<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/NCT03752593</url>
  </required_header>
  <id_info>
    <org_study_id>KHUH/Anesthesia</org_study_id>
    <nct_id>NCT03752593</nct_id>
  </id_info>
  <brief_title>The Incidence of Difficult Intubation in Obese Versus Non-obese Patients</brief_title>
  <official_title>The Incidence of Difficult Intubation in Obese Versus Non-obese Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King Hamad University Hospital, Bahrain</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>King Hamad University Hospital, Bahrain</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of our study is to identify the incidence of difficult endotracheal intubation in&#xD;
      patients with normal BMI undergoing surgery under general anaesthesia in our hospital and&#xD;
      compare it to that of obese patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 8, 2016</start_date>
  <completion_date type="Actual">November 8, 2018</completion_date>
  <primary_completion_date type="Actual">October 8, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of difficulty in airway management</measure>
    <time_frame>two years</time_frame>
    <description>Assessment of Cormack Lehanne grading (intubation difficulty scale) IDS.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">200</enrollment>
  <condition>Airway Obstruction</condition>
  <arm_group>
    <arm_group_label>Obese</arm_group_label>
    <description>Patients with a BMI of greater than 30 who are presenting to the hospital for any surgical procedure requiring general anesthesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-Obese</arm_group_label>
    <description>Patients with a BMI of less than 30 who are presenting to the hospital for any surgical procedure requiring general anesthesia</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ET Tube</intervention_name>
    <description>Patients with a BMI of greater than 30 or less than who are presenting to the hospital for any surgical procedure requiring general anesthesia</description>
    <arm_group_label>Non-Obese</arm_group_label>
    <arm_group_label>Obese</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Heterogeneous group representing the general population of Muharraq&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Elective surgery&#xD;
&#xD;
          -  BMI&lt; 30 for Normal BMI group&#xD;
&#xD;
          -  BMI &gt; 30 for Obese group&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known previous difficult airway&#xD;
&#xD;
          -  Pediatric patients.&#xD;
&#xD;
          -  Emergency patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>King Hamad University Hospital</name>
      <address>
        <city>Muharraq</city>
        <zip>24343</zip>
        <country>Bahrain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bahrain</country>
  </location_countries>
  <reference>
    <citation>Murphy C, Wong DT. Airway management and oxygenation in obese patients. Can J Anaesth. 2013 Sep;60(9):929-45. doi: 10.1007/s12630-013-9991-x. Epub 2013 Jul 9.</citation>
    <PMID>23836064</PMID>
  </reference>
  <reference>
    <citation>Lundstrom LH. Detection of risk factors for difficult tracheal intubation. Dan Med J. 2012 Apr;59(4):B4431.</citation>
    <PMID>22459727</PMID>
  </reference>
  <reference>
    <citation>Shiga T, Wajima Z, Inoue T, Sakamoto A. Predicting difficult intubation in apparently normal patients: a meta-analysis of bedside screening test performance. Anesthesiology. 2005 Aug;103(2):429-37. doi: 10.1097/00000542-200508000-00027.</citation>
    <PMID>16052126</PMID>
  </reference>
  <reference>
    <citation>Lavi R, Segal D, Ziser A. Predicting difficult airways using the intubation difficulty scale: a study comparing obese and non-obese patients. J Clin Anesth. 2009 Jun;21(4):264-7. doi: 10.1016/j.jclinane.2008.08.021. Epub 2009 Jun 6.</citation>
    <PMID>19502026</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>De Jong A, Molinari N, Pouzeratte Y, Verzilli D, Chanques G, Jung B, Futier E, Perrigault PF, Colson P, Capdevila X, Jaber S. Difficult intubation in obese patients: incidence, risk factors, and complications in the operating theatre and in intensive care units. Br J Anaesth. 2015 Feb;114(2):297-306. doi: 10.1093/bja/aeu373. Epub 2014 Nov 27.</citation>
    <PMID>25431308</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>Hashim MM, Ismail MA, Esmat AM, Adeel S. Difficult tracheal intubation in bariatric surgery patients, a myth or reality? Br J Anaesth. 2016 Apr;116(4):557-8. doi: 10.1093/bja/aew039. No abstract available.</citation>
    <PMID>26994235</PMID>
  </reference>
  <reference>
    <citation>Karkouti K, Rose DK, Wigglesworth D, Cohen MM. Predicting difficult intubation: a multivariable analysis. Can J Anaesth. 2000 Aug;47(8):730-9. doi: 10.1007/BF03019474.</citation>
    <PMID>10958088</PMID>
  </reference>
  <reference>
    <citation>Brodsky JB, Lemmens HJ, Brock-Utne JG, Vierra M, Saidman LJ. Morbid obesity and tracheal intubation. Anesth Analg. 2002 Mar;94(3):732-6; table of contents. doi: 10.1097/00000539-200203000-00047.</citation>
    <PMID>11867407</PMID>
  </reference>
  <reference>
    <citation>Bond A. Obesity and difficult intubation. Anaesth Intensive Care. 1993 Dec;21(6):828-30. doi: 10.1177/0310057X9302100614. No abstract available.</citation>
    <PMID>8122742</PMID>
  </reference>
  <reference>
    <citation>Benumof JL. Management of the difficult adult airway. With special emphasis on awake tracheal intubation. Anesthesiology. 1991 Dec;75(6):1087-110. doi: 10.1097/00000542-199112000-00021. Erratum In: Anesthesiology 1993 Jan;78(1):224.</citation>
    <PMID>1824555</PMID>
  </reference>
  <reference>
    <citation>Cormack RS, Lehane J. Difficult tracheal intubation in obstetrics. Anaesthesia. 1984 Nov;39(11):1105-11.</citation>
    <PMID>6507827</PMID>
  </reference>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 26, 2018</study_first_posted>
  <last_update_submitted>October 21, 2019</last_update_submitted>
  <last_update_submitted_qc>October 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>King Hamad University Hospital, Bahrain</investigator_affiliation>
    <investigator_full_name>Dr. Jaffar Albareeq</investigator_full_name>
    <investigator_title>Director of Research</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Airway Obstruction</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/NCT03752593
org study id: KHUH/Anesthesia
nct id: NCT03752593
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
The aim of our study is to identify the incidence of difficult endotracheal intubation in
      patients with normal BMI undergoing surgery under general anaesthesia in our hospital and
      compare it to that of obese patients.
observational model: Cohort
time perspective: Prospective
measure: Assessment of difficulty in airway management
time frame: two years
description: Assessment of Cormack Lehanne grading (intubation difficulty scale) IDS.
arm group label: Obese
description: Patients with a BMI of greater than 30 who are presenting to the hospital for any surgical procedure requiring general anesthesia
arm group label: Non-Obese
description: Patients with a BMI of less than 30 who are presenting to the hospital for any surgical procedure requiring general anesthesia
intervention type: Other
intervention name: ET Tube
description: Patients with a BMI of greater than 30 or less than who are presenting to the hospital for any surgical procedure requiring general anesthesia
arm group label: Non-Obese
arm group label: Obese
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Bahrain
citation: Murphy C, Wong DT. Airway management and oxygenation in obese patients. Can J Anaesth. 2013 Sep;60(9):929-45. doi: 10.1007/s12630-013-9991-x. Epub 2013 Jul 9.
PMID: 23836064
citation: Lundstrom LH. Detection of risk factors for difficult tracheal intubation. Dan Med J. 2012 Apr;59(4):B4431.
PMID: 22459727
citation: Shiga T, Wajima Z, Inoue T, Sakamoto A. Predicting difficult intubation in apparently normal patients: a meta-analysis of bedside screening test performance. Anesthesiology. 2005 Aug;103(2):429-37. doi: 10.1097/00000542-200508000-00027.
PMID: 16052126
citation: Lavi R, Segal D, Ziser A. Predicting difficult airways using the intubation difficulty scale: a study comparing obese and non-obese patients. J Clin Anesth. 2009 Jun;21(4):264-7. doi: 10.1016/j.jclinane.2008.08.021. Epub 2009 Jun 6.
PMID: 19502026
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: De Jong A, Molinari N, Pouzeratte Y, Verzilli D, Chanques G, Jung B, Futier E, Perrigault PF, Colson P, Capdevila X, Jaber S. Difficult intubation in obese patients: incidence, risk factors, and complications in the operating theatre and in intensive care units. Br J Anaesth. 2015 Feb;114(2):297-306. doi: 10.1093/bja/aeu373. Epub 2014 Nov 27.
PMID: 25431308
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: Hashim MM, Ismail MA, Esmat AM, Adeel S. Difficult tracheal intubation in bariatric surgery patients, a myth or reality? Br J Anaesth. 2016 Apr;116(4):557-8. doi: 10.1093/bja/aew039. No abstract available.
PMID: 26994235
citation: Karkouti K, Rose DK, Wigglesworth D, Cohen MM. Predicting difficult intubation: a multivariable analysis. Can J Anaesth. 2000 Aug;47(8):730-9. doi: 10.1007/BF03019474.
PMID: 10958088
citation: Brodsky JB, Lemmens HJ, Brock-Utne JG, Vierra M, Saidman LJ. Morbid obesity and tracheal intubation. Anesth Analg. 2002 Mar;94(3):732-6; table of contents. doi: 10.1097/00000539-200203000-00047.
PMID: 11867407
citation: Bond A. Obesity and difficult intubation. Anaesth Intensive Care. 1993 Dec;21(6):828-30. doi: 10.1177/0310057X9302100614. No abstract available.
PMID: 8122742
citation: Benumof JL. Management of the difficult adult airway. With special emphasis on awake tracheal intubation. Anesthesiology. 1991 Dec;75(6):1087-110. doi: 10.1097/00000542-199112000-00021. Erratum In: Anesthesiology 1993 Jan;78(1):224.
PMID: 1824555
citation: Cormack RS, Lehane J. Difficult tracheal intubation in obstetrics. Anaesthesia. 1984 Nov;39(11):1105-11.
PMID: 6507827
responsible party type: Principal Investigator
investigator affiliation: King Hamad University Hospital, Bahrain
investigator full name: Dr. Jaffar Albareeq
investigator title: Director of Research
mesh term: Airway Obstruction