Effects of C-MAC Videolaryngoscope, McGRATH Videolaryngoscope and Macintosh Direct Laryngoscope on Intraocular Pressure and Hemodynamics

Effects of C-MAC Videolaryngoscope, McGRATH Videolaryngoscope and Macintosh Direct Laryngoscope on Intraocular Pressure and Hemodynamics; a Randomized, Double-blind Clinical Trial

In this study, participants aimed to compare the effects of direct laryngoscopic endotracheal intubation and videolaryngoscopic intubation with C-MAC videolaryngoscope and McGrath videolaryngoscope on intraocular pressure and hemodynamics.

Study Overview

• Status: Completed
• Conditions: Intraocular Pressure; Anesthesiology Devices Associated With Adverse Incidents
• Intervention / Treatment: Device: Direct laryngoscope; Device: C-MAC videolaryngoscope; Device: McGrath videolaryngoscope

Detailed Description

The maintenance of airway opened is one of the main responsibility of the anesthetist. Intubation procedure during anesthesia application benefits such as airway opening, airway and breathing control, aspiration hazard, respiratory effort and dead space reduction, surgical comfort and airway control during resuscitation. Laryngoscopy and tracheal intubation increases in heart rate, blood pressure and the intraocular pressure. The sympathetic-adrenal activity caused by the stimulation of the laryngeal and tracheal tissues is responsible for these negative effects. Endotracheal intubation with videolaryngoscopy is an alternative method used in airway management. Laryngoscopy and tracheal intubation under general anesthesia and laryngeal mask and airway control techniques cause different hemodynamic and catecholamine levels.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Malatya, Turkey, 44090
    • Inonu University Medical Faculty

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 Anesthesiologist Score 1-2
• Mallampati 1 ve 2

Exclusion Criteria:

• Glaucoma,
• Diabetes mellitus
• Cardiovascular and pulmonary disease
• American Society of Anesthesiologist Score III-IV
• Bdoy mass index greater than 35
• Difficult intubation history
• Obstetric surgery
• Propofol, fentanyl, rocuronium contraindication

