NCT04477148

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
149

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 26, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2015

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

July 14, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 20, 2020

Completed
Last Updated

July 20, 2020

Status Verified

July 1, 2020

Enrollment Period

10 months

First QC Date

July 14, 2020

Last Update Submit

July 17, 2020

Conditions

Keywords

Intubationobesitydisposable blade

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 minutes after anesthesia induction

Study Arms (3)

Metallic Reusable(MR)

ACTIVE COMPARATOR

Patients in this group were intubated with reusable metallic blades

Device: endotracheal intubation

Metallic Disposable(MD)

ACTIVE COMPARATOR

Patients in this group were intubated with disposable metallic blades

Device: endotracheal intubation

Plastic Disposable(PD)

ACTIVE COMPARATOR

Patients in this group were intubated with disposable plastic blades

Device: endotracheal intubation

Interventions

patients were intubated with 3 different blades

Metallic Disposable(MD)Metallic Reusable(MR)Plastic Disposable(PD)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • morbidly obese patients with 18-60 years age

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obesity, MorbidObesity

Interventions

Intubation, Intratracheal

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsIntubationInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2020

First Posted

July 20, 2020

Study Start

June 26, 2014

Primary Completion

April 26, 2015

Study Completion

June 26, 2015

Last Updated

July 20, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share