Intraocular PressureNCT03003585
Effects of Direct Laryngoscopic and Fiberoptic Intubation on Intraocular Pressure
A study testing Direct laryngoscope and Fiberoptic bronchoscope in people with Intraocular Pressure and Intubation Complication, run by Inonu University.
Trial summary
In this study, the investigators aimed to compare the effects of direct laryngoscopic and fiberoptic endotracheal intubation on intraocular pressure. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Intraocular Pressure, Intubation Complication
- What is being tested?
- Direct laryngoscope and Fiberoptic bronchoscope
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to 4 Apr 2017
- 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
- ASA (American Society of Anesthesiologist) Grade 1-2,
- Mallampati score 1 or 2,
- Age between 18 to 65
- Patient planned to undergo nonopthalmic surgery.
Who cannot join
- Patients with glaucoma, diabetes mellitus, cardiovascular and pulmonary diseases, ASA Grade III and IV, BMI more than 35,
- Patients with difficult intubation,
- Patients undergoing obstetrical surgery and propofol, fentanyl, rocuronium contraindicated.
About this study
Official title: Comparison of Effects of Direct Laryngoscopic and Fiberoptic Oral Endotracheal Intubation on Intraocular Pressure
In this study, the investigators aimed to compare the effects of direct laryngoscopic and fiberoptic endotracheal intubation on intraocular pressure.
Read the detailed description
Material and Method: Total of 54 American Society of Anesthesiologist Grade 1-2, Mallampati score 1 or 2, age between 18 to 65 patient planned to undergo nonopthalmic surgery will be included to study. Patients with glaucoma, diabetes mellitus, cardiovascular and pulmonary diseases, American Society of Anesthesiologist Grade III and IV, body mass index more than 35, difficult intubation, undergo obstetrical surgery and propofol, fentanyl, rocuronium contraindicated will be excluded from the study. Patients will be divided randomly into 2 groups as direct laryngoscopic and fiberoptic intubation group. Patients will be preoxygenated with %100 O2 for 3 minutes then anesthesia will be induced using propofol 2 mg / kg, fentanyl 1 mcg/kg, and rocuronium 0,5 mg / kg in both groups. After 3 minutes mask ventilation, patients will be intubated (women with No:7-7,5, men with No:8-8,5 intubation tube). Systolic blood pressure, diastolic blood pressure, mean arterial pressure, peripheral oxygen saturation,perfusion index will be recorded and intraocular pressure measured by ophthalmologist by tonopen device will be recorded pre-induction (basal), after induction, 1,2,3,5 minutes after intubation, respectively. Period between handling of laryngoscope or fiberoptic device after termination of mask ventilation and obtain end tidal CO2 will be accepted as application time and recorded. Study will be terminated after 5th minute values taken.
- Conditions
- Intraocular Pressure, Intubation Complication
- Being tested
- Direct laryngoscope, Fiberoptic bronchoscope
- Keywords
- intraocular pressure, direct laryngoscopy, fiberoptic bronchoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct laryngoscopeOther
This device is used in endotracheal intubation and tonopen device for measuring of intraocular pressure. The investigators want to evaluate which one is better.
Fiberoptic bronchoscopeOther
This device is used in endotracheal intubation and tonopen device for measuring of intraocular pressure. The investigators want to evaluate which one is better.
| Study group | Role | What they receive |
|---|---|---|
| Fiberoptic bronchoscopy | Active comparator | Evaluate the difference between the two groups about hemodynamic and intraocular pressure responses. Receives: Other: Fiberoptic bronchoscope |
| Direct laryngoscopy | Active comparator | Evaluate the difference between the two groups about hemodynamic and intraocular pressure responses. Receives: Other: Direct laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure
Measured: From Beginning of Anesthesia induction to 5th minutes of intubation
Heart rate
Measured: From Beginning of Anesthesia induction to 5th minutes of intubation
Adverse events
Measured: within the first 24 hour after surgery
Intraocular pressure
Measured: From Beginning of Anesthesia induction to 5th minutes of intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionFeb 2017
- Study completion4 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraocular PressureStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Selim Ozkan, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03003585
- Sponsor's protocol ID
- Asozkan-2
- Status last verified
- Apr 2017
- First submitted
- 22 Dec 2016
- Last updated
- 5 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effects of Direct Laryngoscopic and Fiberoptic Oral Endotracheal Intubation on Intraocular Pressure
- ClinicalTrials.gov ID
- NCT03003585
- Acronym / sponsor ID
- Asozkan-2
- Conditions
- Intraocular Pressure, Intubation Complication
- Keywords
- intraocular pressure, direct laryngoscopy, fiberoptic bronchoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Feb 2017 (actual)
- Study completion
- 4 Apr 2017 (actual)
- First posted
- 28 Dec 2016 (estimated)
- 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, the investigators aimed to compare the effects of direct laryngoscopic and fiberoptic endotracheal intubation on intraocular pressure.
