<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/NCT02188979</url>
  </required_header>
  <id_info>
    <org_study_id>GLOBE</org_study_id>
    <nct_id>NCT02188979</nct_id>
  </id_info>
  <brief_title>GlideScope With EGRI Assessment in Obese Patients</brief_title>
  <acronym>GLOBE</acronym>
  <official_title>GlideScope Videolaryngoscopy and Pre-Operative Assessment of El-Ganzouri Risk Index for Tracheal Intubation in Morbidly Obese Patients The Prospective Observational GLOBE Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Università degli Studi di Brescia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Università degli Studi di Brescia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      BACKGROUND Unpredicted difficult tracheal intubation (DTI) with Macintosh laryngoscopy occurs&#xD;
      frequently in obese patients. We investigated the incidence of DTI using the GlideScope®&#xD;
      videolaryngoscope (GVL) with an algorithm based on a pre-operative assessment with the El&#xD;
      Ganzouri Risk Index (EGRI).&#xD;
&#xD;
      METHODS We prospectively enrolled morbidly obese patients (BMI&gt;40 kg/m2) undergoing abdominal&#xD;
      surgery. Patients were scheduled for flexible fibre optic bronchoscopic intubation (FFBI) or&#xD;
      GVL intubation if the EGRI score was ≥7 or &lt;7, respectively. The primary outcome was the&#xD;
      occurrence of DTI that was defined as Cormack and Lehane (C&amp;L) grades ≥III, Intubation&#xD;
      Difficulty Scale (IDS)&gt;5 and modified IDS (mIDS)&gt;5. A numeric rating scale (NRS) was also&#xD;
      used. Secondary outcomes included intubation success during the first attempt, the time to&#xD;
      Cormack (TTC), the time to intubation (TTI), failure to intubate, oxygen desaturation and&#xD;
      difficult ventilation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The EGRI, a multivariate risk index that combines seven variables associated with DTI, was&#xD;
      evaluated in all patients during the pre-anaesthesia visit. The results were reported in the&#xD;
      clinical chart. All tracheal intubations in obese patients needing surgery were routinely&#xD;
      performed using GVL. The intubations were performed or assisted by five board-certified&#xD;
      anaesthesiologists who had prior experience with at least 20 GVL intubations, as well as at&#xD;
      least two years of experience with anaesthesia in obese patients. In cases where the GVL&#xD;
      intubation was performed by anaesthesiologists that were in training, the GVL expert was&#xD;
      actively advising the operator during all of the intubating procedures. The standard&#xD;
      equipment included a GVL with blade number three to five and an orotracheal hockey stick tube&#xD;
      with a malleable single-use stylet (Fr 14, Intubating Stylet, DEAS). The standard anaesthesia&#xD;
      induction started with 3-5 minutes of pre-oxygenation using 5 cm H2O PEEP in a 30° head-up&#xD;
      position, as well as induction with fentanyl 3 μg kg -1 (LBW), propofol 2-3 mg kg -1 (LBW)&#xD;
      and suxamethonium 1 mg Kg -1 (TBW). When spontaneous respiration ceased, the patient was mask&#xD;
      ventilated with 100% oxygen. The tube was lubricated and advanced into the mouth under direct&#xD;
      visual guidance to avoid complications, and then, under indirect visual guidance using the&#xD;
      GVL monitor. The correct placement of the cuffed tube was verified using a capnograph and a&#xD;
      stethoscope. The tube sizes were 7.0 for women and 7.5 for men. Each patient was monitored&#xD;
      using an electrocardiogram, non-invasive arterial blood pressure measurement, and pulse&#xD;
      oximetry before both tracheal intubation and anaesthesia induction. The basic demographic&#xD;
      data and airway characteristics necessary to evaluate the primary outcome and to calculate&#xD;
      the EGRI score were registered prior to anaesthesia. Patients with an EGRI score of 7 or&#xD;
      higher were scheduled for elective fibre optic flexible bronchoscopic intubation (FFBI),&#xD;
      while patients with an EGRI score of less than 7 underwent anaesthesia induction and GVL&#xD;
      intubation, according to a predefined algorithm&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">April 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Occurrence of DTI that was defined as Cormack and Lehane (C&amp;L) grades ≥III, Intubation Difficulty Scale (IDS)&gt;5 and modified IDS (mIDS)&gt;5. A numeric rating scale (NRS) was also used.</measure>
