Comparison Of Videolaryngoscopes In Double Lumen Tube (D&Xblade)

Comparison Of Storz C-Mac® D Blade Videolaryngoscope With McGrath® X3 Blade Videolaryngoscope In Double Lumen Tube Patients

Along with the technological advances in medicine, videolaryngoscope is the most commonly preferred technique for intubation with double lumen tube. The use of Storz C-MAC D Blade and McGrath MAC X3 Blade videolaryngoscope were compared in intubation of single lung ventilation patients who underwent chest surgery in terms of duration of intubation, hemodynamic response and intubation-induced complications.

Study Overview

• Status: Unknown
• Conditions: One-lung Ventilation; Videolaryngoscopy; Double Lumen Tube
• Intervention / Treatment: Device: C-MAC Videolaryngoscope D blade; Device: McGrath MAC Videolaryngoscope X3 blade

Detailed Description

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. 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 intubation such as double lumen tube, 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 with D blade and McGrath MAC videolaryngoscope with X3 blade in respect to duration of intubation, haemodynamic response, and adverse events associated with intubation of patients undergoing lung surgery.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Malatya, Turkey, 44310
    • Ahmet Selim Ozkan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• American Society of Anesthesiology score III,
• 18-65 years,
• BMI> 40
• Patients who was intubated with double lumen tube.

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: C-MAC Videolaryngoscope D blade; Patients was intubated with C-MAC videolaryngoscope D blade.	Device: C-MAC Videolaryngoscope D blade; C-MAC videolaryngoscope D blade An intubating device that is used for endotracheal intubation. Endotracheal intubation was applied by anesthesiologist with C-MAC videolaryngoscope.; Device: McGrath MAC Videolaryngoscope X3 blade; McGrath MAC videolaryngoscope X blade An intubating device that is used for endotracheal intubation. Endotracheal intubation was applied by anesthesiologist with McGrath MAC videolaryngoscope.
Active Comparator: McGrath MAC Videolaryngoscope X3 blade; Patients was intubated with McGrath MAC Videolaryngoscope X3 blade	Device: C-MAC Videolaryngoscope D blade; C-MAC videolaryngoscope D blade An intubating device that is used for endotracheal intubation. Endotracheal intubation was applied by anesthesiologist with C-MAC videolaryngoscope.; Device: McGrath MAC Videolaryngoscope X3 blade; McGrath MAC videolaryngoscope X blade An intubating device that is used for endotracheal intubation. Endotracheal intubation was applied by anesthesiologist with McGrath MAC videolaryngoscope.

What is the study measuring?

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	At beginning of Anesthesia induction, 1st, 2nd, 3th and 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

Collaborators and Investigators

• Sponsor: Inonu University
• Investigators: Study Director: Ahmet Selim Ozkan, Inonu University Medical Faculty

Study record dates

Study Major Dates

• Study Start (Anticipated): February 15, 2019
• Primary Completion (Anticipated): March 30, 2019
• Study Completion (Anticipated): April 10, 2019

Study Registration Dates

• First Submitted: January 30, 2019
• First Submitted That Met QC Criteria: January 30, 2019
• First Posted (Actual): February 1, 2019

Study Record Updates

• Last Update Posted (Actual): February 5, 2019
• Last Update Submitted That Met QC Criteria: February 1, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Videolaryngoscopy; One-lung ventilation; Double lumen tube
• Additional Relevant MeSH Terms: Dermatologic Agents; Keratolytic Agents; Pyrithione zinc
• Other Study ID Numbers: Asozkan 4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No