Detailed description
Material and Method: Total of 54 American Society of Anesthesiologist Grade 1-2, Mallampati score 1 or 2, age between 18 to 65 patient planned to undergo nonopthalmic surgery will be included to study. Patients with glaucoma, diabetes mellitus, cardiovascular and pulmonary diseases, American Society of Anesthesiologist Grade III and IV, body mass index more than 35, difficult intubation, undergo obstetrical surgery and propofol, fentanyl, rocuronium contraindicated will be excluded from the study. Patients will be divided randomly into 2 groups as direct laryngoscopic and fiberoptic intubation group. Patients will be preoxygenated with %100 O2 for 3 minutes then anesthesia will be induced using propofol 2 mg / kg, fentanyl 1 mcg/kg, and rocuronium 0,5 mg / kg in both groups. After 3 minutes mask ventilation, patients will be intubated (women with No:7-7,5, men with No:8-8,5 intubation tube). Systolic blood pressure, diastolic blood pressure, mean arterial pressure, peripheral oxygen saturation,perfusion index will be recorded and intraocular pressure measured by ophthalmologist by tonopen device will be recorded pre-induction (basal), after induction, 1,2,3,5 minutes after intubation, respectively. Period between handling of laryngoscope or fiberoptic device after termination of mask ventilation and obtain end tidal CO2 will be accepted as application time and recorded. Study will be terminated after 5th minute values taken.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fiberoptic bronchoscopy | Active comparator | Other: Fiberoptic bronchoscopeEvaluate the difference between the two groups about hemodynamic and intraocular pressure responses. |
| Direct laryngoscopy | Active comparator | Other: Direct laryngoscopeEvaluate the difference between the two groups about hemodynamic and intraocular pressure responses. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA (American Society of Anesthesiologist) Grade 1-2,
- Mallampati score 1 or 2,
- Age between 18 to 65
- Patient planned to undergo nonopthalmic surgery.
Key exclusion criteria (3 listed)
- Patients with glaucoma, diabetes mellitus, cardiovascular and pulmonary diseases, ASA Grade III and IV, BMI more than 35,
- Patients with difficult intubation,
- Patients undergoing obstetrical surgery and propofol, fentanyl, rocuronium contraindicated.
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 laryngoscopeThis device is used in endotracheal intubation and tonopen device for measuring of intraocular pressure. The investigators want to evaluate which one is better. | Other | Direct laryngoscopy |
| Fiberoptic bronchoscopeThis device is used in endotracheal intubation and tonopen device for measuring of intraocular pressure. The investigators want to evaluate which one is better. | Other | Fiberoptic bronchoscopy |
Primary outcome
Systolic blood pressure
Time frame: From Beginning of Anesthesia induction to 5th minutes of intubation
Heart rate
Time frame: From Beginning of Anesthesia induction to 5th minutes of intubation
Adverse events
Time frame: within the first 24 hour after surgery
Intraocular pressure
Time frame: From Beginning of Anesthesia induction to 5th minutes of intubation
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 5 Apr 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Direct laryngoscope and Fiberoptic bronchoscope in people with Intraocular Pressure and Intubation Complication, run by Inonu University.
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 4 inclusion and 3 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 5 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Systolic blood pressure (time frame: From Beginning of Anesthesia induction to 5th minutes of intubation). The study lists 4 primary outcomes in all. 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 5 Apr 2017.