<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/NCT04477044</url>
  </required_header>
  <id_info>
    <org_study_id>NUS IRB B-15-274</org_study_id>
    <nct_id>NCT04477044</nct_id>
  </id_info>
  <brief_title>Use of Point-of-View Camera to Faciliate Learning of Endotracheal Intubation</brief_title>
  <official_title>Use of Point-of-View Camera to Faciliate Learning of Endotracheal Intubation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National University of Singapore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National University of Singapore</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 study team proposes that mounting a point-of-view camera on the student's head will&#xD;
      enable the team to view what the student is seeing in real-time when intubating with a normal&#xD;
      laryngoscope. This will allow the team to guide the students accurately. When used in&#xD;
      conjunction with the established simulation programme in the department, it is believed that&#xD;
      this will improve the learning and retention of this skill when compared to standard&#xD;
      teaching.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The ability to correctly perform an endotracheal intubation is a life-saving skill that every&#xD;
      doctor should possess. It is an integral part of established protocols for resuscitation and&#xD;
      advanced cardiac life support (ACLS). It is an essential procedural skill that is taught to&#xD;
      all students at the Yong Loo Lin School of Medicine, NUS. It is also recommended by the&#xD;
      American Association of Medical Colleges as an essential procedural skill for medical&#xD;
      students to learn.&#xD;
&#xD;
      Timely and correctly performed endotracheal intubation can be life-saving because it&#xD;
      maintains and protects the airway, reliably provides adequate tidal volumes, frees the hands&#xD;
      of rescuers, allows the removal of airway secretions and provides a route for giving drugs.&#xD;
      However, poorly performed endotracheal intubation exposes patients to the life-threatening&#xD;
      risks associated with the unrecognised misplacement of a tracheal tube and leads to delays in&#xD;
      resuscitative efforts.&#xD;
&#xD;
      Unfortunately, there is a comparatively high failure rate associated with endotracheal&#xD;
      intubation because this skill is difficult to learn and retain. Mulcaster et al reported&#xD;
      that, to achieve a 90% intubation success rate, a mean of 47 intubation attempts were&#xD;
      required. In a similar study, Konrad et al found that a mean of 57 attempts were required to&#xD;
      achieve a 90% intubation success rate. This difficulty in learning is compounded by the&#xD;
      finding that, without repeated practice, the ability to perform endotracheal intubation&#xD;
      successfully diminishes rapidly. The intubation success rate of infrequent users who have&#xD;
      successfully learned to intubate has been shown to fall to as little as 57% after only 6&#xD;
      months. Clearly, there is a need to improve the learning and retention of endotracheal&#xD;
      intubation.&#xD;
&#xD;
      The PI previously published a randomized controlled trial in the journal Medical Education to&#xD;
      study the utility of experiential learning on a simulator in the learning and retention of&#xD;
      this skill. It was showed that with experiential learning, more students were able to&#xD;
      intubate a manikin at 3 months (64.5% vs. 36.9%, p&lt;0.001). With repeated learning (refresher&#xD;
      every 3 months), 86% of students were able to successfully perform endotracheal intubation at&#xD;
      12 months.&#xD;
&#xD;
      However, there are limitations to acquiring this skill on a simulator, as it has been argued&#xD;
      that expertise gained on manikins may not translate into successful intubations in patients.&#xD;
      Learning on actual patients is desirable, but impractical given the large number of students&#xD;
      in our medical school. On average, each YLLSoM student only intubates between 3-5 patients,&#xD;
      far less than the 47-57 endotracheal intubations necessary to gain expertise as cited&#xD;
      earlier. Combining the learning experiences on the simulator with that on actual patients&#xD;
      appears to be the best solution.&#xD;
&#xD;
      Therefore it is important to optimize the limited learning opportunities on patients.&#xD;
      However, this is often difficult because the mouth is small, and the view of the pharyngeal&#xD;
      structures is limited. The tutor will not be able to view what the student is seeing as there&#xD;
      is only one line of vision. More recently, video-laryngoscopes, which are laryngoscopes with&#xD;
      a camera at its tip, have emerged as an effective means of teaching endotracheal intubation.&#xD;
      However, the technique of using the video-laryngoscope differs from using the common&#xD;
      laryngoscope due to its different shape and the requirement that the student looks at the&#xD;
      screen rather than into the patient's mouth. Hence it is unclear if the ability to&#xD;
      successfully perform endotracheal intubation with a video-laryngoscope necessarily translates&#xD;
      into the ability to perform endotracheal intubation with a normal laryngoscope.&#xD;
&#xD;
      The study team proposes that mounting a point-of-view camera on the student's head will&#xD;
      enable the team to view what the student is seeing in real-time when intubating with a normal&#xD;
      laryngoscope. This will allow the team to guide the students accurately. When used in&#xD;
      conjunction with the established simulation programme in the department, it is believed that&#xD;
      this will improve the learning and retention of this skill when compared to standard&#xD;
      teaching.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      Students will be randomised into 2 groups. For the study group, students will have a GoPro&#xD;
      Hero4 camera mounted on their head which will be linked via Wi-Fi to allow real-time&#xD;
      streaming of the view onto a laptop, while students in control group will have a regular type&#xD;
