<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/NCT03234283</url>
  </required_header>
  <id_info>
    <org_study_id>2016-01657</org_study_id>
    <nct_id>NCT03234283</nct_id>
  </id_info>
  <brief_title>Visualization of the Intubation Pathway With the &quot;IRRIS&quot;-Device</brief_title>
  <acronym>IRRIS</acronym>
  <official_title>Video-laryngoscopic Visualization of the Intubation Pathway With the &quot;IRRIS&quot;-Device. A Clinical Safety and Proof of Concept Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Zurich</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>
      A prospective, open label, non-randomized, single centre safety and feasibility study.&#xD;
      Patients with no expected airway difficulties scheduled for elective surgery including&#xD;
      tracheal intubation and general anesthesia procedures will be enrolled into the study.&#xD;
      Following standard induction of anesthesia, the IRRIS will be attached to the patient's neck&#xD;
      skin just beneath the laryngeal prominence (Adam's apple) and the intubation will be&#xD;
      performed by using a video-laryngoscope in a standardized fashion. The IRRIS device emits a&#xD;
      light that penetrates through the skin into the airway and that is visible on the&#xD;
      video-laryngoscope display. This light highlights the right pathway for the tracheal tube and&#xD;
      facilitates the visual recognition and identification of the laryngeal inlet. In case of&#xD;
      problems identified during the induction period such as an unexpected difficult intubation&#xD;
      situation and the IRRIS does not provide the expected facilitation of intubation, the local&#xD;
      &quot;unexpected difficult airway&quot; protocol goes into effect.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The IRRIS (InfraRed - Red Intubation System) is an external disposable light source in a&#xD;
      patch that is intended for single use while it is placed externally on the patient's neck&#xD;
      before tracheal intubation for the duration of tracheal intubation. The device transmits&#xD;
      near-infrared light through the skin towards the trachea. During laryngoscopy, the emitted&#xD;
      light becomes visible only from the trachea and not from the oesophagus. Video assisted&#xD;
      devices which already are in the market known as video-laryngoscopes and fiberoptic&#xD;
      bronchoscopes are capable of detecting and visualizing the emitted light so that the&#xD;
      anaesthesiologist who is performing the intubation is aided to direct and insert the&#xD;
      endotracheal tube into the trachea by following the light on the screen of his video-assisted&#xD;
      endoscope. The objective of this study is to assess the safety, and performance of IRRIS in&#xD;
      patients who undergo tracheal intubation in terms of skin integrity, duration of intubation,&#xD;
      number of attempts, success of intubation and usability aspects in terms of subjective&#xD;
      physician grading of the IRRIS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Actual">November 14, 2017</completion_date>
  <primary_completion_date type="Actual">November 14, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>A prospective, open label, non-randomized, safety and feasibility study.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety 1: Absence of skin lesions</measure>
    <time_frame>15 minutes after end of anesthesia</time_frame>
    <description>skin lesions, irritations after removal of the patch at the end of anesthesia (yes / no)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety 2: Severity of skin lesions</measure>
    <time_frame>15 minutes after end of anesthesia</time_frame>
    <description>skin lesions, irritations after removal of the patch at the end of anesthesia (mild/moderate/severe)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proof of Concept 2: Intubation success</measure>
    <time_frame>5 minutes after start of intubation</time_frame>
    <description>Successful video-laryngoscopic tracheal intubation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proof of Concept 3: Intubation success</measure>
    <time_frame>5 minutes after start of intubation</time_frame>
    <description>Duration of intubation (time in seconds from inserting the video laryngoscope till tracheal tube cuff inflation)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proof of Concept 4: Intubation success</measure>
    <time_frame>5 minutes after start of intubation</time_frame>