    <time_frame>Ten minutes after the intubation</time_frame>
    <description>The primary outcome was the incidence of DTI. Because scores specifically designed to assess DTI with GVL are not available, we used the Cormack and Lehane (C&amp;L) grades ≥III, the Intubation Difficulty Scale (IDS) &gt;5 and a modified IDS (mIDS) &gt;5 to assess DTI. We also conducted a subjective assessment of DTI as rated by the operator on a numeric rating scale (NRS), from 0 (easiest) to 10 (the most difficult procedure).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>frequency of tracheal intubation success during the first attempt</measure>
    <time_frame>Ten minutes after the intubation</time_frame>
    <description>The frequency of intubation success at the first attempt was defined as being when the tracheal intubation was successfully achieved with all the following criteria fulfilled: a single introduction of the laryngoscope and tube progression, C&amp;L I or IIa without external laryngeal displacement, and no need for help by another operator.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the time to Cormack (TTC) and the time to tracheal intubation (TTI).</measure>
    <time_frame>Ten minutes after the intubation</time_frame>
    <description>TTC was measured from the time the instrument entered patient's mouth until the optimal laryngeal view. TTI was measured from the time the instrument entered the patient's mouth until the tube cuff inflation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>intubation failures</measure>
    <time_frame>Ten minutes after the intubation failure</time_frame>
    <description>Failure to intubate was defined as when tracheal intubation proved impossible after three attempts</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>difficult mask ventilation</measure>
    <time_frame>Ten minutes after the intubation</time_frame>
    <description>Difficult ventilation was defined with the use of the Han scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>oxygen desaturation</measure>
    <time_frame>Ten minutes after the intubation</time_frame>
    <description>Oxygen desaturation was defined as an oxygen saturation of less than 90%</description>
  </secondary_outcome>
  <enrollment type="Actual">195</enrollment>
  <condition>Morbid Obesity</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Our patients population is the population of morbidly obese patients scheduled for&#xD;
        bariatric surgery or other non-bariatric abdominal surgical interventions and referring to&#xD;
        the University Division of Anaesthesia and Intensive Care at Spedali Civili of Brescia.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body Mass Index (BMI)&gt;40 kg m-2.&#xD;
&#xD;
          -  Surgery with tracheal intubation scheduled&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &lt; 18 years&#xD;
&#xD;
          -  severe psychological disorders that have the possibility of limiting the patient's&#xD;
             comprehension of information&#xD;
&#xD;
          -  previously impossible mask ventilation or intubation with GVL&#xD;
&#xD;
          -  presence of pharyngo-laryngeal or neck tumours&#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>Alessandro Mosca, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Università degli Studi di Brescia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Elena Cagnazzi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Università degli Studi di Brescia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Federico Pe, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Università degli Studi di Brescia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tiziana Togazzari, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Universitry of Brescia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ottavia Manenti, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Univertsity of Brescia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Francesco Mittempergher, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Università degli Studi di Brescia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Elena Raffetti, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Università degli Studi di Brescia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Francesco Donato, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Università degli Studi di Brescia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nicola Latronico, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Università degli Studi di Brescia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Anaesthesia, Critical Care Medicine and Emergency University of Brescia at Spedali Civili.</name>
