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

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ClinicalTrials.gov Identifier: NCT03589638
Recruitment Status : Completed
First Posted : July 18, 2018
Last Update Posted : July 22, 2021
Sponsor:
Information provided by (Responsible Party):
Ahmet Selim Ozkan, Inonu University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Anesthesiology Devices Associated With Adverse Incidents Intraocular Pressure Device: Direct laryngoscope Device: C-MAC videolaryngoscope Device: McGrath videolaryngoscope Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, Randomized, double blind Clinical Trial
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effects of C-MAC Videolaryngoscope, McGRATH Videolaryngoscope and Macintosh Direct Laryngoscope on Intraocular Pressure and Hemodynamics; a Randomized, Double-blind Clinical Trial
Actual Study Start Date : June 20, 2018
Actual Primary Completion Date : August 8, 2018
Actual Study Completion Date : August 8, 2018
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. intraocular pressure [ Time Frame: From beginning of Anesthesia to 10th minute of surgery ]
    The relevant values will be measured in the determined time.


Secondary Outcome Measures :
  1. mean arterial pressure [ Time Frame: From beginning of Anesthesia to 10th minute of surgery ]
    The relevant values will be measured in the determined time.

  2. systolic arterial pressure [ Time Frame: From beginning of Anesthesia to 10th minute of surgery ]
    The relevant values will be measured in the determined time.

  3. diastolic arterial pressure [ Time Frame: From beginning of Anesthesia to 10th minute of surgery ]
    The relevant values will be measured in the determined time.

  4. heart rate [ Time Frame: From beginning of Anesthesia to 10th minute of surgery ]
    The relevant values will be measured in the determined time.

  5. peripheral oxygen saturation [ Time Frame: From beginning of Anesthesia to 10th minute of surgery ]
    The relevant values will be measured in the determined time.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   18-65 years
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT03589638


Locations
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Turkey
Inonu University Medical Faculty
Malatya, Turkey, 44090
Sponsors and Collaborators
Inonu University
Investigators
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Principal Investigator: Ahmet Selim Ozkan, MD İnönü Üniversitesi Tıp Fakültesi
More Information
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Responsible Party: Ahmet Selim Ozkan, Department of anesthesia, Inonu University
ClinicalTrials.gov Identifier: NCT03589638    
Other Study ID Numbers: Asozkan 6
First Posted: July 18, 2018    Key Record Dates
Last Update Posted: July 22, 2021
Last Verified: July 2021
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 Ahmet Selim Ozkan, Inonu University:
tracheal intubation
videolaryngoscopy
hemodynamics
intraocular pressure