<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/NCT04410289</url>
  </required_header>
  <id_info>
    <org_study_id>13188</org_study_id>
    <nct_id>NCT04410289</nct_id>
  </id_info>
  <brief_title>Defining the 'Sniffing Position&quot; in Infants and Toddlers - A Pilot Study</brief_title>
  <official_title>A Prospective Randomized Pilot Study to Define and Validate the Standard 'Sniffing Position' in Infants and Toddlers.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tufts Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tufts Medical Center</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 &quot;sniffing position&quot; is widely accepted as a favorable position for direct laryngoscopy&#xD;
      (DL) in both pediatric and adult patients. External anatomical markers are well documented to&#xD;
      confirm proper 'sniffing position' in adults, but data on their use in the pediatric&#xD;
      population is sparse. The investigators propose to define these markers in young children and&#xD;
      investigate whether patients positioned using this standardized approach have better&#xD;
      intubating conditions than those positioned randomly per the preference of the&#xD;
      anesthesiologist.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The procedure of endotracheal intubation in adults and children is a continuum, and begins&#xD;
      with proper head positioning prior to direct laryngoscopy (DL). It is an accepted paradigm&#xD;
      that proper positioning optimizes intubating conditions, and decreases subsequent airway&#xD;
      maneuvers and manipulation.&#xD;
&#xD;
      The sniffing position is an accepted airway positioning concept in pediatric airway&#xD;
      management, and continues to be recommended by experts and textbooks in the field. Anatomical&#xD;
      peculiarities such as the large head relative to the torso in infants and toddlers is assumed&#xD;
      to put the head in proper position when gently extended. However, reproducible parameters to&#xD;
      confirm optimal head positioning remain vague and unclear. In the absence of objective and&#xD;
      measurable markers, practitioners position infants and toddlers according to their individual&#xD;
      preferences, and as such the procedure lacks definition and objective clarity.&#xD;
&#xD;
      The investigators plan to recruit 40 healthy patients between the ages of 1 month - 48 months&#xD;
      and randomize them to be positioned either according to a predetermined algorithm or&#xD;
      positioned freely according to the provider's preference. Patients randomized to the&#xD;
      intervention group will be positioned with the aim to horizontally align the external&#xD;
      auditory meatus (EAM) with the sternal notch (SN).&#xD;
&#xD;
      In summary, the study aims to define the sniffing position for infants and toddlers using&#xD;
      reproducible objective secondary markers, and investigate whether a systematic approach to&#xD;
      positioning using such markers improves direct laryngoscopic outcomes in the young pediatric&#xD;
      patient population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2019</start_date>
  <completion_date type="Actual">December 26, 2019</completion_date>
  <primary_completion_date type="Actual">November 30, 2019</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>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in Intubation Difficulty Scale (IDS) Score</measure>
    <time_frame>The brief time involved (5-10 minutes) involving the process of head positioning, direct laryngoscopy and endotracheal intubation.</time_frame>
    <description>To assess the difference in IDS scores between the study and control groups</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Angles of Deviation of the EAM-SN plane and Chin-Sinciput Plane from the Horizontal</measure>
    <time_frame>Post-hoc analysis using a computer program to calculate angles. 10 minutes per patient.</time_frame>
    <description>Secondary outcome was to analyze and compare the degree of alignment or nonalignment of the EAM-SN plane and the sinciput-chin plane in both groups. Angles of deviation of the EAM-SN and chin-sinciput plane were measured in each cohort based on photographic data collected. A positive angle deviation indicated head flexion and a negative angle indicated head extension.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Airway Management</condition>
  <condition>Infant ALL</condition>
  <condition>Children, Only</condition>
  <condition>Endotracheal Intubation</condition>
  <arm_group>
