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
About this trial
This is an interventional supportive care trial for Intubation;Difficult focused on measuring Intubation, obesity, disposable blade
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
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
NCT ID
NCT04477148
First Posted
July 14, 2020
Last Updated
July 17, 2020
Sponsor
Turkish Society of Anesthesiology and Reanimation
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
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