A Comparison of McGrath MAC Versus C-MAC Videolaryngoscopes in Morbidly Obese Patients

Study Overview
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Brief Summary
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Along with the technological advances in medicine, videolaryngoscope is the most commonly preferred technique for intubation of expected difficult airway management such as morbidly obese patients. In this prospective controlled clinical study, the purpose is to compare C-MAC videolaryngoscope and McGrath MAC videolaryngoscope in respect to duration of intubation, haemodynamic response, and complications related intubation of morbidly obese patients undergoing bariatric surgery.

Detailed Description
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It is very important for anesthesiologists to evaluate and make the airway safe in order to start and continue surgical operations. Endotracheal intubation has many important reasons such as ensuring airway control safely during surgical procedure, increasing the depth of anesthesia, need interventions for surgical or anesthetic complications, reduction of dead space, reduction of respiratory effort and prevention of aspiration risk. Mask ventilation and tracheal intubation in morbidly obese patients can be difficult with the anatomical changes caused by obesity. Reduced functional residual capacity in morbidly obese patients makes it difficult to maintain peripheral oxygen saturation at normal limits. Videolaryngoscope, developed in recent years and beginning to take place in the algorithms, facilitate difficult airway management and hence intubation. The use of videolaryngoscope in patients with difficult intubation such as morbid obesity, has been frequently reported in the literature. McGrath videolaryngoscope has a high-resolution video camera, a length-adjustable angle blade, and a light source at the tip of the blade. At the same time, the C-MAC videolaryngoscope is another advanced videolaryngoscope with a better quality video and camera system and improves the performance of videolaryngoscope with some technological changes. In this prospective controlled clinical study, the purpose is to compare C-MAC videolaryngoscope and McGrath MAC videolaryngoscope in respect to duration of intubation, haemodynamic response, and adverse events associated with intubation of morbidly obese patients undergoing bariatric surgery.

Official Title
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A Comparison of McGrath® MAC Versus C-MAC® Videolaryngoscopes in Morbidly Obese Patients Undergoing Bariatric Surgery: A Randomized, Controlled Clinical Trial

Conditions
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Difficult Intubation, Morbid Obesity, Videolaryngoscopy

Intervention / Treatment
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* Device: C-MAC videolaryngoscope
* Device: McGrath MAC videolaryngoscope


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiology score III, 18-65 years, BMI> 40 Exclusion Criteria: American Society of Anesthesiology IV, Under 18 years, Over 65 years, Under BMI<40 Obstetric patients, Uncontrolled cerebrovascular disease, Patients who refused written informed consent forms

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: C-MAC Videolaryngoscope<br>Morbidly obese patients intubated with C-MAC Videolaryngoscope | Device: C-MAC videolaryngoscope<br>* An intubating device that is used for endotracheal intubation. Endotracheal intubation was applied by anesthesiologist with C-MAC videolaryngoscope.<br>Device: McGrath MAC videolaryngoscope<br>* An intubating device that is used for endotracheal intubation. Endotracheal intubation was applied by anesthesiologist with McGrath MAC videolaryngoscope.<br>|
| Active Comparator: McGrath MAC Videolaryngoscope<br>Morbidly obese patients intubated with McGrath MAC Videolaryngoscope | Device: C-MAC videolaryngoscope<br>* An intubating device that is used for endotracheal intubation. Endotracheal intubation was applied by anesthesiologist with C-MAC videolaryngoscope.<br>Device: McGrath MAC videolaryngoscope<br>* An intubating device that is used for endotracheal intubation. Endotracheal intubation was applied by anesthesiologist with McGrath MAC videolaryngoscope.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to intubation | Time to intubation was defined as the time from when the anesthesiologist picked up the videolaryngoscope to when the anesthesiologist successfully placed the endotracheal tube through the vocal cords | From beginning of holding videolaryngoscope to seeing two meaningful end-tidal carbon dioxide levels up to 3 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Rate | Heart Rate | From beginning of Anesthesia induction to 5th minutes of intubation | 
| Mean Arterial Pressure | Mean Arterial Pressure | From beginning of Anesthesia induction to 5th minutes of intubation | 
| Adverse Events | Bleeding in the mouth, edema in the mouth, burst of intubation tube cuff, external laryngeal press, presence of head position change, laryngospasm, hypoxia, hoarseness, throat ache | During the first 24 hour postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Morbidly Obese, Difficult Airway Management, Videolaryngoscopy