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: direct laryngoscope; Endotracheal intubation was applied by anesthesiologist with direct laryngoscope.	Device: Direct laryngoscope; Endotracheal intubation was applied by anesthesiologist wtih direct laryngoscope. SAP (systolic arterial pressure), DAP (diastolic arterial artery pressure), MAP (mean arterial pressure) were measured before and 5 minutes after intubation, , Heart rate (HR), SPO2 (oxygen saturation by pulse oximetry), PI (perfusion index), and intraocular pressure values measured by the eye clinician using the device.; Device: C-MAC videolaryngoscope; Endotracheal intubation was applied by anesthesiologist wtih direct laryngoscope. SAP (systolic arterial pressure), DAP (diastolic arterial artery pressure), MAP (mean arterial pressure) were measured before and 5 minutes after intubation, , Heart rate (HR), SPO2 (oxygen saturation by pulse oximetry), PI (perfusion index), and intraocular pressure values measured by the eye clinician using the device.; Device: McGrath videolaryngoscope; Endotracheal intubation was applied by anesthesiologist wtih direct laryngoscope. SAP (systolic arterial pressure), DAP (diastolic arterial artery pressure), MAP (mean arterial pressure) were measured before and 5 minutes after intubation, , Heart rate (HR), SPO2 (oxygen saturation by pulse oximetry), PI (perfusion index), and intraocular pressure values measured by the eye clinician using the device.
ACTIVE_COMPARATOR: C-MAC videolaryngoscope; Endotracheal intubation was applied by anesthesiologist with C-MAC videolaryngoscope.	Device: Direct laryngoscope; Endotracheal intubation was applied by anesthesiologist wtih direct laryngoscope. SAP (systolic arterial pressure), DAP (diastolic arterial artery pressure), MAP (mean arterial pressure) were measured before and 5 minutes after intubation, , Heart rate (HR), SPO2 (oxygen saturation by pulse oximetry), PI (perfusion index), and intraocular pressure values measured by the eye clinician using the device.; Device: C-MAC videolaryngoscope; Endotracheal intubation was applied by anesthesiologist wtih direct laryngoscope. SAP (systolic arterial pressure), DAP (diastolic arterial artery pressure), MAP (mean arterial pressure) were measured before and 5 minutes after intubation, , Heart rate (HR), SPO2 (oxygen saturation by pulse oximetry), PI (perfusion index), and intraocular pressure values measured by the eye clinician using the device.; Device: McGrath videolaryngoscope; Endotracheal intubation was applied by anesthesiologist wtih direct laryngoscope. SAP (systolic arterial pressure), DAP (diastolic arterial artery pressure), MAP (mean arterial pressure) were measured before and 5 minutes after intubation, , Heart rate (HR), SPO2 (oxygen saturation by pulse oximetry), PI (perfusion index), and intraocular pressure values measured by the eye clinician using the device.
ACTIVE_COMPARATOR: McGrath videolaryngoscope; Endotracheal intubation was applied by anesthesiologist with McGrath videolaryngoscope.	Device: Direct laryngoscope; Endotracheal intubation was applied by anesthesiologist wtih direct laryngoscope. SAP (systolic arterial pressure), DAP (diastolic arterial artery pressure), MAP (mean arterial pressure) were measured before and 5 minutes after intubation, , Heart rate (HR), SPO2 (oxygen saturation by pulse oximetry), PI (perfusion index), and intraocular pressure values measured by the eye clinician using the device.; Device: C-MAC videolaryngoscope; Endotracheal intubation was applied by anesthesiologist wtih direct laryngoscope. SAP (systolic arterial pressure), DAP (diastolic arterial artery pressure), MAP (mean arterial pressure) were measured before and 5 minutes after intubation, , Heart rate (HR), SPO2 (oxygen saturation by pulse oximetry), PI (perfusion index), and intraocular pressure values measured by the eye clinician using the device.; Device: McGrath videolaryngoscope; Endotracheal intubation was applied by anesthesiologist wtih direct laryngoscope. SAP (systolic arterial pressure), DAP (diastolic arterial artery pressure), MAP (mean arterial pressure) were measured before and 5 minutes after intubation, , Heart rate (HR), SPO2 (oxygen saturation by pulse oximetry), PI (perfusion index), and intraocular pressure values measured by the eye clinician using the device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intraocular pressure	The relevant values will be measured in the determined time.	From beginning of Anesthesia to 10th minute of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean arterial pressure	The relevant values will be measured in the determined time.	From beginning of Anesthesia to 10th minute of surgery
systolic arterial pressure	The relevant values will be measured in the determined time.	From beginning of Anesthesia to 10th minute of surgery
diastolic arterial pressure	The relevant values will be measured in the determined time.	From beginning of Anesthesia to 10th minute of surgery
heart rate	The relevant values will be measured in the determined time.	From beginning of Anesthesia to 10th minute of surgery
peripheral oxygen saturation	The relevant values will be measured in the determined time.	From beginning of Anesthesia to 10th minute of surgery

Collaborators and Investigators

• Sponsor: Inonu University
• Investigators: Principal Investigator: Ahmet Selim Ozkan, MD, İnönü Üniversitesi Tıp Fakültesi

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 20, 2018
• Primary Completion (ACTUAL): August 8, 2018
• Study Completion (ACTUAL): August 8, 2018

Study Registration Dates

• First Submitted: June 18, 2018
• First Submitted That Met QC Criteria: July 5, 2018
• First Posted (ACTUAL): July 18, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 22, 2021
• Last Update Submitted That Met QC Criteria: July 17, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: hemodynamics; intraocular pressure; tracheal intubation; videolaryngoscopy
• Other Study ID Numbers: Asozkan 6

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