      of tutorial and practicing session. Data such as time to successful intubation and Cormack&#xD;
      Lehane laryngoscopy view will be recorded. At the end of the session, tutors will use a&#xD;
      debrief guide to give feedback to students. Students from the study group will be given a&#xD;
      questionnaire to be completed at the end of the session.&#xD;
&#xD;
      These students will be recalled 3 months later. Each student will individually be assessed on&#xD;
      his or her intubation skill using 2 different manikin: a normal airway manikin and a&#xD;
      difficult airway manikin. All the students will be wearing the GoPro Hero4 this time round.&#xD;
      Data such as time to successful intubation and Cormack Lehane laryngoscopy view will be&#xD;
      recorded. Students will be given feedback as appropriate by tutors for their learning&#xD;
      purposes using the same debrief guide. There will be questionnaires for both students and&#xD;
      tutors to fill in this time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 12, 2016</start_date>
  <completion_date type="Actual">October 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</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>The participants will be randomised to 2 groups, either in the study group having a GoPro Hero4 camera mounted on their head or control group with no GoPro Hero4 camera mounted on their head</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intubation Timing between GoPro and non-GoPro group at first intubation session</measure>
    <time_frame>During procedure of first intubation session</time_frame>
    <description>To record the difference in time taken for successful intubation of the manikin between the GoPro and non-GoPro group</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intubation Timing between GoPro and non-GoPro group at 3 months follow-up session</measure>
    <time_frame>During procedure of 3-month follow-up session</time_frame>
    <description>To record the difference in time taken for successful intubation of the manikin between the GoPro and non-GoPro group</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Usefulness of GoPro in learning</measure>
    <time_frame>Immediately after first intubation tryout session and follow-up session 3 months later</time_frame>
    <description>To find out the usefulness of GoPro in learning using a questionnaire comprising of yes/no questions</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">71</enrollment>
  <condition>Intubation; Difficult or Failed</condition>
  <condition>Anesthesia</condition>
  <arm_group>
    <arm_group_label>No GoPro</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No GoPro Hero4 to be mounted on the participant's head while he/she performs intubation on a manikin.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GoPro</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GoPro Hero4 to be mounted on the participant's head while he/she performs intubation on a manikin.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Study Group</intervention_name>
    <description>GoPro Hero4 to be mounted on the participant's forehead while performing intubation on a manikin.</description>
    <arm_group_label>GoPro</arm_group_label>
    <other_name>GoPro</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All medical students rotating through a 2-week posting in Anaesthesia at NUHS during&#xD;
             Year 4 of medical school&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  NIL&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lian Kah Ti</last_name>
    <role>Principal Investigator</role>
    <affiliation>National University of Singapore</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National University Health System</name>
      <address>
        <city>Singapore</city>
        <zip>119074</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <reference>
    <citation>Mulcaster JT, Mills J, Hung OR, MacQuarrie K, Law JA, Pytka S, Imrie D, Field C. Laryngoscopic intubation: learning and performance. Anesthesiology. 2003 Jan;98(1):23-7. doi: 10.1097/00000542-200301000-00007.</citation>
    <PMID>12502974</PMID>
  </reference>
  <reference>
    <citation>Konrad C, Schupfer G, Wietlisbach M, Gerber H. Learning manual skills in anesthesiology: Is there a recommended number of cases for anesthetic procedures? Anesth Analg. 1998 Mar;86(3):635-9. doi: 10.1097/00000539-199803000-00037.</citation>
    <PMID>9495429</PMID>
  </reference>
  <reference>
    <citation>Ti LK, Chen FG, Tan GM, Tan WT, Tan JM, Shen L, Goy RW. Experiential learning improves the learning and retention of endotracheal intubation. Med Educ. 2009 Jul;43(7):654-60. doi: 10.1111/j.1365-2923.2009.03399.x.</citation>
    <PMID>19573188</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>July 15, 2020</last_update_submitted>
  <last_update_submitted_qc>July 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National University of Singapore</investigator_affiliation>
    <investigator_full_name>NUS Anaesthesia</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Medical Education</keyword>
  <keyword>Intubation</keyword>
  <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/NCT04477044
org study id: NUS IRB B-15-274
nct id: NCT04477044
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study team proposes that mounting a point-of-view camera on the student's head will
      enable the team to view what the student is seeing in real-time when intubating with a normal
      laryngoscope. This will allow the team to guide the students accurately. When used in
      conjunction with the established simulation programme in the department, it is believed that
      this will improve the learning and retention of this skill when compared to standard
      teaching.
The ability to correctly perform an endotracheal intubation is a life-saving skill that every
      doctor should possess. It is an integral part of established protocols for resuscitation and
      advanced cardiac life support (ACLS). It is an essential procedural skill that is taught to
      all students at the Yong Loo Lin School of Medicine, NUS. It is also recommended by the
      American Association of Medical Colleges as an essential procedural skill for medical
      students to learn.

