AssessmentNCT03999866
Preoperative Assessment of Difficult Laryngoscopy Using Different Videolaryngoscopes
A study testing airtraq, mcgrath mac x-blade and storz c-mac in people with Assessment and Difficult Airway Intubation, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
preoperative assessment of difficult airways are the subject of debate. Now, measuring the thyromental distance or evaluating the mallampati score, mandible protrusion or body mass index still not 100% specifically say anything. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Assessment, Difficult Airway Intubation, Preoperative
- What is being tested?
- airtraq, mcgrath mac x-blade and storz c-mac
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2019to 1 Sep 2019
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- body mass index < 30
- no difficult airway history or predictor,
- no respiratory tract infections for ten days,
- Exclusion Criteria: BMI > 35, < 18 or > 60 years of age, expected difficult airway, pregnant
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kocaeli University School of Medicine
Kocaeli, 41900
About this study
Official title: Awake Airway Assessment With Video Laryngoscopes
preoperative assessment of difficult airways are the subject of debate. Now, measuring the thyromental distance or evaluating the mallampati score, mandible protrusion or body mass index still not 100% specifically say anything. We compare 4 different video laryngoscopes for preoperative assessment of difficult laryngoscopy.
Read the detailed description
preoperative assessment of difficult airways are the subject of debate. Now, measuring the thyromental distance or evaluating the mallampati score, mandible protrusion or body mass index still not 100% specifically say anything. all patients were pre oxygenated with 100% oxygen with nasal canulla during the whole procedure. We administered 0.07 mgr/kg remifentanil for minimum 3 minutes and continue this infusion during the procedure. The patients airway topicalized by 10% lidocaine spray. We enroll 20 patients undergoing elective surgery.
We compare 4 different video laryngoscopes for preoperative assessment of difficult laryngoscopy in the same patient. We evaluate the patient and the instructors satisfaction with the visual analogy scale and the visualization time. Demographic vary,ables and the airway characteristics of patients. We assess the cormack lehane view of these videolaryngoscopes with or without cricoid pressure. and the occurrence of gag reflex as well.
- Conditions
- Assessment, Difficult Airway Intubation, Preoperative
- Being tested
- airtraq, mcgrath mac x-blade, storz c-mac, storz d-blade
- Keywords
- airtraq, c-mac, d-blade, mcgarth mac x-blade, prediction, difficult airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
airtraqDevice
Also called videolaryngoscope
airtraq videolaryngoscope
mcgrath mac x-bladeDevice
Also called videolaryngoscope
mcgarth mac videolaryngoscope
storz c-macDevice
Also called videolaryngoscope
storz c-mac videolaryngoscope
storz d-bladeDevice
Also called videolaryngoscope
storz d-blade video laryngoscope
| Study group | Role | What they receive |
|---|---|---|
| satisfaction of instructor | Active comparator | visual analogy scale of the satisfaction of the instructor was recorded Receives: Device: airtraq; Device: mcgrath mac x-blade; Device: storz c-mac; Device: storz d-blade |
| satisfaction of the patient | Active comparator | visual analogy scale of the satisfaction of the patient was recorded Receives: Device: airtraq; Device: mcgrath mac x-blade; Device: storz c-mac; Device: storz d-blade |
| duration of view | Active comparator | duration of the visualization the vocal cords was recorded Receives: Device: airtraq; Device: mcgrath mac x-blade; Device: storz c-mac; Device: storz d-blade |
What is being measured
The primary outcome is the main question the study is designed to answer.
