Rapid Sequence Induction IntubationPhase 4NCT02588157
Effect of Cricoid Pressure on Macintosh, McGrath X-Blade and Glidescope Videolaryngoscopes in Rapid Sequence Induction Intubation
A Phase 4 study testing Macintosh, Glidescope and McGrath MAC X-Blade in people with Rapid Sequence Induction Intubation, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
Non- Fasted patients need rapid sequence intubation. The investigators aimed to compare the intubation times of Macintosh , and McGrath X-Blade or Glidescope in these Ascenario. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Rapid Sequence Induction Intubation
- What is being tested?
- Macintosh, Glidescope and McGrath MAC X-Blade
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2015to Feb 2016
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-II
- BMI< 30
- 18-65 years of age
Who cannot join
- known difficult airway
- BMI > 30
- < 18 years of age
- > 65 years of age
- known respiratory tract infection in 10 days
- pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Videolaryngoscopes for Rapid Sequence Intubation
Non- Fasted patients need rapid sequence intubation. The investigators aimed to compare the intubation times of Macintosh , and McGrath X-Blade or Glidescope in these Ascenario.
Read the detailed description
The investigators fecidedir to enroll the ASA I-II 120 patients and divided them into three groups ( Macintosh / McGarth X-Blade / Glidescope). The investigators recorded the patients' airway data and demographic variables. All patients were premeditated with midazolam. Standard monitoring including electrocardiogram, non invasive blood pressure, pulse oximetry, heart rate were recorded before induction , after induction, after the device insertion and every 1 minutes after intubation. Cormac-Lehan grades with these video laryngoscope were recorded also. We recorded the optimization maneuvers ( like handling force, reinserting, cricoid pressure). Bloodstaining on the devices after removal were recorded as mucosal damage. Teeth, tongue, lip damage were also recorded. Sore throat, bronchospasm, wheezing were recored at recovery unit.
- Conditions
- Rapid Sequence Induction Intubation
- Being tested
- Macintosh, Glidescope, McGrath MAC X-Blade
- Keywords
- Rapid sequence induction intubation, McGrath X-Blade, Glidescope, Macintosh
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MacintoshDevice
Also called direct laryngoscopy
Direct laryngoscopy
GlidescopeDevice
Also called videolaryngoscope
Glidescope videolaryngoscope
McGrath MAC X-BladeDevice
Also called videolaryngoscope
McGrath MAC X-Blade videolaryngoscope
| Study group | Role | What they receive |
|---|---|---|
| İnsertion time | Active comparator | handling the device till the glottic visualisation of Macintosh, McGrath MAC X-Blade and Glidescope Receives: Device: Macintosh; Device: Glidescope; Device: McGrath MAC X-Blade |
| intubation time | Active comparator | handling the device till seeing the endotracheal tube entering from the vocal cords Macintosh, McGrath MAC X-Blade and Glidescope Receives: Device: Macintosh; Device: Glidescope; Device: McGrath MAC X-Blade |
What is being measured
The primary outcome is the main question the study is designed to answer.
cormack lehane grade with cricoid pressure
Measured: 1 minutes
intubation time
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rapid Sequence Induction IntubationStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zehra Ipek ARSLAN, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02588157
- Sponsor's protocol ID
- KOÜ KAEK 2015/267
- Status last verified
- Jul 2016
- First submitted
- 26 Oct 2015
- Last updated
- 20 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Videolaryngoscopes for Rapid Sequence Intubation
- ClinicalTrials.gov ID
- NCT02588157
- Acronym / sponsor ID
- KOÜ KAEK 2015/267
- Conditions
- Rapid Sequence Induction Intubation
- Keywords
- Rapid sequence induction intubation, McGrath X-Blade, Glidescope, Macintosh
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 27 Oct 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.
Non- Fasted patients need rapid sequence intubation. The investigators aimed to compare the intubation times of Macintosh , and McGrath X-Blade or Glidescope in these Ascenario.
Detailed description
The investigators fecidedir to enroll the ASA I-II 120 patients and divided them into three groups ( Macintosh / McGarth X-Blade / Glidescope). The investigators recorded the patients' airway data and demographic variables. All patients were premeditated with midazolam. Standard monitoring including electrocardiogram, non invasive blood pressure, pulse oximetry, heart rate were recorded before induction , after induction, after the device insertion and every 1 minutes after intubation. Cormac-Lehan grades with these video laryngoscope were recorded also. We recorded the optimization maneuvers ( like handling force, reinserting, cricoid pressure). Bloodstaining on the devices after removal were recorded as mucosal damage. Teeth, tongue, lip damage were also recorded. Sore throat, bronchospasm, wheezing were recored at recovery unit.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| İnsertion time | Active comparator | Device: Macintosh, Device: Glidescope, Device: McGrath MAC X-Bladehandling the device till the glottic visualisation of Macintosh, McGrath MAC X-Blade and Glidescope |
| intubation time | Active comparator | Device: Macintosh, Device: Glidescope, Device: McGrath MAC X-Bladehandling the device till seeing the endotracheal tube entering from the vocal cords Macintosh, McGrath MAC X-Blade and Glidescope |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I-II
- BMI< 30
- 18-65 years of age
Key exclusion criteria (6 listed)
- known difficult airway
- BMI > 30
- < 18 years of age
- > 65 years of age
- known respiratory tract infection in 10 days
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 |
|---|---|---|
| MacintoshAlso: direct laryngoscopyDirect laryngoscopy | Device | intubation time, İnsertion time |
| GlidescopeAlso: videolaryngoscopeGlidescope videolaryngoscope | Device | intubation time, İnsertion time |
| McGrath MAC X-BladeAlso: videolaryngoscopeMcGrath MAC X-Blade videolaryngoscope | Device | intubation time, İnsertion time |
Primary outcome
cormack lehane grade with cricoid pressure
Time frame: 1 minutes
intubation time
Time frame: 2 minutes
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 20 Jul 2016.
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Anesthesia
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.
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 Macintosh, Glidescope and McGrath MAC X-Blade in people with Rapid Sequence Induction 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 3 inclusion and 6 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 20 Jul 2016. 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?
cormack lehane grade with cricoid pressure (time frame: 1 minutes). The study lists 2 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 20 Jul 2016.