Intubation ComplicationPhase 4NCT02474394
Effects of Videolaryngoscope on Intraocular Pressure
A Phase 4 study testing Mcgrath and Macintosh in people with Intubation Complication, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).
Trial summary
This study is designed to compare the effects of the McGrath Series 5 video laryngoscope and Macintosh laryngoscope on intraocular pressure during laryngoscopy. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Intubation Complication
- What is being tested?
- Mcgrath and Macintosh
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2013to Jun 2015
- Phase
- Phase 4
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American society of anesthesiologist physical status I
- Non-ophthalmic elective surgery under general anesthesia
Who cannot join
- A history of pre-existing glaucoma or previous intraocular surgery
- Thyromental distance below 6cm
- Maximum mouth opening below 3cm
- Mallampati score of III or IV
- Pre-anesthetic intraocular pressure above 20 mmHg
- Number of intubation attempts more than 2
- Obstetric or laparoscopic surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpasa University Medical School
Tokat Province, 60100
About this study
Official title: The Comparison of the Effects of McGrath Video Laryngoscope and the Macintosh Laryngoscope on Intraocular Pressure: A Randomized Trial
This study is designed to compare the effects of the McGrath Series 5 video laryngoscope and Macintosh laryngoscope on intraocular pressure during laryngoscopy.
Read the detailed description
The stability of the intraocular pressure plays an important role during ophthalmic surgery. The systemic blood pressure, aqueous humor dynamics, choroidal blood volume, central venous pressure, extra-ocular muscle tone, and also conventional laryngoscopy affect the intraocular pressure.It was shown that the new devices for laryngoscopy, such as video laryngoscopes provide minimal hemodynamic changes when compared to direct laryngoscopes. However there is no current data about the effects of the intubation with McGrath videolaryngoscope on intraocular pressure. The main objective of this study to compare the effects of the McGrath Series 5 video laryngoscope and Macintosh laryngoscope on intraocular pressure during laryngoscopy.
- Conditions
- Intubation Complication
- Being tested
- Mcgrath, Macintosh
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
McgrathDevice
Also called videolaryngoscope
The patient will be intubated using McGrath series 5 video laryngoscope and the intraocular pressure of the patient will be evaluated with Tonopen XL tonometer
MacintoshDevice
Also called Conventional Laryngoscope
The patient will be intubated using Macintosh laryngoscope and the intraocular pressure of the patient will be evaluated with Tonopen XL tonometer
| Study group | Role | What they receive |
|---|---|---|
| Mcgrath | Active comparator | The endotracheal intubation will be provided using Mcgrath series 5 video laryngoscope Receives: Device: Mcgrath |
| Macintosh | Active comparator | The endotracheal incubation will be provided using macintosh laryngoscope Receives: Device: Macintosh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure
The intraocular pressure measurement will be performed using a Tono-Pen XL tonometer (Reichert Inc., USA) by an ophthalmologist who is blind to the intubation device used.
Measured: during laryngoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2015 (estimated)
- Study startFeb 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intubation ComplicationStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğba Karaman, Tokat Gaziosmanpasa University
- Investigators
- Tugba Karaman, M.D., Principal investigator, Gaziosmanpasa University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02474394
- Sponsor's protocol ID
- IOP-1
- Status last verified
- Jun 2015
- First submitted
- 15 Jun 2015
- Last updated
- 26 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of the Effects of McGrath Video Laryngoscope and the Macintosh Laryngoscope on Intraocular Pressure: A Randomized Trial
- ClinicalTrials.gov ID
- NCT02474394
- Acronym / sponsor ID
- IOP-1
- Conditions
- Intubation Complication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 17 Jun 2015 (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.
This study is designed to compare the effects of the McGrath Series 5 video laryngoscope and Macintosh laryngoscope on intraocular pressure during laryngoscopy.
Detailed description
The stability of the intraocular pressure plays an important role during ophthalmic surgery. The systemic blood pressure, aqueous humor dynamics, choroidal blood volume, central venous pressure, extra-ocular muscle tone, and also conventional laryngoscopy affect the intraocular pressure.It was shown that the new devices for laryngoscopy, such as video laryngoscopes provide minimal hemodynamic changes when compared to direct laryngoscopes. However there is no current data about the effects of the intubation with McGrath videolaryngoscope on intraocular pressure. The main objective of this study to compare the effects of the McGrath Series 5 video laryngoscope and Macintosh laryngoscope on intraocular pressure during laryngoscopy.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mcgrath | Active comparator | Device: McgrathThe endotracheal intubation will be provided using Mcgrath series 5 video laryngoscope |
| Macintosh | Active comparator | Device: MacintoshThe endotracheal incubation will be provided using macintosh laryngoscope |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American society of anesthesiologist physical status I
- Non-ophthalmic elective surgery under general anesthesia
Key exclusion criteria (7 listed)
- A history of pre-existing glaucoma or previous intraocular surgery
- Thyromental distance below 6cm
- Maximum mouth opening below 3cm
- Mallampati score of III or IV
- Pre-anesthetic intraocular pressure above 20 mmHg
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 |
|---|---|---|
| McgrathAlso: videolaryngoscopeThe patient will be intubated using McGrath series 5 video laryngoscope and the intraocular pressure of the patient will be evaluated with Tonopen XL tonometer | Device | Mcgrath |
| MacintoshAlso: Conventional LaryngoscopeThe patient will be intubated using Macintosh laryngoscope and the intraocular pressure of the patient will be evaluated with Tonopen XL tonometer | Device | Macintosh |
Primary outcome
Intraocular pressure
Time frame: during laryngoscopy
The intraocular pressure measurement will be performed using a Tono-Pen XL tonometer (Reichert Inc., USA) by an ophthalmologist who is blind to the intubation device used.
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 26 Jun 2015.
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Cardiovascular History and Hemodynamic Complications After Intubation in ICU
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Postoperative Pulmonary Complications After Use of Supraglottic Airway Devices and Neuromuscular Blockade
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Establish Whether Hyperangulated Videolaryngoscopy (HAVL) Can be Used to Facilitate Tracheal Intubation Effectively and Safely in Unselected Adult Patients; Describe the Population in Whom HAVL Fails to Facilitate Tracheal Intubation Successfully, Identifying Any Contributory Characteristics.
Intubation Skill, Intubation Complications
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.
Tugba Karaman, M.D. principal investigator
Gaziosmanpasa University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mcgrath and Macintosh in people with Intubation Complication, run by Tokat Gaziosmanpasa 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 7 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 26 Jun 2015. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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: during laryngoscopy). 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 26 Jun 2015.