satisfaction of the instructor: visual analogy scale
visual analogy scale of the satisfaction
Measured: 2 minutes
Secondary outcomes (2)
satisfaction of the patient: visual analogy scale
visual analogy scale of the satisfaction
Measured: 2 minutes
duration view
time frame from the device enter the oral cavity till the vocal cords visualized
Measured: 10 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start1 Jul 2019
- Primary completion1 Sep 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AssessmentStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- We used these 4 video laryngoscopes ( c-mac, d-blade, macgrath mac x-blade and airtraq) on the same patient.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zehra Ipek ARSLAN, Kocaeli University
- Investigators
- Zehra I Arslan, Study chair, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03999866
- Sponsor's protocol ID
- KİA 2019/18
- Status last verified
- Oct 2019
- First submitted
- 25 Jun 2019
- Last updated
- 23 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- 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 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Awake Airway Assessment With Video Laryngoscopes
- ClinicalTrials.gov ID
- NCT03999866
- Acronym / sponsor ID
- KİA 2019/18
- Conditions
- Assessment, Difficult Airway Intubation, Preoperative
- Keywords
- airtraq, c-mac, d-blade, mcgarth mac x-blade, prediction, difficult airway
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 27 Jun 2019 (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.
preoperative assessment of difficult airways are the subject of debate. Now, measuring the thyromental distance or evaluating the mallampati score, mandible protrusion or body mass index still not 100% specifically say anything. We compare 4 different video laryngoscopes for preoperative assessment of difficult laryngoscopy.
Detailed description
preoperative assessment of difficult airways are the subject of debate. Now, measuring the thyromental distance or evaluating the mallampati score, mandible protrusion or body mass index still not 100% specifically say anything. all patients were pre oxygenated with 100% oxygen with nasal canulla during the whole procedure. We administered 0.07 mgr/kg remifentanil for minimum 3 minutes and continue this infusion during the procedure. The patients airway topicalized by 10% lidocaine spray. We enroll 20 patients undergoing elective surgery.
We compare 4 different video laryngoscopes for preoperative assessment of difficult laryngoscopy in the same patient. We evaluate the patient and the instructors satisfaction with the visual analogy scale and the visualization time. Demographic vary,ables and the airway characteristics of patients. We assess the cormack lehane view of these videolaryngoscopes with or without cricoid pressure. and the occurrence of gag reflex as well.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- We used these 4 video laryngoscopes ( c-mac, d-blade, macgrath mac x-blade and airtraq) on the same patient.
| Arm | Type | Receives |
|---|---|---|
| satisfaction of instructor | Active comparator | Device: airtraq, Device: mcgrath mac x-blade, Device: storz c-mac, Device: storz d-bladevisual analogy scale of the satisfaction of the instructor was recorded |
| satisfaction of the patient | Active comparator | Device: airtraq, Device: mcgrath mac x-blade, Device: storz c-mac, Device: storz d-bladevisual analogy scale of the satisfaction of the patient was recorded |
| duration of view | Active comparator | Device: airtraq, Device: mcgrath mac x-blade, Device: storz c-mac, Device: storz d-bladeduration of the visualization the vocal cords was recorded |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- body mass index < 30
- no difficult airway history or predictor,
- no respiratory tract infections for ten days,
- Exclusion Criteria: BMI > 35, < 18 or > 60 years of age, expected difficult airway, pregnant
- -
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| airtraqAlso: videolaryngoscopeairtraq videolaryngoscope | Device | duration of view, satisfaction of instructor, satisfaction of the patient |
| mcgrath mac x-bladeAlso: videolaryngoscopemcgarth mac videolaryngoscope | Device | duration of view, satisfaction of instructor, satisfaction of the patient |
| storz c-macAlso: videolaryngoscopestorz c-mac videolaryngoscope | Device | duration of view, satisfaction of instructor, satisfaction of the patient |
| storz d-bladeAlso: videolaryngoscopestorz d-blade video laryngoscope | Device | duration of view, satisfaction of instructor, satisfaction of the patient |
Primary outcome
satisfaction of the instructor: visual analogy scale
Time frame: 2 minutes
visual analogy scale of the satisfaction
2 secondary outcomes
satisfaction of the patient: visual analogy scale
Time frame: 2 minutes
duration view
Time frame: 10 seconds
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 23 Oct 2019.
- Individual participant dataSharing planned: No
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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.
Zehra I Arslan study chair
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing airtraq, mcgrath mac x-blade and storz c-mac in people with Assessment and Difficult Airway Intubation, run by Kocaeli 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 5 inclusion and 0 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 23 Oct 2019. 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?
satisfaction of the instructor: visual analogy scale (time frame: 2 minutes). 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 23 Oct 2019.