    <arm_group_label>Intervention Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After induction of general anesthesia, and prior to direct laryngoscopy, patients in the intervention group were positioned using props horizontally aligning the external auditory meatus (EAM) with the sternal notch (SN) and the chin with the sinciput. A lateral side-profile photograph was taken for latter analysis and an Intubation Difficulty Scale (IDS) score card completed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>After induction of general anesthesia, and prior to direct laryngoscopy, patients in the control group were positioned freely according to the provider's preference. A lateral side-profile photograph was taken for latter analysis and an Intubation Difficulty Scale (IDS) score card completed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Airway positioning per specified protocol followed by Direct Laryngoscopy and Endotracheal Intubation</intervention_name>
    <description>Positioning of the patient's head and neck for the purpose of direct laryngoscopy and endotracheal intubation</description>
    <arm_group_label>Intervention Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Airway positioning per provider preference followed by Direct Laryngoscopy and Endotracheal Intubation</intervention_name>
    <description>Positioning of the patient's head and neck for the purpose of direct laryngoscopy and endotracheal intubation</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy infants and toddlers undergoing non-emergent surgery under general anesthesia&#xD;
             with an oral endotracheal tube&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  neonates (infants under 1 month of age), infants and toddlers with congenital&#xD;
             syndromes affecting the airway, and patients undergoing emergency surgery.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>48 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aman Kalra, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tufts Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tufts Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Akihisa Y, Hoshijima H, Maruyama K, Koyama Y, Andoh T. Effects of sniffing position for tracheal intubation: a meta-analysis of randomized controlled trials. Am J Emerg Med. 2015 Nov;33(11):1606-11. doi: 10.1016/j.ajem.2015.06.049. Epub 2015 Jun 23.</citation>
    <PMID>26227445</PMID>
  </reference>
  <reference>
    <citation>El-Orbany M, Woehlck H, Salem MR. Head and neck position for direct laryngoscopy. Anesth Analg. 2011 Jul;113(1):103-9. doi: 10.1213/ANE.0b013e31821c7e9c. Epub 2011 May 19.</citation>
    <PMID>21596871</PMID>
  </reference>
  <reference>
    <citation>Greenland KB, Eley V, Edwards MJ, Allen P, Irwin MG. The origins of the sniffing position and the Three Axes Alignment Theory for direct laryngoscopy. Anaesth Intensive Care. 2008 Jul;36 Suppl 1:23-7. doi: 10.1177/0310057X0803601s05.</citation>
    <PMID>18724555</PMID>
  </reference>
  <reference>
    <citation>Greenland KB, Edwards MJ, Hutton NJ. External auditory meatus-sternal notch relationship in adults in the sniffing position: a magnetic resonance imaging study. Br J Anaesth. 2010 Feb;104(2):268-9. doi: 10.1093/bja/aep390. No abstract available.</citation>
    <PMID>20086071</PMID>
  </reference>
  <reference>
    <citation>Prakash S, Rapsang AG, Mahajan S, Bhattacharjee S, Singh R, Gogia AR. Comparative evaluation of the sniffing position with simple head extension for laryngoscopic view and intubation difficulty in adults undergoing elective surgery. Anesthesiol Res Pract. 2011;2011:297913. doi: 10.1155/2011/297913. Epub 2011 Oct 29.</citation>
    <PMID>22110497</PMID>
  </reference>
  <reference>
    <citation>Collins JS, Lemmens HJ, Brodsky JB, Brock-Utne JG, Levitan RM. Laryngoscopy and morbid obesity: a comparison of the &quot;sniff&quot; and &quot;ramped&quot; positions. Obes Surg. 2004 Oct;14(9):1171-5. doi: 10.1381/0960892042386869.</citation>
    <PMID>15527629</PMID>
  </reference>
  <reference>
    <citation>Horton WA, Fahy L, Charters P. Defining a standard intubating position using &quot;angle finder&quot;. Br J Anaesth. 1989 Jan;62(1):6-12. doi: 10.1093/bja/62.1.6.</citation>
    <PMID>2917111</PMID>
  </reference>
  <reference>
    <citation>Kim EH, Lee JH, Song IK, Kim JT, Kim BR, Kim HS. Effect of head position on laryngeal visualisation with the McGrath MAC videolaryngoscope in paediatric patients: A randomised controlled trial. Eur J Anaesthesiol. 2016 Jul;33(7):528-34. doi: 10.1097/EJA.0000000000000448.</citation>
    <PMID>26986776</PMID>
  </reference>
  <reference>
    <citation>Vialet R, Nau A, Chaumoitre K, Martin C. Effects of head posture on the oral, pharyngeal and laryngeal axis alignment in infants and young children by magnetic resonance imaging. Paediatr Anaesth. 2008 Jun;18(6):525-31. doi: 10.1111/j.1460-9592.2008.02530.x. Epub 2008 Mar 18.</citation>
    <PMID>18363622</PMID>
  </reference>
  <reference>
    <citation>Adnet F, Borron SW, Racine SX, Clemessy JL, Fournier JL, Plaisance P, Lapandry C. The intubation difficulty scale (IDS): proposal and evaluation of a new score characterizing the complexity of endotracheal intubation. Anesthesiology. 1997 Dec;87(6):1290-7. doi: 10.1097/00000542-199712000-00005.</citation>
    <PMID>9416711</PMID>
  </reference>
  <reference>