      Timely and correctly performed endotracheal intubation can be life-saving because it
      maintains and protects the airway, reliably provides adequate tidal volumes, frees the hands
      of rescuers, allows the removal of airway secretions and provides a route for giving drugs.
      However, poorly performed endotracheal intubation exposes patients to the life-threatening
      risks associated with the unrecognised misplacement of a tracheal tube and leads to delays in
      resuscitative efforts.

      Unfortunately, there is a comparatively high failure rate associated with endotracheal
      intubation because this skill is difficult to learn and retain. Mulcaster et al reported
      that, to achieve a 90% intubation success rate, a mean of 47 intubation attempts were
      required. In a similar study, Konrad et al found that a mean of 57 attempts were required to
      achieve a 90% intubation success rate. This difficulty in learning is compounded by the
      finding that, without repeated practice, the ability to perform endotracheal intubation
      successfully diminishes rapidly. The intubation success rate of infrequent users who have
      successfully learned to intubate has been shown to fall to as little as 57% after only 6
      months. Clearly, there is a need to improve the learning and retention of endotracheal
      intubation.

      The PI previously published a randomized controlled trial in the journal Medical Education to
      study the utility of experiential learning on a simulator in the learning and retention of
      this skill. It was showed that with experiential learning, more students were able to
      intubate a manikin at 3 months (64.5% vs. 36.9%, p<0.001). With repeated learning (refresher
      every 3 months), 86% of students were able to successfully perform endotracheal intubation at
      12 months.

      However, there are limitations to acquiring this skill on a simulator, as it has been argued
      that expertise gained on manikins may not translate into successful intubations in patients.
      Learning on actual patients is desirable, but impractical given the large number of students
      in our medical school. On average, each YLLSoM student only intubates between 3-5 patients,
      far less than the 47-57 endotracheal intubations necessary to gain expertise as cited
      earlier. Combining the learning experiences on the simulator with that on actual patients
      appears to be the best solution.

      Therefore it is important to optimize the limited learning opportunities on patients.
      However, this is often difficult because the mouth is small, and the view of the pharyngeal
      structures is limited. The tutor will not be able to view what the student is seeing as there
      is only one line of vision. More recently, video-laryngoscopes, which are laryngoscopes with
      a camera at its tip, have emerged as an effective means of teaching endotracheal intubation.
      However, the technique of using the video-laryngoscope differs from using the common
      laryngoscope due to its different shape and the requirement that the student looks at the
      screen rather than into the patient's mouth. Hence it is unclear if the ability to
      successfully perform endotracheal intubation with a video-laryngoscope necessarily translates
      into the ability to perform endotracheal intubation with a normal laryngoscope.

