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

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ClinicalTrials.gov Identifier: NCT03759990
Recruitment Status : Completed
First Posted : November 30, 2018
Last Update Posted : December 18, 2018
Sponsor:
Information provided by (Responsible Party):
Zehra Ipek ARSLAN, Kocaeli University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity, Morbid Device: lean Device: obese Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: A Comparison of Morbidly Obese and Lean
Actual Study Start Date : December 1, 2018
Actual Primary Completion Date : December 1, 2018
Actual Study Completion Date : December 1, 2018

Arm Intervention/treatment
Active Comparator: insertion time Device: lean
Videolaryngoscope used in intubation

Device: obese
Videolaryngoscope used in intubation

Active Comparator: intubation time Device: lean
Videolaryngoscope used in intubation

Device: obese
Videolaryngoscope used in intubation




Primary Outcome Measures :
  1. intubation time [ Time Frame: 2 months ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: > 18 age <65 age

  • bmı 35

    • undergoing elective surgery requiring endotracheal intubation

Exclusion Criteria: -pregnant

  • <18 and >65 years of age
  • bmı<35
  • upper respiratory tract infection past ten days

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03759990


Locations
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Turkey
Kocaeli University School of Medicine
Kocaeli, Turkey, 41900
Kocaeli University Medical Faculty
Kocaeli, Turkey
Sponsors and Collaborators
Kocaeli University

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Responsible Party: Zehra Ipek ARSLAN, Associate Professor, Kocaeli University
ClinicalTrials.gov Identifier: NCT03759990     History of Changes
Other Study ID Numbers: KOU-KAEK 2018 - 202
First Posted: November 30, 2018    Key Record Dates
Last Update Posted: December 18, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zehra Ipek ARSLAN, Kocaeli University:
videolaryngoscope
Airtraq
McGrath MAC
Morbid obesity
intubation
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms