<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/NCT04477148</url>
  </required_header>
  <id_info>
    <org_study_id>Uludaguni</org_study_id>
    <nct_id>NCT04477148</nct_id>
  </id_info>
  <brief_title>Comparison of Intubation Success Rates of 3 Different Laryngoscope Blade Types in Morbidly Obese Patients</brief_title>
  <official_title>Comparison of Intubation Success Rates of Metallic Reusable Laryngoscope Blades and Metallic/Plastic Laryngoscope Blades in Morbidly Obese Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Turkish Society of Anesthesiology and Reanimation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Turkish Society of Anesthesiology and Reanimation</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>
      Reusable laryngoscope blades, which are the most commonly used devices for airway management,&#xD;
      have been reported to be frequently contaminated and a possible source of infection. Although&#xD;
      disposable laryngoscope blades are recommended to reduce the risk of infection, there are&#xD;
      studies suggesting increased failed intubation attempt rates.&#xD;
&#xD;
      The major cause of anesthesia-related mortality and morbidity is the failure of airway&#xD;
      management. The incidence of difficult airway is reported to be 1-4% in normal population&#xD;
      while it ranges up to 12-20% in obese patients. Following the introduction of disposable&#xD;
      blades and considering the increased rate of failed intubation in obese patients with these&#xD;
      devices, the investigators aimed to make a comparison of successful intubation rates of&#xD;
      plastic and metallic disposable blades in morbidly obese patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Successful airway management is the first and most important step of patient safety in&#xD;
      anesthesia practice, and most common reason of morbidity and mortality related to anesthesia&#xD;
      is failure to provide optimum airway safety.&#xD;
&#xD;
      Intubation helps the anesthesiologist have complete control over airway by keeping airway&#xD;
      open, facilitating control over ventilation, reducing the risk of aspiration and providing&#xD;
      safe airway during resuscitation, and laryngoscopes are most commonly used tools for this&#xD;
      purpose. Laryngoscope are comprised of a handle and a blade (also contains light source)&#xD;
      which are mostly reusable. But these parts are easily contaminated during intubation,&#xD;
      creating susceptibility to infection. Some studies report that even handles have a chance of&#xD;
      50% to be contaminated with blood. Insufficiently disinfected blades are also a major source&#xD;
      of infection. Laryngoscopes contact with non-intact mucous membranes and blood frequently,&#xD;
      thus play an important role in cross contamination. Abramson et al. reported that 1/3 of&#xD;
      reusable laryngoscope blades are contaminated with bacteria after multiple uses. Concerns&#xD;
      about hygiene and risk of infection (including prion infections) caused many health&#xD;
      professionals tend towards use of disposable medical devices. Following their introduction,&#xD;
      single use laryngoscope blades have been subject to many studies, and many opinions were&#xD;
      discussed in different platforms. In studies in which intubation success rates of metallic&#xD;
      reusable, metallic disposable and plastic disposable blades were compared, while some have&#xD;
      demonstratedd their success rates to be identical, others concluded that plastic disposable&#xD;
      blades were ineffective compared to two other.&#xD;
&#xD;
      Laryngoscopy and endotracheal intubation may not be easily performed in every case. Airway&#xD;
      management and endotracheal intubation are easier in non-obese patients compared to obese&#xD;
      patients. Short and relatively immobile neck, narrow interincisor distance, hypertrophic&#xD;
      tonsillae, uvula and adenoids in obese patients makes intubation more difficult in these&#xD;
      patients. Additionally, loss of muscle tonus causes tongue to obstruct airway and epiglottis&#xD;
      to touch posterior wall of pharynx, thus obstructing airway further.&#xD;
&#xD;
      The investigators couldn't find any study conducted on obese patients evaluating success&#xD;
      rates for intubation of metallic reusable, metallic disposable and plastic disposable blades&#xD;
      in the literature. In this study, they aimed to compare intubation success rates of metallic&#xD;
      reusable, metallic disposable and plastic disposable blades in intubation of obese patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 26, 2014</start_date>
  <completion_date type="Actual">June 26, 2015</completion_date>
  <primary_completion_date type="Actual">April 26, 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>comparison success rate of intubation in three different blades</measure>
    <time_frame>3 minutes after anesthesia induction</time_frame>
    <description>The investigators compared reusable metal, single-use metal and single-use plastic blades for their effectiveness in laryngoscopy and intubation in morbid obese patients.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">149</enrollment>
  <condition>Intubation;Difficult</condition>
  <condition>Morbid Obesity</condition>
  <arm_group>
    <arm_group_label>Metallic Reusable(MR)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in this group were intubated with reusable metallic blades</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Metallic Disposable(MD)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in this group were intubated with disposable metallic blades</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Plastic Disposable(PD)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in this group were intubated with disposable plastic blades</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>endotracheal intubation</intervention_name>
    <description>patients were intubated with 3 different blades</description>
    <arm_group_label>Metallic Disposable(MD)</arm_group_label>
    <arm_group_label>Metallic Reusable(MR)</arm_group_label>
    <arm_group_label>Plastic Disposable(PD)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  morbidly obese patients with 18-60 years age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  less than 3 cm of mouth opening&#xD;
&#xD;
          -  airway pathology&#xD;
&#xD;
          -  restricted head and neck movement&#xD;
&#xD;
          -  expected difficult airway&#xD;
&#xD;
          -  sore throat&#xD;
&#xD;
          -  upper airway infection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 14, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>July 17, 2020</last_update_submitted>
  <last_update_submitted_qc>July 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Intubation</keyword>
  <keyword>obesity</keyword>
  <keyword>disposable blade</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity, Morbid</mesh_term>
  </condition_browse>
  <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/NCT04477148
org study id: Uludaguni
nct id: NCT04477148
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Reusable laryngoscope blades, which are the most commonly used devices for airway management,
      have been reported to be frequently contaminated and a possible source of infection. Although
      disposable laryngoscope blades are recommended to reduce the risk of infection, there are
      studies suggesting increased failed intubation attempt rates.

