Tracheal Intubation in Morbidly Obese (BMI>35) and in Lean (BMI<30) Patients Using McGrath MAC X-Blade

NCT ID: NCT03759990

Last Updated: 2020-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-01

Study Completion Date

2018-12-01

Brief Summary

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80 lean (BMI\<35) and morbidly obese (BMI\>35) patients undergoing elective surgery were enrolled in this prospective ransomİzed study were intubated using McGrath MAC X-Blade. The demographic and airway variables of patients and insertion and intubation times with these dievices, need for optimisation maneuvers, hemodynamic changes and minör postoperative complications were recorded.

Detailed Description

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80 lean (BMI\<35) and morbidly obese (BMI\>35) patients undergoing elective surgery were enrolled in this prospective ransomİzed study were intubated using McGrath MAC X-Blade. The demographic and airway variables of patients were recorded. Airway management variables Cormack-Lehan grades, insertion and intubation times, need for optimization maneuvers ( cricoid pressure, re-inserting, drawback) , hemodynamic changes in heart rate , blood pressure and minor postoperative complications such as sore throat, dysphasia, hoarseness were recorded.

Conditions

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Obesity, Morbid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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insertion time

Group Type ACTIVE_COMPARATOR

lean

Intervention Type DEVICE

Videolaryngoscope used in intubation

obese

Intervention Type DEVICE

Videolaryngoscope used in intubation

intubation time

Group Type ACTIVE_COMPARATOR

lean

Intervention Type DEVICE

Videolaryngoscope used in intubation

obese

Intervention Type DEVICE

Videolaryngoscope used in intubation

Interventions

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lean

Videolaryngoscope used in intubation

Intervention Type DEVICE

obese

Videolaryngoscope used in intubation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* bmı 35

* undergoing elective surgery requiring endotracheal intubation

Exclusion Criteria

* \<18 and \>65 years of age
* bmı\<35
* upper respiratory tract infection past ten days
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kocaeli University

OTHER

Sponsor Role lead

Responsible Party

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Zehra Ipek ARSLAN

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kocaeli University School of Medicine

Kocaeli, , Turkey (Türkiye)

Site Status

Kocaeli University Medical Faculty

Kocaeli, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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KOU-KAEK 2018 - 202

Identifier Type: -

Identifier Source: org_study_id

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