search
Back to results

Comparison of Intubation Success Rates of 3 Different Laryngoscope Blade Types in Morbidly Obese Patients

Primary Purpose

Intubation;Difficult, Morbid Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
endotracheal intubation
Sponsored by
Turkish Society of Anesthesiology and Reanimation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Intubation;Difficult focused on measuring Intubation, obesity, disposable blade

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • morbidly obese patients with 18-60 years age

Exclusion Criteria:

  • less than 3 cm of mouth opening
  • airway pathology
  • restricted head and neck movement
  • expected difficult airway
  • sore throat
  • upper airway infection

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Metallic Reusable(MR)

    Metallic Disposable(MD)

    Plastic Disposable(PD)

    Arm Description

    Patients in this group were intubated with reusable metallic blades

    Patients in this group were intubated with disposable metallic blades

    Patients in this group were intubated with disposable plastic blades

    Outcomes

    Primary Outcome Measures

    comparison success rate of intubation in three different blades
    The investigators compared reusable metal, single-use metal and single-use plastic blades for their effectiveness in laryngoscopy and intubation in morbid obese patients.

    Secondary Outcome Measures

    Full Information

    First Posted
    July 14, 2020
    Last Updated
    July 17, 2020
    Sponsor
    Turkish Society of Anesthesiology and Reanimation
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04477148
    Brief Title
    Comparison of Intubation Success Rates of 3 Different Laryngoscope Blade Types in Morbidly Obese Patients
    Official Title
    Comparison of Intubation Success Rates of Metallic Reusable Laryngoscope Blades and Metallic/Plastic Laryngoscope Blades in Morbidly Obese Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    June 26, 2014 (Actual)
    Primary Completion Date
    April 26, 2015 (Actual)
    Study Completion Date
    June 26, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Turkish Society of Anesthesiology and Reanimation

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Intubation;Difficult, Morbid Obesity
    Keywords
    Intubation, obesity, disposable blade

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    149 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Metallic Reusable(MR)
    Arm Type
    Active Comparator
    Arm Description
    Patients in this group were intubated with reusable metallic blades
    Arm Title
    Metallic Disposable(MD)
    Arm Type
    Active Comparator
    Arm Description
    Patients in this group were intubated with disposable metallic blades
    Arm Title
    Plastic Disposable(PD)
    Arm Type
    Active Comparator
    Arm Description
    Patients in this group were intubated with disposable plastic blades
    Intervention Type
    Device
    Intervention Name(s)
    endotracheal intubation
    Intervention Description
    patients were intubated with 3 different blades
    Primary Outcome Measure Information:
    Title
    comparison success rate of intubation in three different blades
    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.
    Time Frame
    3 minutes after anesthesia induction

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: morbidly obese patients with 18-60 years age Exclusion Criteria: less than 3 cm of mouth opening airway pathology restricted head and neck movement expected difficult airway sore throat upper airway infection

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Comparison of Intubation Success Rates of 3 Different Laryngoscope Blade Types in Morbidly Obese Patients

    We'll reach out to this number within 24 hrs