      <address>
        <city>Brescia</city>
        <zip>25100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Padwal RS, Klarenbach SW, Wang X, Sharma AM, Karmali S, Birch DW, Majumdar SR. A simple prediction rule for all-cause mortality in a cohort eligible for bariatric surgery. JAMA Surg. 2013 Dec;148(12):1109-15. doi: 10.1001/jamasurg.2013.3953.</citation>
    <PMID>24132685</PMID>
  </reference>
  <reference>
    <citation>Buchwald H, Oien DM. Metabolic/bariatric surgery Worldwide 2008. Obes Surg. 2009 Dec;19(12):1605-11. doi: 10.1007/s11695-009-0014-5.</citation>
    <PMID>19885707</PMID>
  </reference>
  <reference>
    <citation>Nicholson A, Smith AF, Lewis SR, Cook TM. Tracheal intubation with a flexible intubation scope versus other intubation techniques for obese patients requiring general anaesthesia. Cochrane Database Syst Rev. 2014 Jan 17;(1):CD010320. doi: 10.1002/14651858.CD010320.pub2.</citation>
    <PMID>24443105</PMID>
  </reference>
  <reference>
    <citation>Cook TM, MacDougall-Davis SR. Complications and failure of airway management. Br J Anaesth. 2012 Dec;109 Suppl 1:i68-i85. doi: 10.1093/bja/aes393.</citation>
    <PMID>23242753</PMID>
  </reference>
  <reference>
    <citation>Juvin P, Lavaut E, Dupont H, Lefevre P, Demetriou M, Dumoulin JL, Desmonts JM. Difficult tracheal intubation is more common in obese than in lean patients. Anesth Analg. 2003 Aug;97(2):595-600. doi: 10.1213/01.ANE.0000072547.75928.B0.</citation>
    <PMID>12873960</PMID>
  </reference>
  <reference>
    <citation>Kim WH, Ahn HJ, Lee CJ, Shin BS, Ko JS, Choi SJ, Ryu SA. Neck circumference to thyromental distance ratio: a new predictor of difficult intubation in obese patients. Br J Anaesth. 2011 May;106(5):743-8. doi: 10.1093/bja/aer024. Epub 2011 Feb 24.</citation>
    <PMID>21354999</PMID>
  </reference>
  <reference>
    <citation>Serocki G, Neumann T, Scharf E, Dorges V, Cavus E. Indirect videolaryngoscopy with C-MAC D-Blade and GlideScope: a randomized, controlled comparison in patients with suspected difficult airways. Minerva Anestesiol. 2013 Feb;79(2):121-9. Epub 2012 Oct 2.</citation>
    <PMID>23032922</PMID>
  </reference>
  <reference>
    <citation>Cortellazzi P, Minati L, Falcone C, Lamperti M, Caldiroli D. Predictive value of the El-Ganzouri multivariate risk index for difficult tracheal intubation: a comparison of Glidescope videolaryngoscopy and conventional Macintosh laryngoscopy. Br J Anaesth. 2007 Dec;99(6):906-11. doi: 10.1093/bja/aem297. Epub 2007 Oct 25.</citation>
    <PMID>17962241</PMID>
  </reference>
  <reference>
    <citation>el-Ganzouri AR, McCarthy RJ, Tuman KJ, Tanck EN, Ivankovich AD. Preoperative airway assessment: predictive value of a multivariate risk index. Anesth Analg. 1996 Jun;82(6):1197-204. doi: 10.1097/00000539-199606000-00017.</citation>
    <PMID>8638791</PMID>
  </reference>
  <reference>
    <citation>Caldiroli D, Cortellazzi P. A new difficult airway management algorithm based upon the El Ganzouri Risk Index and GlideScope(R) videolaryngoscope. A new look for intubation? Minerva Anestesiol. 2011 Oct;77(10):1011-7. Epub 2011 May 24.</citation>
    <PMID>21610665</PMID>
  </reference>
  <reference>
    <citation>Cooper RM, Pacey JA, Bishop MJ, McCluskey SA. Early clinical experience with a new videolaryngoscope (GlideScope) in 728 patients. Can J Anaesth. 2005 Feb;52(2):191-8. doi: 10.1007/BF03027728.</citation>
    <PMID>15684262</PMID>
  </reference>
  <reference>
    <citation>Maassen R, Lee R, Hermans B, Marcus M, van Zundert A. A comparison of three videolaryngoscopes: the Macintosh laryngoscope blade reduces, but does not replace, routine stylet use for intubation in morbidly obese patients. Anesth Analg. 2009 Nov;109(5):1560-5. doi: 10.1213/ANE.0b013e3181b7303a. Epub 2009 Aug 27.</citation>
    <PMID>19713258</PMID>
  </reference>
  <reference>
    <citation>Serocki G, Bein B, Scholz J, Dorges V. Management of the predicted difficult airway: a comparison of conventional blade laryngoscopy with video-assisted blade laryngoscopy and the GlideScope. Eur J Anaesthesiol. 2010 Jan;27(1):24-30. doi: 10.1097/EJA.0b013e32832d328d.</citation>
