NCT03589638

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

June 20, 2018

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 18, 2018

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2018

Completed
Last Updated

July 22, 2021

Status Verified

July 1, 2021

Enrollment Period

2 months

First QC Date

June 18, 2018

Last Update Submit

July 17, 2021

Conditions

Anesthesiology Devices Associated With Adverse IncidentsIntraocular Pressure

Keywords

tracheal intubationvideolaryngoscopyhemodynamicsintraocular pressure

Outcome Measures

Primary Outcomes (1)

  • intraocular pressure

    The relevant values will be measured in the determined time.

    From beginning of Anesthesia to 10th minute of surgery

Secondary Outcomes (5)

  • mean arterial pressure

    From beginning of Anesthesia to 10th minute of surgery

  • systolic arterial pressure

    From beginning of Anesthesia to 10th minute of surgery

  • diastolic arterial pressure

    From beginning of Anesthesia to 10th minute of surgery

  • heart rate

    From beginning of Anesthesia to 10th minute of surgery

  • peripheral oxygen saturation

    From beginning of Anesthesia to 10th minute of surgery

Study Arms (3)

direct laryngoscope

ACTIVE COMPARATOR

Endotracheal intubation was applied by anesthesiologist with direct laryngoscope.

Device: Direct laryngoscopeDevice: C-MAC videolaryngoscopeDevice: McGrath videolaryngoscope

C-MAC videolaryngoscope

ACTIVE COMPARATOR

Endotracheal intubation was applied by anesthesiologist with C-MAC videolaryngoscope.

Device: Direct laryngoscopeDevice: C-MAC videolaryngoscopeDevice: McGrath videolaryngoscope

McGrath videolaryngoscope

ACTIVE COMPARATOR

Endotracheal intubation was applied by anesthesiologist with McGrath videolaryngoscope.

Device: Direct laryngoscopeDevice: C-MAC videolaryngoscopeDevice: McGrath videolaryngoscope

Interventions

Direct laryngoscopeDEVICE

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.

C-MAC videolaryngoscopeMcGrath videolaryngoscopedirect laryngoscope
C-MAC videolaryngoscopeDEVICE

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.

C-MAC videolaryngoscopeMcGrath videolaryngoscopedirect laryngoscope
McGrath videolaryngoscopeDEVICE

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.

C-MAC videolaryngoscopeMcGrath videolaryngoscopedirect laryngoscope

Eligibility Criteria

Age18 Years - 65 Years
Sexall(Gender-based eligibility)
Gender Eligibility Details18-65 years
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiologist Score 1-2
  • Mallampati 1 ve 2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inonu University Medical Faculty

Malatya, 44090, Turkey (Türkiye)

Location

Study Officials

  • Ahmet Selim Ozkan, MD

    İnönü Üniversitesi Tıp Fakültesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective, Randomized, double blind Clinical Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of anesthesia

Study Record Dates

First Submitted

June 18, 2018

First Posted

July 18, 2018

Study Start

June 20, 2018

Primary Completion

August 8, 2018

Study Completion

August 8, 2018

Last Updated

July 22, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)