>
    <description>NASA-TLX will be administered to trainees to evaluate cognitive task load</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">182</enrollment>
  <condition>Anesthesia</condition>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The experimental group will review a pre-induction airway management plan for their upcoming case and undergo a scripted 10-minute RCDP session with an airway coach within 1 hour of patient intubation. The intubation approach (DL vs. video assisted DL) will be chosen by the primary case attending and communicated to the airway coach to simulate the planned laryngoscopy attempt. The experimental group will then proceed with their scheduled case with a member of the research team observing the laryngoscopy attempt(s) to capture data.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The trainees in the control group will have no interventions by the research team, only observation of the intubation and documentation of the same details.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Simulation Airway Coaching</intervention_name>
    <description>Airway coaching on laryngoscopy technique for intubation of neonates/infants within 1 hour of case utilizing RCDP simulation technique.</description>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Anesthesia Residents&#xD;
&#xD;
          -  SRNA&#xD;
&#xD;
          -  Pediatric Anesthesia Fellows&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medical Students&#xD;
&#xD;
          -  Off-Service Rotators&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephen Flynn, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Boston Children's Hopsital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Galvez JA, Acquah S, Ahumada L, Cai L, Polanski M, Wu L, Simpao AF, Tan JM, Wasey J, Fiadjoe JE. Hypoxemia, Bradycardia, and Multiple Laryngoscopy Attempts during Anesthetic Induction in Infants: A Single-center, Retrospective Study. Anesthesiology. 2019 Oct;131(4):830-839. doi: 10.1097/ALN.0000000000002847. Erratum In: Anesthesiology. 2019 Dec;131(6):1373.</citation>
    <PMID>31335549</PMID>
  </reference>
  <reference>
    <citation>Park RS, Rattana-Arpa S, Peyton JM, Huang J, Kordun A, Cravero JP, Zurakowski D, Kovatsis PG. Risk of Hypoxemia by Induction Technique Among Infants and Neonates Undergoing Pyloromyotomy. Anesth Analg. 2021 Feb 1;132(2):367-373. doi: 10.1213/ANE.0000000000004344.</citation>
    <PMID>31361669</PMID>
  </reference>
  <reference>
    <citation>Fiadjoe JE, Nishisaki A, Jagannathan N, Hunyady AI, Greenberg RS, Reynolds PI, Matuszczak ME, Rehman MA, Polaner DM, Szmuk P, Nadkarni VM, McGowan FX Jr, Litman RS, Kovatsis PG. Airway management complications in children with difficult tracheal intubation from the Pediatric Difficult Intubation (PeDI) registry: a prospective cohort analysis. Lancet Respir Med. 2016 Jan;4(1):37-48. doi: 10.1016/S2213-2600(15)00508-1. Epub 2015 Dec 17.</citation>
    <PMID>26705976</PMID>
  </reference>
  <reference>
    <citation>Park R, Peyton JM, Fiadjoe JE, Hunyady AI, Kimball T, Zurakowski D, Kovatsis PG; PeDI Collaborative Investigators; PeDI collaborative investigators. The efficacy of GlideScope(R) videolaryngoscopy compared with direct laryngoscopy in children who are difficult to intubate: an analysis from the paediatric difficult intubation registry. Br J Anaesth. 2017 Nov 1;119(5):984-992. doi: 10.1093/bja/aex344.</citation>
    <PMID>29028952</PMID>
  </reference>
  <reference>
    <citation>Else SDN, Kovatsis PG. A Narrative Review of Oxygenation During Pediatric Intubation and Airway Procedures. Anesth Analg. 2020 Apr;130(4):831-840. doi: 10.1213/ANE.0000000000004403.</citation>
    <PMID>31567323</PMID>
  </reference>
  <reference>
    <citation>Hunt EA, Duval-Arnould JM, Nelson-McMillan KL, Bradshaw JH, Diener-West M, Perretta JS, Shilkofski NA. Pediatric resident resuscitation skills improve after &quot;rapid cycle deliberate practice&quot; training. Resuscitation. 2014 Jul;85(7):945-51. doi: 10.1016/j.resuscitation.2014.02.025. Epub 2014 Mar 4.</citation>
    <PMID>24607871</PMID>
  </reference>
  <reference>
    <citation>Ericsson KA. Acquisition and maintenance of medical expertise: a perspective from the expert-performance approach with deliberate practice. Acad Med. 2015 Nov;90(11):1471-86. doi: 10.1097/ACM.0000000000000939.</citation>
    <PMID>26375267</PMID>
  </reference>
  <reference>
    <citation>Ericsson KA and Pool R. Peak: Secrets From the New Science of Expertise. Boston, Mass. Houghton Mifflin Harcourt; 2016.</citation>
  </reference>
  <reference>
    <citation>Braga MS, Tyler MD, Rhoads JM, Cacchio MP, Auerbach M, Nishisaki A, Larson RJ. Effect of just-in-time simulation training on provider performance and patient outcomes for clinical procedures: a systematic review. BMJ Simul Technol Enhanc Learn. 2015 Oct 5;1(3):94-102. doi: 10.1136/bmjstel-2015-000058. eCollection 2015.</citation>
    <PMID>35515199</PMID>
  </reference>
  <reference>
    <citation>Kessler D, Pusic M, Chang TP, Fein DM, Grossman D, Mehta R, White M, Jang J, Whitfill T, Auerbach M; INSPIRE LP investigators. Impact of Just-in-Time and Just-in-Place Simulation on Intern Success With Infant Lumbar Puncture. Pediatrics. 2015 May;135(5):e1237-46. doi: 10.1542/peds.2014-1911. Epub 2015 Apr 13.</citation>