    <PMID>19809328</PMID>
  </reference>
  <reference>
    <citation>Andersen LH, Rovsing L, Olsen KS. GlideScope videolaryngoscope vs. Macintosh direct laryngoscope for intubation of morbidly obese patients: a randomized trial. Acta Anaesthesiol Scand. 2011 Oct;55(9):1090-7. doi: 10.1111/j.1399-6576.2011.02498.x. Epub 2011 Sep 8.</citation>
    <PMID>22092206</PMID>
  </reference>
  <reference>
    <citation>Xue FS, Li CW, Zhang GH, Li XY, Sun HT, Liu KP, Liu J, Wang X. GlideScope-assisted awake fibreoptic intubation: initial experience in 13 patients. Anaesthesia. 2006 Oct;61(10):1014-5. doi: 10.1111/j.1365-2044.2006.04809.x. No abstract available.</citation>
    <PMID>16978330</PMID>
  </reference>
  <reference>
    <citation>Ydemann M, Rovsing L, Lindekaer AL, Olsen KS. Intubation of the morbidly obese patient: GlideScope((R)) vs. Fastrach. Acta Anaesthesiol Scand. 2012 Jul;56(6):755-61. doi: 10.1111/j.1399-6576.2012.02693.x. Epub 2012 Apr 23.</citation>
    <PMID>22524487</PMID>
  </reference>
  <reference>
    <citation>DeMaria EJ. Bariatric surgery for morbid obesity. N Engl J Med. 2007 May 24;356(21):2176-83. doi: 10.1056/NEJMct067019. No abstract available.</citation>
    <PMID>17522401</PMID>
  </reference>
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    <citation>Ogden CL, Carroll MD, Curtin LR, McDowell MA, Tabak CJ, Flegal KM. Prevalence of overweight and obesity in the United States, 1999-2004. JAMA. 2006 Apr 5;295(13):1549-55. doi: 10.1001/jama.295.13.1549.</citation>
    <PMID>16595758</PMID>
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    <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>
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  <reference>
    <citation>Han R, Tremper KK, Kheterpal S, O'Reilly M. Grading scale for mask ventilation. Anesthesiology. 2004 Jul;101(1):267. doi: 10.1097/00000542-200407000-00059. No abstract available.</citation>
    <PMID>15220820</PMID>
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    <citation>Sun DA, Warriner CB, Parsons DG, Klein R, Umedaly HS, Moult M. The GlideScope Video Laryngoscope: randomized clinical trial in 200 patients. Br J Anaesth. 2005 Mar;94(3):381-4. doi: 10.1093/bja/aei041. Epub 2004 Nov 26.</citation>
    <PMID>15567809</PMID>
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    <citation>Aziz MF, Healy D, Kheterpal S, Fu RF, Dillman D, Brambrink AM. Routine clinical practice effectiveness of the Glidescope in difficult airway management: an analysis of 2,004 Glidescope intubations, complications, and failures from two institutions. Anesthesiology. 2011 Jan;114(1):34-41. doi: 10.1097/ALN.0b013e3182023eb7.</citation>
    <PMID>21150569</PMID>
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    <citation>Caldiroli D, Molteni F, Sommariva A, Frittoli S, Guanziroli E, Cortellazzi P, Orena EF. Upper limb muscular activity and perceived workload during laryngoscopy: comparison of Glidescope(R) and Macintosh laryngoscopy in manikin: an observational study. Br J Anaesth. 2014 Mar;112(3):563-9. doi: 10.1093/bja/aet347. Epub 2013 Oct 22.</citation>
    <PMID>24148322</PMID>
  </reference>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 6, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 14, 2014</study_first_posted>
  <last_update_submitted>July 10, 2014</last_update_submitted>
  <last_update_submitted_qc>July 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 14, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Università degli Studi di Brescia</investigator_affiliation>
    <investigator_full_name>Elena Cagnazzi</investigator_full_name>
    <investigator_title>Medical Doctor Anesthesiologist</investigator_title>
  </responsible_party>
  <keyword>airway</keyword>
  <keyword>equipment - laryngoscopes</keyword>
  <keyword>intubation - tracheal</keyword>
  <keyword>obesity.</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity, Morbid</mesh_term>
  </condition_browse>
  <!-- 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/NCT02188979
org study id: GLOBE
nct id: NCT02188979
lead sponsor: 
has dmc: No
BACKGROUND Unpredicted difficult tracheal intubation (DTI) with Macintosh laryngoscopy occurs
      frequently in obese patients. We investigated the incidence of DTI using the GlideScope®
      videolaryngoscope (GVL) with an algorithm based on a pre-operative assessment with the El
      Ganzouri Risk Index (EGRI).