    <citation>Greenland KB, Edwards MJ, Hutton NJ, Challis VJ, Irwin MG, Sleigh JW. Changes in airway configuration with different head and neck positions using magnetic resonance imaging of normal airways: a new concept with possible clinical applications. Br J Anaesth. 2010 Nov;105(5):683-90. doi: 10.1093/bja/aeq239. Epub 2010 Sep 15.</citation>
    <PMID>20846964</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>June 1, 2020</last_update_submitted>
  <last_update_submitted_qc>June 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pediatric intubation</keyword>
  <keyword>direct laryngoscopy</keyword>
  <keyword>sniffing position</keyword>
  <keyword>external auditory meatus</keyword>
  <keyword>pediatric anesthesia</keyword>
  <keyword>pediatric airway management</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04410289
org study id: 13188
nct id: NCT04410289
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The "sniffing position" is widely accepted as a favorable position for direct laryngoscopy
      (DL) in both pediatric and adult patients. External anatomical markers are well documented to
      confirm proper 'sniffing position' in adults, but data on their use in the pediatric
      population is sparse. The investigators propose to define these markers in young children and
      investigate whether patients positioned using this standardized approach have better
      intubating conditions than those positioned randomly per the preference of the
      anesthesiologist.
The procedure of endotracheal intubation in adults and children is a continuum, and begins
      with proper head positioning prior to direct laryngoscopy (DL). It is an accepted paradigm
      that proper positioning optimizes intubating conditions, and decreases subsequent airway
      maneuvers and manipulation.

      The sniffing position is an accepted airway positioning concept in pediatric airway
      management, and continues to be recommended by experts and textbooks in the field. Anatomical
      peculiarities such as the large head relative to the torso in infants and toddlers is assumed
      to put the head in proper position when gently extended. However, reproducible parameters to
      confirm optimal head positioning remain vague and unclear. In the absence of objective and
      measurable markers, practitioners position infants and toddlers according to their individual
      preferences, and as such the procedure lacks definition and objective clarity.

      The investigators plan to recruit 40 healthy patients between the ages of 1 month - 48 months
      and randomize them to be positioned either according to a predetermined algorithm or
      positioned freely according to the provider's preference. Patients randomized to the
      intervention group will be positioned with the aim to horizontally align the external
      auditory meatus (EAM) with the sternal notch (SN).

      In summary, the study aims to define the sniffing position for infants and toddlers using
      reproducible objective secondary markers, and investigate whether a systematic approach to
      positioning using such markers improves direct laryngoscopic outcomes in the young pediatric
      patient population.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Difference in Intubation Difficulty Scale (IDS) Score
time frame: The brief time involved (5-10 minutes) involving the process of head positioning, direct laryngoscopy and endotracheal intubation.
description: To assess the difference in IDS scores between the study and control groups
measure: Angles of Deviation of the EAM-SN plane and Chin-Sinciput Plane from the Horizontal
time frame: Post-hoc analysis using a computer program to calculate angles. 10 minutes per patient.
description: Secondary outcome was to analyze and compare the degree of alignment or nonalignment of the EAM-SN plane and the sinciput-chin plane in both groups. Angles of deviation of the EAM-SN and chin-sinciput plane were measured in each cohort based on photographic data collected. A positive angle deviation indicated head flexion and a negative angle indicated head extension.
arm group label: Intervention Group
arm group type: Experimental
description: After induction of general anesthesia, and prior to direct laryngoscopy, patients in the intervention group were positioned using props horizontally aligning the external auditory meatus (EAM) with the sternal notch (SN) and the chin with the sinciput. A lateral side-profile photograph was taken for latter analysis and an Intubation Difficulty Scale (IDS) score card completed.
arm group label: Control Group
arm group type: Active Comparator
description: After induction of general anesthesia, and prior to direct laryngoscopy, patients in the control group were positioned freely according to the provider's preference. A lateral side-profile photograph was taken for latter analysis and an Intubation Difficulty Scale (IDS) score card completed.