    <PMID>25869377</PMID>
  </reference>
  <reference>
    <citation>Nishisaki A, Donoghue AJ, Colborn S, Watson C, Meyer A, Brown CA 3rd, Helfaer MA, Walls RM, Nadkarni VM. Effect of just-in-time simulation training on tracheal intubation procedure safety in the pediatric intensive care unit. Anesthesiology. 2010 Jul;113(1):214-23. doi: 10.1097/ALN.0b013e3181e19bf2.</citation>
    <PMID>20526179</PMID>
  </reference>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>July 7, 2023</last_update_submitted>
  <last_update_submitted_qc>July 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston Children's Hospital</investigator_affiliation>
    <investigator_full_name>Stephen Flynn</investigator_full_name>
    <investigator_title>Attending Anesthesiologist</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04472195
org study id: IRB-P00034169
nct id: NCT04472195
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to assess the impact of Just-In-Time (J-I-T) Rapid Cycle
      Deliberate Practice (RCDP) Simulation Training on laryngoscopy competency among novice
      pediatric anesthesia trainees.
Multiple intubation attempts in infants are potentially more harmful than previously
      suspected. Emerging literature suggests each additional attempt past an initial laryngoscopy
      correlates with a two-fold increase in complications. Therefore, striving to secure the
      neonate/infant airway on the first attempt is optimal for infant safety. Novice trainees lack
      experience with airway management in small children. To promote a patient safety culture
      among the multitude of rotating trainees at Boston Children's Hospital the investigators
      would like to augment airway management with Rapid Cycle Deliberate Practice Simulation
      Training (RCDP). Rotating trainees at BCH main campus will be prospectively randomized to
      experimental vs. control group for intubation of neonates and infants less than or equal to
      12 months of age. Infants with known congenital heart disease, known or suspected difficult
      airways, or COVID-19 positive status will be excluded from the study. The experimental group
      will review a pre-induction airway management plan for their upcoming case and rapid cycle
      deliberate practice (RCDP) on a simulator with an anesthesia attending coaching on technique
      prior to real patient intubation. Primary outcome measure will be first attempt success rate.
      Other outcome measures include: complication rates, a team developed Likert scale that
      investigates intubation competency and utility of JIT/RCDP training, and NASA-TLX (a
      validated cognitive task load index).

      The study would be the first to directly determine how and if simulation-based pediatric
      airway interventions are immediately transferable to actual clinical environments in
      pediatric anesthesiology. Such a study may change how training programs prepare novices for
      "game time" performance and become a new standard of care in airway management training.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Non-crossover, Prospective Randomized Controlled Trial
primary purpose: Other
masking: None (Open Label)
measure: 1st attempt success rate
time frame: Through study completion, anticipated 12-15 months
description: Trainee first attempt success rate will be observed by the study team
measure: Complication rate
time frame: Through study completion, anticipated 12-15 months
description: Trainee complication rates of laryngoscopy will be observed by the study team
measure: Self evaluation of neonate/infant laryngoscopy
time frame: Through study completion, anticipated 12-15 months
description: Trainees will fill out Likert questions developed in conjunction with Boston Children's Survey Methodologist
measure: Evaluation of utility of JIT/RCDP
time frame: Through study completion, anticipated 12-15 months
description: Trainees will fill out Likert Questions developed in conjunction with Boston Children's Survey Methodologist
measure: Cognitive Load in intubating patient
time frame: Through study completion, anticipated 12-15 months
description: NASA-TLX will be administered to trainees to evaluate cognitive task load
arm group label: Experimental
arm group type: Experimental
description: The experimental group will review a pre-induction airway management plan for their upcoming case and undergo a scripted 10-minute RCDP session with an airway coach within 1 hour of patient intubation. The intubation approach (DL vs. video assisted DL) will be chosen by the primary case attending and communicated to the airway coach to simulate the planned laryngoscopy attempt. The experimental group will then proceed with their scheduled case with a member of the research team observing the laryngoscopy attempt(s) to capture data.
arm group label: Control
arm group type: No Intervention
description: The trainees in the control group will have no interventions by the research team, only observation of the intubation and documentation of the same details.