      METHODS We prospectively enrolled morbidly obese patients (BMI>40 kg/m2) undergoing abdominal
      surgery. Patients were scheduled for flexible fibre optic bronchoscopic intubation (FFBI) or
      GVL intubation if the EGRI score was ≥7 or <7, respectively. The primary outcome was the
      occurrence of DTI that was defined as Cormack and Lehane (C&L) grades ≥III, Intubation
      Difficulty Scale (IDS)>5 and modified IDS (mIDS)>5. A numeric rating scale (NRS) was also
      used. Secondary outcomes included intubation success during the first attempt, the time to
      Cormack (TTC), the time to intubation (TTI), failure to intubate, oxygen desaturation and
      difficult ventilation.
The EGRI, a multivariate risk index that combines seven variables associated with DTI, was
      evaluated in all patients during the pre-anaesthesia visit. The results were reported in the
      clinical chart. All tracheal intubations in obese patients needing surgery were routinely
      performed using GVL. The intubations were performed or assisted by five board-certified
      anaesthesiologists who had prior experience with at least 20 GVL intubations, as well as at
      least two years of experience with anaesthesia in obese patients. In cases where the GVL
      intubation was performed by anaesthesiologists that were in training, the GVL expert was
      actively advising the operator during all of the intubating procedures. The standard
      equipment included a GVL with blade number three to five and an orotracheal hockey stick tube
      with a malleable single-use stylet (Fr 14, Intubating Stylet, DEAS). The standard anaesthesia
      induction started with 3-5 minutes of pre-oxygenation using 5 cm H2O PEEP in a 30° head-up
      position, as well as induction with fentanyl 3 μg kg -1 (LBW), propofol 2-3 mg kg -1 (LBW)
      and suxamethonium 1 mg Kg -1 (TBW). When spontaneous respiration ceased, the patient was mask
      ventilated with 100% oxygen. The tube was lubricated and advanced into the mouth under direct
      visual guidance to avoid complications, and then, under indirect visual guidance using the
      GVL monitor. The correct placement of the cuffed tube was verified using a capnograph and a
      stethoscope. The tube sizes were 7.0 for women and 7.5 for men. Each patient was monitored
      using an electrocardiogram, non-invasive arterial blood pressure measurement, and pulse
      oximetry before both tracheal intubation and anaesthesia induction. The basic demographic
      data and airway characteristics necessary to evaluate the primary outcome and to calculate
      the EGRI score were registered prior to anaesthesia. Patients with an EGRI score of 7 or
      higher were scheduled for elective fibre optic flexible bronchoscopic intubation (FFBI),
      while patients with an EGRI score of less than 7 underwent anaesthesia induction and GVL
      intubation, according to a predefined algorithm
observational model: Case-Only
time perspective: Prospective
measure: Occurrence of DTI that was defined as Cormack and Lehane (C&L) grades ≥III, Intubation Difficulty Scale (IDS)>5 and modified IDS (mIDS)>5. A numeric rating scale (NRS) was also used.
time frame: Ten minutes after the intubation
description: The primary outcome was the incidence of DTI. Because scores specifically designed to assess DTI with GVL are not available, we used the Cormack and Lehane (C&L) grades ≥III, the Intubation Difficulty Scale (IDS) >5 and a modified IDS (mIDS) >5 to assess DTI. We also conducted a subjective assessment of DTI as rated by the operator on a numeric rating scale (NRS), from 0 (easiest) to 10 (the most difficult procedure).
measure: frequency of tracheal intubation success during the first attempt
time frame: Ten minutes after the intubation
description: The frequency of intubation success at the first attempt was defined as being when the tracheal intubation was successfully achieved with all the following criteria fulfilled: a single introduction of the laryngoscope and tube progression, C&L I or IIa without external laryngeal displacement, and no need for help by another operator.
measure: the time to Cormack (TTC) and the time to tracheal intubation (TTI).
time frame: Ten minutes after the intubation
description: TTC was measured from the time the instrument entered patient's mouth until the optimal laryngeal view. TTI was measured from the time the instrument entered the patient's mouth until the tube cuff inflation.