    <description>Number of video laryngoscopy attempts till successful tracheal tube placement (number of video laryngoscope insertions during an intubation process that are related to the IRRIS operation)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proof of Concept 5: Ease of use of IRRIS</measure>
    <time_frame>5 minutes after start of intubation</time_frame>
    <description>Subjective degree of difficulty of the entire intubation process according a Verbal Rating Scale (VRS) assessed by the intubation person (values from 1 = very easy to 10 = extremely difficult)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proof of Concept 7: Ease of use of IRRIS</measure>
    <time_frame>5 minutes after start of intubation</time_frame>
    <description>Subjective degree of helpfulness of the visual aid by the device: according a Verbal Rating Scale (VRS) assessed by the intubation person (values from 1 = not helpful at all to 10 = very helpful)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proof of Concept 8: Intubation success</measure>
    <time_frame>5 minutes after start of intubation</time_frame>
    <description>Failures: necessity of alternative airway securing or abort of tracheal intubation if initial attempt(s) with IRRIS failed. (yes / no and number and choice of alternative techniques)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Difficult Intubation</condition>
  <arm_group>
    <arm_group_label>Study intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants will be intubated with a video-laryngiscope by guiding the tracheal tube according to the highlighted Larynx on the Video Screen.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>IRRIS InfraRed - Red Intubation System</intervention_name>
    <description>IRRIS will be attached to the patient's neck skin just beneath the laryngeal prominence. Tracheal intubation will be performed by using a video-laryngoscope in a standardized Fashion and by guiding the tracheal tube into the Larynx by following the visual Signal on the Screen that is caused by IRRIS. The handling of IRRIS and the Performance of tracheal Intubation will be recorded. Patients will be monitored for safety parameters and possible adverse events during the study until recovered and released from the postoperative care unit.</description>
    <arm_group_label>Study intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male and female patients scheduled for elective surgery requiring general anesthesia&#xD;
             and tracheal intubation.&#xD;
&#xD;
          2. Patient age: adult (&gt;18 years old)&#xD;
&#xD;
          3. Mallampati scores 1 to 3.&#xD;
&#xD;
          4. ASA Physical Status Classification System 1-3&#xD;
&#xD;
          5. Ability to understand the requirements of the study, willingness to comply with its&#xD;
             instructions and schedules, and agreement to the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Emergency cases&#xD;
&#xD;
          2. Expected airway difficulties as defined during the pre-anaesthesia visit&#xD;
&#xD;
          3. Necessity for an alternative airway management approach other than by using a&#xD;
             video-laryngoscope&#xD;
&#xD;
          4. Rapid sequence induction&#xD;
&#xD;
          5. Skin disorders and skin light sensitivity (SLE, lupus, Porphyria, Dermatomyositis,&#xD;
             Pemphigus, Pellagra etc.)&#xD;
&#xD;
          6. Known history of any significant medical disorder, which in the investigator's&#xD;
             judgment contraindicates the patient's participation&#xD;
&#xD;
          7. Impaired head and neck mobility&#xD;
&#xD;
          8. Scars or skin injuries at the neck&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter Biro, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Zurich, Institue of Anesthesiology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Zurich, Institue of Anesthesiology</name>
      <address>
        <city>Zurich</city>
        <state>ZH</state>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <results_reference>
    <citation>Goto Y, Goto T, Hagiwara Y, Tsugawa Y, Watase H, Okamoto H, Hasegawa K; Japanese Emergency Medicine Network Investigators. Techniques and outcomes of emergency airway management in Japan: An analysis of two multicentre prospective observational studies, 2010-2016. Resuscitation. 2017 May;114:14-20. doi: 10.1016/j.resuscitation.2017.02.009. Epub 2017 Feb 17.</citation>
    <PMID>28219617</PMID>
  </results_reference>