intervention type: Other
intervention name: Simulation Airway Coaching
description: Airway coaching on laryngoscopy technique for intubation of neonates/infants within 1 hour of case utilizing RCDP simulation technique.
arm group label: Experimental
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Stephen Flynn, MD
role: Principal Investigator
affiliation: Boston Children's Hospital
facility: 
country: United States
citation: Galvez JA, Acquah S, Ahumada L, Cai L, Polanski M, Wu L, Simpao AF, Tan JM, Wasey J, Fiadjoe JE. Hypoxemia, Bradycardia, and Multiple Laryngoscopy Attempts during Anesthetic Induction in Infants: A Single-center, Retrospective Study. Anesthesiology. 2019 Oct;131(4):830-839. doi: 10.1097/ALN.0000000000002847. Erratum In: Anesthesiology. 2019 Dec;131(6):1373.
PMID: 31335549
citation: Park RS, Rattana-Arpa S, Peyton JM, Huang J, Kordun A, Cravero JP, Zurakowski D, Kovatsis PG. Risk of Hypoxemia by Induction Technique Among Infants and Neonates Undergoing Pyloromyotomy. Anesth Analg. 2021 Feb 1;132(2):367-373. doi: 10.1213/ANE.0000000000004344.
PMID: 31361669
citation: Fiadjoe JE, Nishisaki A, Jagannathan N, Hunyady AI, Greenberg RS, Reynolds PI, Matuszczak ME, Rehman MA, Polaner DM, Szmuk P, Nadkarni VM, McGowan FX Jr, Litman RS, Kovatsis PG. Airway management complications in children with difficult tracheal intubation from the Pediatric Difficult Intubation (PeDI) registry: a prospective cohort analysis. Lancet Respir Med. 2016 Jan;4(1):37-48. doi: 10.1016/S2213-2600(15)00508-1. Epub 2015 Dec 17.
PMID: 26705976
citation: Park R, Peyton JM, Fiadjoe JE, Hunyady AI, Kimball T, Zurakowski D, Kovatsis PG; PeDI Collaborative Investigators; PeDI collaborative investigators. The efficacy of GlideScope(R) videolaryngoscopy compared with direct laryngoscopy in children who are difficult to intubate: an analysis from the paediatric difficult intubation registry. Br J Anaesth. 2017 Nov 1;119(5):984-992. doi: 10.1093/bja/aex344.
PMID: 29028952
citation: Else SDN, Kovatsis PG. A Narrative Review of Oxygenation During Pediatric Intubation and Airway Procedures. Anesth Analg. 2020 Apr;130(4):831-840. doi: 10.1213/ANE.0000000000004403.
PMID: 31567323
citation: Hunt EA, Duval-Arnould JM, Nelson-McMillan KL, Bradshaw JH, Diener-West M, Perretta JS, Shilkofski NA. Pediatric resident resuscitation skills improve after "rapid cycle deliberate practice" training. Resuscitation. 2014 Jul;85(7):945-51. doi: 10.1016/j.resuscitation.2014.02.025. Epub 2014 Mar 4.
PMID: 24607871
citation: Ericsson KA. Acquisition and maintenance of medical expertise: a perspective from the expert-performance approach with deliberate practice. Acad Med. 2015 Nov;90(11):1471-86. doi: 10.1097/ACM.0000000000000939.
PMID: 26375267
citation: Ericsson KA and Pool R. Peak: Secrets From the New Science of Expertise. Boston, Mass. Houghton Mifflin Harcourt; 2016.
citation: Braga MS, Tyler MD, Rhoads JM, Cacchio MP, Auerbach M, Nishisaki A, Larson RJ. Effect of just-in-time simulation training on provider performance and patient outcomes for clinical procedures: a systematic review. BMJ Simul Technol Enhanc Learn. 2015 Oct 5;1(3):94-102. doi: 10.1136/bmjstel-2015-000058. eCollection 2015.
PMID: 35515199
citation: Kessler D, Pusic M, Chang TP, Fein DM, Grossman D, Mehta R, White M, Jang J, Whitfill T, Auerbach M; INSPIRE LP investigators. Impact of Just-in-Time and Just-in-Place Simulation on Intern Success With Infant Lumbar Puncture. Pediatrics. 2015 May;135(5):e1237-46. doi: 10.1542/peds.2014-1911. Epub 2015 Apr 13.
PMID: 25869377
citation: Nishisaki A, Donoghue AJ, Colborn S, Watson C, Meyer A, Brown CA 3rd, Helfaer MA, Walls RM, Nadkarni VM. Effect of just-in-time simulation training on tracheal intubation procedure safety in the pediatric intensive care unit. Anesthesiology. 2010 Jul;113(1):214-23. doi: 10.1097/ALN.0b013e3181e19bf2.
PMID: 20526179
responsible party type: Principal Investigator
investigator affiliation: Boston Children's Hospital
investigator full name: Stephen Flynn
investigator title: Attending Anesthesiologist
sharing ipd: No