      The major cause of anesthesia-related mortality and morbidity is the failure of airway
      management. The incidence of difficult airway is reported to be 1-4% in normal population
      while it ranges up to 12-20% in obese patients. Following the introduction of disposable
      blades and considering the increased rate of failed intubation in obese patients with these
      devices, the investigators aimed to make a comparison of successful intubation rates of
      plastic and metallic disposable blades in morbidly obese patients
Successful airway management is the first and most important step of patient safety in
      anesthesia practice, and most common reason of morbidity and mortality related to anesthesia
      is failure to provide optimum airway safety.

      Intubation helps the anesthesiologist have complete control over airway by keeping airway
      open, facilitating control over ventilation, reducing the risk of aspiration and providing
      safe airway during resuscitation, and laryngoscopes are most commonly used tools for this
      purpose. Laryngoscope are comprised of a handle and a blade (also contains light source)
      which are mostly reusable. But these parts are easily contaminated during intubation,
      creating susceptibility to infection. Some studies report that even handles have a chance of
      50% to be contaminated with blood. Insufficiently disinfected blades are also a major source
      of infection. Laryngoscopes contact with non-intact mucous membranes and blood frequently,
      thus play an important role in cross contamination. Abramson et al. reported that 1/3 of
      reusable laryngoscope blades are contaminated with bacteria after multiple uses. Concerns
      about hygiene and risk of infection (including prion infections) caused many health
      professionals tend towards use of disposable medical devices. Following their introduction,
      single use laryngoscope blades have been subject to many studies, and many opinions were
      discussed in different platforms. In studies in which intubation success rates of metallic
      reusable, metallic disposable and plastic disposable blades were compared, while some have
      demonstratedd their success rates to be identical, others concluded that plastic disposable
      blades were ineffective compared to two other.

      Laryngoscopy and endotracheal intubation may not be easily performed in every case. Airway
      management and endotracheal intubation are easier in non-obese patients compared to obese
      patients. Short and relatively immobile neck, narrow interincisor distance, hypertrophic
      tonsillae, uvula and adenoids in obese patients makes intubation more difficult in these
      patients. Additionally, loss of muscle tonus causes tongue to obstruct airway and epiglottis
      to touch posterior wall of pharynx, thus obstructing airway further.

      The investigators couldn't find any study conducted on obese patients evaluating success
      rates for intubation of metallic reusable, metallic disposable and plastic disposable blades
      in the literature. In this study, they aimed to compare intubation success rates of metallic
      reusable, metallic disposable and plastic disposable blades in intubation of obese patients.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: comparison success rate of intubation in three different blades
time frame: 3 minutes after anesthesia induction
description: The investigators compared reusable metal, single-use metal and single-use plastic blades for their effectiveness in laryngoscopy and intubation in morbid obese patients.
arm group label: Metallic Reusable(MR)
arm group type: Active Comparator
description: Patients in this group were intubated with reusable metallic blades
arm group label: Metallic Disposable(MD)
arm group type: Active Comparator
description: Patients in this group were intubated with disposable metallic blades
arm group label: Plastic Disposable(PD)
arm group type: Active Comparator
description: Patients in this group were intubated with disposable plastic blades
intervention type: Device
intervention name: endotracheal intubation
description: patients were intubated with 3 different blades
arm group label: Metallic Disposable(MD)
arm group label: Metallic Reusable(MR)
arm group label: Plastic Disposable(PD)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Obesity, Morbid
sharing ipd: No