measure: intubation failures
time frame: Ten minutes after the intubation failure
description: Failure to intubate was defined as when tracheal intubation proved impossible after three attempts
measure: difficult mask ventilation
time frame: Ten minutes after the intubation
description: Difficult ventilation was defined with the use of the Han scale
measure: oxygen desaturation
time frame: Ten minutes after the intubation
description: Oxygen desaturation was defined as an oxygen saturation of less than 90%
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Alessandro Mosca, MD
role: Principal Investigator
affiliation: Università degli Studi di Brescia
last name: Elena Cagnazzi, MD
role: Principal Investigator
affiliation: Università degli Studi di Brescia
last name: Federico Pe, MD
role: Principal Investigator
affiliation: Università degli Studi di Brescia
last name: Tiziana Togazzari, MD
role: Study Chair
affiliation: Universitry of Brescia
last name: Ottavia Manenti, MD
role: Study Chair
affiliation: Univertsity of Brescia
last name: Francesco Mittempergher, MD
role: Study Chair
affiliation: Università degli Studi di Brescia
last name: Elena Raffetti, MD
role: Study Chair
affiliation: Università degli Studi di Brescia
last name: Francesco Donato, Professor
role: Study Chair
affiliation: Università degli Studi di Brescia
last name: Nicola Latronico, Professor
role: Study Director
affiliation: Università degli Studi di Brescia
facility: 
country: Italy
citation: Padwal RS, Klarenbach SW, Wang X, Sharma AM, Karmali S, Birch DW, Majumdar SR. A simple prediction rule for all-cause mortality in a cohort eligible for bariatric surgery. JAMA Surg. 2013 Dec;148(12):1109-15. doi: 10.1001/jamasurg.2013.3953.
PMID: 24132685
citation: Buchwald H, Oien DM. Metabolic/bariatric surgery Worldwide 2008. Obes Surg. 2009 Dec;19(12):1605-11. doi: 10.1007/s11695-009-0014-5.
PMID: 19885707
citation: Nicholson A, Smith AF, Lewis SR, Cook TM. Tracheal intubation with a flexible intubation scope versus other intubation techniques for obese patients requiring general anaesthesia. Cochrane Database Syst Rev. 2014 Jan 17;(1):CD010320. doi: 10.1002/14651858.CD010320.pub2.
PMID: 24443105
citation: Cook TM, MacDougall-Davis SR. Complications and failure of airway management. Br J Anaesth. 2012 Dec;109 Suppl 1:i68-i85. doi: 10.1093/bja/aes393.
PMID: 23242753
citation: Juvin P, Lavaut E, Dupont H, Lefevre P, Demetriou M, Dumoulin JL, Desmonts JM. Difficult tracheal intubation is more common in obese than in lean patients. Anesth Analg. 2003 Aug;97(2):595-600. doi: 10.1213/01.ANE.0000072547.75928.B0.
PMID: 12873960
citation: Kim WH, Ahn HJ, Lee CJ, Shin BS, Ko JS, Choi SJ, Ryu SA. Neck circumference to thyromental distance ratio: a new predictor of difficult intubation in obese patients. Br J Anaesth. 2011 May;106(5):743-8. doi: 10.1093/bja/aer024. Epub 2011 Feb 24.
PMID: 21354999
citation: Serocki G, Neumann T, Scharf E, Dorges V, Cavus E. Indirect videolaryngoscopy with C-MAC D-Blade and GlideScope: a randomized, controlled comparison in patients with suspected difficult airways. Minerva Anestesiol. 2013 Feb;79(2):121-9. Epub 2012 Oct 2.
PMID: 23032922
citation: Cortellazzi P, Minati L, Falcone C, Lamperti M, Caldiroli D. Predictive value of the El-Ganzouri multivariate risk index for difficult tracheal intubation: a comparison of Glidescope videolaryngoscopy and conventional Macintosh laryngoscopy. Br J Anaesth. 2007 Dec;99(6):906-11. doi: 10.1093/bja/aem297. Epub 2007 Oct 25.
PMID: 17962241
citation: el-Ganzouri AR, McCarthy RJ, Tuman KJ, Tanck EN, Ivankovich AD. Preoperative airway assessment: predictive value of a multivariate risk index. Anesth Analg. 1996 Jun;82(6):1197-204. doi: 10.1097/00000539-199606000-00017.
PMID: 8638791
citation: Caldiroli D, Cortellazzi P. A new difficult airway management algorithm based upon the El Ganzouri Risk Index and GlideScope(R) videolaryngoscope. A new look for intubation? Minerva Anestesiol. 2011 Oct;77(10):1011-7. Epub 2011 May 24.