      The study team proposes that mounting a point-of-view camera on the student's head will
      enable the team to view what the student is seeing in real-time when intubating with a normal
      laryngoscope. This will allow the team to guide the students accurately. When used in
      conjunction with the established simulation programme in the department, it is believed that
      this will improve the learning and retention of this skill when compared to standard
      teaching.

      Methods:

      Students will be randomised into 2 groups. For the study group, students will have a GoPro
      Hero4 camera mounted on their head which will be linked via Wi-Fi to allow real-time
      streaming of the view onto a laptop, while students in control group will have a regular type
      of tutorial and practicing session. Data such as time to successful intubation and Cormack
      Lehane laryngoscopy view will be recorded. At the end of the session, tutors will use a
      debrief guide to give feedback to students. Students from the study group will be given a
      questionnaire to be completed at the end of the session.

      These students will be recalled 3 months later. Each student will individually be assessed on
      his or her intubation skill using 2 different manikin: a normal airway manikin and a
      difficult airway manikin. All the students will be wearing the GoPro Hero4 this time round.
      Data such as time to successful intubation and Cormack Lehane laryngoscopy view will be
      recorded. Students will be given feedback as appropriate by tutors for their learning
      purposes using the same debrief guide. There will be questionnaires for both students and
      tutors to fill in this time.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The participants will be randomised to 2 groups, either in the study group having a GoPro Hero4 camera mounted on their head or control group with no GoPro Hero4 camera mounted on their head
primary purpose: Other
masking: None (Open Label)
measure: Intubation Timing between GoPro and non-GoPro group at first intubation session
time frame: During procedure of first intubation session
description: To record the difference in time taken for successful intubation of the manikin between the GoPro and non-GoPro group
measure: Intubation Timing between GoPro and non-GoPro group at 3 months follow-up session
time frame: During procedure of 3-month follow-up session
description: To record the difference in time taken for successful intubation of the manikin between the GoPro and non-GoPro group
measure: Usefulness of GoPro in learning
time frame: Immediately after first intubation tryout session and follow-up session 3 months later
description: To find out the usefulness of GoPro in learning using a questionnaire comprising of yes/no questions
arm group label: No GoPro
arm group type: No Intervention
description: No GoPro Hero4 to be mounted on the participant's head while he/she performs intubation on a manikin.
arm group label: GoPro
arm group type: Experimental
description: GoPro Hero4 to be mounted on the participant's head while he/she performs intubation on a manikin.
intervention type: Other
intervention name: Study Group
description: GoPro Hero4 to be mounted on the participant's forehead while performing intubation on a manikin.
arm group label: GoPro
other name: GoPro
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Lian Kah Ti
role: Principal Investigator
affiliation: National University of Singapore
facility: 
country: Singapore
citation: Mulcaster JT, Mills J, Hung OR, MacQuarrie K, Law JA, Pytka S, Imrie D, Field C. Laryngoscopic intubation: learning and performance. Anesthesiology. 2003 Jan;98(1):23-7. doi: 10.1097/00000542-200301000-00007.
PMID: 12502974
citation: Konrad C, Schupfer G, Wietlisbach M, Gerber H. Learning manual skills in anesthesiology: Is there a recommended number of cases for anesthetic procedures? Anesth Analg. 1998 Mar;86(3):635-9. doi: 10.1097/00000539-199803000-00037.
PMID: 9495429
citation: Ti LK, Chen FG, Tan GM, Tan WT, Tan JM, Shen L, Goy RW. Experiential learning improves the learning and retention of endotracheal intubation. Med Educ. 2009 Jul;43(7):654-60. doi: 10.1111/j.1365-2923.2009.03399.x.
PMID: 19573188
responsible party type: Principal Investigator
investigator affiliation: National University of Singapore
investigator full name: NUS Anaesthesia
investigator title: Principal Investigator
sharing ipd: No