  <results_reference>
    <citation>Brown CA 3rd, Bair AE, Pallin DJ, Walls RM; NEAR III Investigators. Techniques, success, and adverse events of emergency department adult intubations. Ann Emerg Med. 2015 Apr;65(4):363-370.e1. doi: 10.1016/j.annemergmed.2014.10.036. Epub 2014 Dec 20. Erratum In: Ann Emerg Med. 2017 May;69(5):540.</citation>
    <PMID>25533140</PMID>
  </results_reference>
  <results_reference>
    <citation>Howard-Quijano KJ, Huang YM, Matevosian R, Kaplan MB, Steadman RH. Video-assisted instruction improves the success rate for tracheal intubation by novices. Br J Anaesth. 2008 Oct;101(4):568-72. doi: 10.1093/bja/aen211. Epub 2008 Aug 1.</citation>
    <PMID>18676418</PMID>
  </results_reference>
  <results_reference>
    <citation>Song Y, Oh J, Chee Y, Lim T, Kang H, Cho Y. A novel method to position an endotracheal tube at the correct depth using an infrared sensor stylet. Can J Anaesth. 2013 May;60(5):444-9. doi: 10.1007/s12630-013-9898-6. Epub 2013 Feb 1.</citation>
    <PMID>23370979</PMID>
  </results_reference>
  <results_reference>
    <citation>El-Sayed IH, Ho JE, Eisele DW. External light guidance for percutaneous dilatational tracheotomy. Head Neck. 2011 Aug;33(8):1206-9. doi: 10.1002/hed.21610. Epub 2011 Mar 16.</citation>
    <PMID>21413098</PMID>
  </results_reference>
  <results_reference>
    <citation>Kaplan MB, Ward D, Hagberg CA, Berci G, Hagiike M. Seeing is believing: the importance of video laryngoscopy in teaching and in managing the difficult airway. Surg Endosc. 2006 Apr;20 Suppl 2:S479-83. doi: 10.1007/s00464-006-0038-z. Epub 2006 Mar 16.</citation>
    <PMID>16544062</PMID>
  </results_reference>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>May 18, 2017</study_first_submitted>
  <study_first_submitted_qc>July 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2017</study_first_posted>
  <last_update_submitted>November 14, 2017</last_update_submitted>
  <last_update_submitted_qc>November 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03234283
org study id: 2016-01657
nct id: NCT03234283
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A prospective, open label, non-randomized, single centre safety and feasibility study.
      Patients with no expected airway difficulties scheduled for elective surgery including
      tracheal intubation and general anesthesia procedures will be enrolled into the study.
      Following standard induction of anesthesia, the IRRIS will be attached to the patient's neck
      skin just beneath the laryngeal prominence (Adam's apple) and the intubation will be
      performed by using a video-laryngoscope in a standardized fashion. The IRRIS device emits a
      light that penetrates through the skin into the airway and that is visible on the
      video-laryngoscope display. This light highlights the right pathway for the tracheal tube and
      facilitates the visual recognition and identification of the laryngeal inlet. In case of
      problems identified during the induction period such as an unexpected difficult intubation
      situation and the IRRIS does not provide the expected facilitation of intubation, the local
      "unexpected difficult airway" protocol goes into effect.
The IRRIS (InfraRed - Red Intubation System) is an external disposable light source in a
      patch that is intended for single use while it is placed externally on the patient's neck
      before tracheal intubation for the duration of tracheal intubation. The device transmits
      near-infrared light through the skin towards the trachea. During laryngoscopy, the emitted
      light becomes visible only from the trachea and not from the oesophagus. Video assisted
      devices which already are in the market known as video-laryngoscopes and fiberoptic
      bronchoscopes are capable of detecting and visualizing the emitted light so that the
      anaesthesiologist who is performing the intubation is aided to direct and insert the
      endotracheal tube into the trachea by following the light on the screen of his video-assisted
      endoscope. The objective of this study is to assess the safety, and performance of IRRIS in
      patients who undergo tracheal intubation in terms of skin integrity, duration of intubation,
      number of attempts, success of intubation and usability aspects in terms of subjective
      physician grading of the IRRIS.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: A prospective, open label, non-randomized, safety and feasibility study.