PMID: 21610665
citation: Cooper RM, Pacey JA, Bishop MJ, McCluskey SA. Early clinical experience with a new videolaryngoscope (GlideScope) in 728 patients. Can J Anaesth. 2005 Feb;52(2):191-8. doi: 10.1007/BF03027728.
PMID: 15684262
citation: Maassen R, Lee R, Hermans B, Marcus M, van Zundert A. A comparison of three videolaryngoscopes: the Macintosh laryngoscope blade reduces, but does not replace, routine stylet use for intubation in morbidly obese patients. Anesth Analg. 2009 Nov;109(5):1560-5. doi: 10.1213/ANE.0b013e3181b7303a. Epub 2009 Aug 27.
PMID: 19713258
citation: Serocki G, Bein B, Scholz J, Dorges V. Management of the predicted difficult airway: a comparison of conventional blade laryngoscopy with video-assisted blade laryngoscopy and the GlideScope. Eur J Anaesthesiol. 2010 Jan;27(1):24-30. doi: 10.1097/EJA.0b013e32832d328d.
PMID: 19809328
citation: Andersen LH, Rovsing L, Olsen KS. GlideScope videolaryngoscope vs. Macintosh direct laryngoscope for intubation of morbidly obese patients: a randomized trial. Acta Anaesthesiol Scand. 2011 Oct;55(9):1090-7. doi: 10.1111/j.1399-6576.2011.02498.x. Epub 2011 Sep 8.
PMID: 22092206
citation: Xue FS, Li CW, Zhang GH, Li XY, Sun HT, Liu KP, Liu J, Wang X. GlideScope-assisted awake fibreoptic intubation: initial experience in 13 patients. Anaesthesia. 2006 Oct;61(10):1014-5. doi: 10.1111/j.1365-2044.2006.04809.x. No abstract available.
PMID: 16978330
citation: Ydemann M, Rovsing L, Lindekaer AL, Olsen KS. Intubation of the morbidly obese patient: GlideScope((R)) vs. Fastrach. Acta Anaesthesiol Scand. 2012 Jul;56(6):755-61. doi: 10.1111/j.1399-6576.2012.02693.x. Epub 2012 Apr 23.
PMID: 22524487
citation: DeMaria EJ. Bariatric surgery for morbid obesity. N Engl J Med. 2007 May 24;356(21):2176-83. doi: 10.1056/NEJMct067019. No abstract available.
PMID: 17522401
citation: Ogden CL, Carroll MD, Curtin LR, McDowell MA, Tabak CJ, Flegal KM. Prevalence of overweight and obesity in the United States, 1999-2004. JAMA. 2006 Apr 5;295(13):1549-55. doi: 10.1001/jama.295.13.1549.
PMID: 16595758
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: Han R, Tremper KK, Kheterpal S, O'Reilly M. Grading scale for mask ventilation. Anesthesiology. 2004 Jul;101(1):267. doi: 10.1097/00000542-200407000-00059. No abstract available.
PMID: 15220820
citation: Sun DA, Warriner CB, Parsons DG, Klein R, Umedaly HS, Moult M. The GlideScope Video Laryngoscope: randomized clinical trial in 200 patients. Br J Anaesth. 2005 Mar;94(3):381-4. doi: 10.1093/bja/aei041. Epub 2004 Nov 26.
PMID: 15567809
citation: Aziz MF, Healy D, Kheterpal S, Fu RF, Dillman D, Brambrink AM. Routine clinical practice effectiveness of the Glidescope in difficult airway management: an analysis of 2,004 Glidescope intubations, complications, and failures from two institutions. Anesthesiology. 2011 Jan;114(1):34-41. doi: 10.1097/ALN.0b013e3182023eb7.
PMID: 21150569
citation: Caldiroli D, Molteni F, Sommariva A, Frittoli S, Guanziroli E, Cortellazzi P, Orena EF. Upper limb muscular activity and perceived workload during laryngoscopy: comparison of Glidescope(R) and Macintosh laryngoscopy in manikin: an observational study. Br J Anaesth. 2014 Mar;112(3):563-9. doi: 10.1093/bja/aet347. Epub 2013 Oct 22.
PMID: 24148322
responsible party type: Principal Investigator
investigator affiliation: Università degli Studi di Brescia
investigator full name: Elena Cagnazzi
investigator title: Medical Doctor Anesthesiologist
mesh term: Obesity, Morbid