Anesthesiology Devices Associated With Adverse IncidentsNCT03589638
Effects of C-MAC Videolaryngoscope, McGRATH Videolaryngoscope and Macintosh Direct Laryngoscope on Intraocular Pressure and Hemodynamics
A study testing Direct laryngoscope, C-MAC videolaryngoscope and McGrath videolaryngoscope in people with Anesthesiology Devices Associated With Adverse Incidents and Intraocular Pressure, run by Inonu University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anesthesiology Devices Associated With Adverse Incidents, Intraocular Pressure
- What is being tested?
- Direct laryngoscope, C-MAC videolaryngoscope and McGrath videolaryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jun 2018to 8 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologist Score 1-2
- Mallampati 1 ve 2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Inonu University Medical Faculty
Malatya, 44090
About this study
Official title: 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.
Read the 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.
- Being tested
- Direct laryngoscope, C-MAC videolaryngoscope, McGrath videolaryngoscope
- Keywords
- tracheal intubation, videolaryngoscopy, hemodynamics, intraocular pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 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.
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.
| Study group | Role | What they receive |
|---|---|---|
| direct laryngoscope | Active comparator | Endotracheal intubation was applied by anesthesiologist with direct laryngoscope. Receives: Device: Direct laryngoscope; Device: C-MAC videolaryngoscope; Device: McGrath videolaryngoscope |
| C-MAC videolaryngoscope | Active comparator | Endotracheal intubation was applied by anesthesiologist with C-MAC videolaryngoscope. Receives: Device: Direct laryngoscope; Device: C-MAC videolaryngoscope; Device: McGrath videolaryngoscope |
| McGrath videolaryngoscope | Active comparator | Endotracheal intubation was applied by anesthesiologist with McGrath videolaryngoscope. Receives: Device: Direct laryngoscope; Device: C-MAC videolaryngoscope; Device: McGrath videolaryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraocular pressure
The relevant values will be measured in the determined time.
Measured: From beginning of Anesthesia to 10th minute of surgery
Secondary outcomes (5)
mean arterial pressure
The relevant values will be measured in the determined time.
Measured: From beginning of Anesthesia to 10th minute of surgery
systolic arterial pressure
The relevant values will be measured in the determined time.
Measured: From beginning of Anesthesia to 10th minute of surgery
diastolic arterial pressure
The relevant values will be measured in the determined time.
Measured: From beginning of Anesthesia to 10th minute of surgery
heart rate
The relevant values will be measured in the determined time.
Measured: From beginning of Anesthesia to 10th minute of surgery
peripheral oxygen saturation
The relevant values will be measured in the determined time.
Measured: From beginning of Anesthesia to 10th minute of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2018
- Study start20 Jun 2018
- Primary completion8 Aug 2018
- Study completion8 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesiology Devices Associated With Adverse IncidentsStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, Randomized, double blind Clinical Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Selim Ozkan, Inonu University
- Investigators
- Ahmet Selim Ozkan, MD, Principal investigator, İnönü Üniversitesi Tıp Fakültesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03589638
- Sponsor's protocol ID
- Asozkan 6
- Status last verified
- Jul 2021
- First submitted
- 18 Jun 2018
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of C-MAC Videolaryngoscope, McGRATH Videolaryngoscope and Macintosh Direct Laryngoscope on Intraocular Pressure and Hemodynamics; a Randomized, Double-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT03589638
- Acronym / sponsor ID
- Asozkan 6
- Keywords
- tracheal intubation, videolaryngoscopy, hemodynamics, intraocular pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 20 Jun 2018 (actual)
- Primary completion
- 8 Aug 2018 (actual)
- Study completion
- 8 Aug 2018 (actual)
- First posted
- 18 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Prospective, Randomized, double blind Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| direct laryngoscope | Active comparator | Device: Direct laryngoscope, Device: C-MAC videolaryngoscope, Device: McGrath videolaryngoscopeEndotracheal intubation was applied by anesthesiologist with direct laryngoscope. |
| C-MAC videolaryngoscope | Active comparator | Device: Direct laryngoscope, Device: C-MAC videolaryngoscope, Device: McGrath videolaryngoscopeEndotracheal intubation was applied by anesthesiologist with C-MAC videolaryngoscope. |
| McGrath videolaryngoscope | Active comparator | Device: Direct laryngoscope, Device: C-MAC videolaryngoscope, Device: McGrath videolaryngoscopeEndotracheal intubation was applied by anesthesiologist with McGrath videolaryngoscope. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologist Score 1-2
- Mallampati 1 ve 2
Key exclusion criteria (8 listed)
- Glaucoma,
- Diabetes mellitus
- Cardiovascular and pulmonary disease
- American Society of Anesthesiologist Score III-IV
- Bdoy mass index greater than 35
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Direct laryngoscopeEndotracheal 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, McGrath videolaryngoscope, direct laryngoscope |
| C-MAC videolaryngoscopeEndotracheal 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, McGrath videolaryngoscope, direct laryngoscope |
| McGrath videolaryngoscopeEndotracheal 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, McGrath videolaryngoscope, direct laryngoscope |
Primary outcome
intraocular pressure
Time frame: From beginning of Anesthesia to 10th minute of surgery
The relevant values will be measured in the determined time.
5 secondary outcomes
mean arterial pressure
Time frame: From beginning of Anesthesia to 10th minute of surgery
systolic arterial pressure
Time frame: From beginning of Anesthesia to 10th minute of surgery
diastolic arterial pressure
Time frame: From beginning of Anesthesia to 10th minute of surgery
heart rate
Time frame: From beginning of Anesthesia to 10th minute of surgery
peripheral oxygen saturation
Time frame: From beginning of Anesthesia to 10th minute of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmet Selim Ozkan, MD principal investigator
İnönü Üniversitesi Tıp Fakültesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct laryngoscope, C-MAC videolaryngoscope and McGrath videolaryngoscope in people with Anesthesiology Devices Associated With Adverse Incidents and Intraocular Pressure, run by Inonu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intraocular pressure (time frame: From beginning of Anesthesia to 10th minute of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2021.