intervention type: Procedure
intervention name: Airway positioning per specified protocol followed by Direct Laryngoscopy and Endotracheal Intubation
description: Positioning of the patient's head and neck for the purpose of direct laryngoscopy and endotracheal intubation
arm group label: Intervention Group
intervention type: Procedure
intervention name: Airway positioning per provider preference followed by Direct Laryngoscopy and Endotracheal Intubation
description: Positioning of the patient's head and neck for the purpose of direct laryngoscopy and endotracheal intubation
arm group label: Control Group
criteria: 
gender: All
minimum age: 1 Month
maximum age: 48 Months
healthy volunteers: No
last name: Aman Kalra, MD
role: Principal Investigator
affiliation: Tufts Medical Center
facility: 
country: United States
citation: Akihisa Y, Hoshijima H, Maruyama K, Koyama Y, Andoh T. Effects of sniffing position for tracheal intubation: a meta-analysis of randomized controlled trials. Am J Emerg Med. 2015 Nov;33(11):1606-11. doi: 10.1016/j.ajem.2015.06.049. Epub 2015 Jun 23.
PMID: 26227445
citation: El-Orbany M, Woehlck H, Salem MR. Head and neck position for direct laryngoscopy. Anesth Analg. 2011 Jul;113(1):103-9. doi: 10.1213/ANE.0b013e31821c7e9c. Epub 2011 May 19.
PMID: 21596871
citation: Greenland KB, Eley V, Edwards MJ, Allen P, Irwin MG. The origins of the sniffing position and the Three Axes Alignment Theory for direct laryngoscopy. Anaesth Intensive Care. 2008 Jul;36 Suppl 1:23-7. doi: 10.1177/0310057X0803601s05.
PMID: 18724555
citation: Greenland KB, Edwards MJ, Hutton NJ. External auditory meatus-sternal notch relationship in adults in the sniffing position: a magnetic resonance imaging study. Br J Anaesth. 2010 Feb;104(2):268-9. doi: 10.1093/bja/aep390. No abstract available.
PMID: 20086071
citation: Prakash S, Rapsang AG, Mahajan S, Bhattacharjee S, Singh R, Gogia AR. Comparative evaluation of the sniffing position with simple head extension for laryngoscopic view and intubation difficulty in adults undergoing elective surgery. Anesthesiol Res Pract. 2011;2011:297913. doi: 10.1155/2011/297913. Epub 2011 Oct 29.
PMID: 22110497
citation: Collins JS, Lemmens HJ, Brodsky JB, Brock-Utne JG, Levitan RM. Laryngoscopy and morbid obesity: a comparison of the "sniff" and "ramped" positions. Obes Surg. 2004 Oct;14(9):1171-5. doi: 10.1381/0960892042386869.
PMID: 15527629
citation: Horton WA, Fahy L, Charters P. Defining a standard intubating position using "angle finder". Br J Anaesth. 1989 Jan;62(1):6-12. doi: 10.1093/bja/62.1.6.
PMID: 2917111
citation: Kim EH, Lee JH, Song IK, Kim JT, Kim BR, Kim HS. Effect of head position on laryngeal visualisation with the McGrath MAC videolaryngoscope in paediatric patients: A randomised controlled trial. Eur J Anaesthesiol. 2016 Jul;33(7):528-34. doi: 10.1097/EJA.0000000000000448.
PMID: 26986776
citation: Vialet R, Nau A, Chaumoitre K, Martin C. Effects of head posture on the oral, pharyngeal and laryngeal axis alignment in infants and young children by magnetic resonance imaging. Paediatr Anaesth. 2008 Jun;18(6):525-31. doi: 10.1111/j.1460-9592.2008.02530.x. Epub 2008 Mar 18.
PMID: 18363622
citation: Adnet F, Borron SW, Racine SX, Clemessy JL, Fournier JL, Plaisance P, Lapandry C. The intubation difficulty scale (IDS): proposal and evaluation of a new score characterizing the complexity of endotracheal intubation. Anesthesiology. 1997 Dec;87(6):1290-7. doi: 10.1097/00000542-199712000-00005.
PMID: 9416711
citation: Greenland KB, Edwards MJ, Hutton NJ, Challis VJ, Irwin MG, Sleigh JW. Changes in airway configuration with different head and neck positions using magnetic resonance imaging of normal airways: a new concept with possible clinical applications. Br J Anaesth. 2010 Nov;105(5):683-90. doi: 10.1093/bja/aeq239. Epub 2010 Sep 15.
PMID: 20846964
responsible party type: Sponsor
sharing ipd: Undecided