primary purpose: Other
masking: None (Open Label)
measure: Safety 1: Absence of skin lesions
time frame: 15 minutes after end of anesthesia
description: skin lesions, irritations after removal of the patch at the end of anesthesia (yes / no)
measure: Safety 2: Severity of skin lesions
time frame: 15 minutes after end of anesthesia
description: skin lesions, irritations after removal of the patch at the end of anesthesia (mild/moderate/severe)
measure: Proof of Concept 2: Intubation success
time frame: 5 minutes after start of intubation
description: Successful video-laryngoscopic tracheal intubation
measure: Proof of Concept 3: Intubation success
time frame: 5 minutes after start of intubation
description: Duration of intubation (time in seconds from inserting the video laryngoscope till tracheal tube cuff inflation)
measure: Proof of Concept 4: Intubation success
time frame: 5 minutes after start of intubation
description: Number of video laryngoscopy attempts till successful tracheal tube placement (number of video laryngoscope insertions during an intubation process that are related to the IRRIS operation)
measure: Proof of Concept 5: Ease of use of IRRIS
time frame: 5 minutes after start of intubation
description: Subjective degree of difficulty of the entire intubation process according a Verbal Rating Scale (VRS) assessed by the intubation person (values from 1 = very easy to 10 = extremely difficult)
measure: Proof of Concept 7: Ease of use of IRRIS
time frame: 5 minutes after start of intubation
description: Subjective degree of helpfulness of the visual aid by the device: according a Verbal Rating Scale (VRS) assessed by the intubation person (values from 1 = not helpful at all to 10 = very helpful)
measure: Proof of Concept 8: Intubation success
time frame: 5 minutes after start of intubation
description: Failures: necessity of alternative airway securing or abort of tracheal intubation if initial attempt(s) with IRRIS failed. (yes / no and number and choice of alternative techniques)
arm group label: Study intervention group
arm group type: Experimental
description: All participants will be intubated with a video-laryngiscope by guiding the tracheal tube according to the highlighted Larynx on the Video Screen.
intervention type: Device
intervention name: IRRIS InfraRed - Red Intubation System
description: IRRIS will be attached to the patient's neck skin just beneath the laryngeal prominence. Tracheal intubation will be performed by using a video-laryngoscope in a standardized Fashion and by guiding the tracheal tube into the Larynx by following the visual Signal on the Screen that is caused by IRRIS. The handling of IRRIS and the Performance of tracheal Intubation will be recorded. Patients will be monitored for safety parameters and possible adverse events during the study until recovered and released from the postoperative care unit.
arm group label: Study intervention group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Peter Biro, MD
role: Principal Investigator
affiliation: University Hospital Zurich, Institue of Anesthesiology
facility: 
country: Switzerland
citation: Goto Y, Goto T, Hagiwara Y, Tsugawa Y, Watase H, Okamoto H, Hasegawa K; Japanese Emergency Medicine Network Investigators. Techniques and outcomes of emergency airway management in Japan: An analysis of two multicentre prospective observational studies, 2010-2016. Resuscitation. 2017 May;114:14-20. doi: 10.1016/j.resuscitation.2017.02.009. Epub 2017 Feb 17.
PMID: 28219617
citation: Brown CA 3rd, Bair AE, Pallin DJ, Walls RM; NEAR III Investigators. Techniques, success, and adverse events of emergency department adult intubations. Ann Emerg Med. 2015 Apr;65(4):363-370.e1. doi: 10.1016/j.annemergmed.2014.10.036. Epub 2014 Dec 20. Erratum In: Ann Emerg Med. 2017 May;69(5):540.
PMID: 25533140
citation: Howard-Quijano KJ, Huang YM, Matevosian R, Kaplan MB, Steadman RH. Video-assisted instruction improves the success rate for tracheal intubation by novices. Br J Anaesth. 2008 Oct;101(4):568-72. doi: 10.1093/bja/aen211. Epub 2008 Aug 1.
PMID: 18676418
citation: Song Y, Oh J, Chee Y, Lim T, Kang H, Cho Y. A novel method to position an endotracheal tube at the correct depth using an infrared sensor stylet. Can J Anaesth. 2013 May;60(5):444-9. doi: 10.1007/s12630-013-9898-6. Epub 2013 Feb 1.
PMID: 23370979
citation: El-Sayed IH, Ho JE, Eisele DW. External light guidance for percutaneous dilatational tracheotomy. Head Neck. 2011 Aug;33(8):1206-9. doi: 10.1002/hed.21610. Epub 2011 Mar 16.
PMID: 21413098
citation: Kaplan MB, Ward D, Hagberg CA, Berci G, Hagiike M. Seeing is believing: the importance of video laryngoscopy in teaching and in managing the difficult airway. Surg Endosc. 2006 Apr;20 Suppl 2:S479-83. doi: 10.1007/s00464-006-0038-z. Epub 2006 Mar 16.
PMID: 16544062
responsible party type: Sponsor
sharing ipd: No