Injury of Cervical SpinePhase 4NCT02245880
Tracheal Intubation With Collar Immobilisation : a Comparison of Glidescope and Fastrach
A Phase 4 study testing Glidescope and ILMA in people with Injury of Cervical Spine, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
Intubation must be done with utmost care in cervical trauma patients. cervical spine motion must be minimized and intubation must be fast. The aim of this study was to compare the effectiveness of fastrach and glidescope. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Injury of Cervical Spine
- What is being tested?
- Glidescope and ILMA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Apr 2014to Sep 2014
- 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
- 18-65 years of age
- ASA I-II
- requiring intubation
- BMI<35
Who cannot join
- less than 18 or higher than 65
- ASA III-IV
- BMI> 35
- PREGNANT
- head and neck tumors
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: A Comparison of Glidescope and ILMA in Simulated Sercial Spine Injury
Intubation must be done with utmost care in cervical trauma patients. cervical spine motion must be minimized and intubation must be fast. The aim of this study was to compare the effectiveness of fastrach and glidescope. 18-65 years of age , ASA I-II 100 patients undergoing elective surgery were enrolled in this trial. After standard monitorisation including EKG , noninvasive blood pressure, pulse oximetry, anesthesia was induced with propofol and fentanyl. rocuronium was then administered for muscle relaxation. Patients were divided into two groups glidescope and fastrach. Rigid collar was placed then patients were intubated with one of these devices. Mask ventilations with or without collar were recorded. insertion times, intubation times of the devices were recorded. Peroperative hemodynamic parameters and postoperative minor complications were also recoded.
Read the detailed description
inclusion criteria: ASA I-II , 18-60 years of age undergoing elective surgery requiring intubation exclusion criteria:
- pregnancy reflux nonfasted head and neck tumors recent flue in 2 weeks
- Conditions
- Injury of Cervical Spine
- Being tested
- Glidescope, ILMA
- Keywords
- cervical spine, intubating laryngeal mask airway, Glidescope videolaryngoscope, collar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlidescopeDevice
videolaryngoscope
ILMADevice
Also called FASTRACH
handling of the device till the optimal ventilation achieved
| Study group | Role | What they receive |
|---|---|---|
| Glidescope videolaryngoscope | Active comparator | cervical collar was applied to 47 patients then facemask ventilations were recoded intubated with Glidescope and insertion time: handling of the device till the good glottic visualisation intubation time: handling of the device till the capnography appears mucosal damage: bloodstain on the device after removal heart rate preinduction heart rate postinduction heart rate postinsertion heart rate postintubation mean arterial pressure preinduction mean arterial pressure postinduction mean arterial pressure postinsertion mean arterial pressure postintubation wrere recorded. postoperative minor complications were recorded. Receives: Device: Glidescope |
| Intubating laryngeal mask airway | Active comparator | cervical collar was applied to 47 patients then facemask ventilations through the collar were recorded and intubated with ILMA insertion time: handling of the device till the good glottic visualisation appears intubation time: handling of the device till the capnography appears mucosal damage: bloodstain on the device heart rate preinduction heart rate postinduction heart rate posinsertion heart rate postintubation mean arterial pressure preinduction mean arterial pressure postinduction mean arterial pressure postinsertion mean arterial pressure postintubation Receives: Device: ILMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
intubation times
Measured: From handling of the device till intıbation
Secondary outcomes (2)
Heart rate
Measured: From Preoperative heart rate till 15 minutes After intubation
Mean arterial pressure
Measured: From preinduction till 15 minutes after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2014 (estimated)
- Study startApr 2014
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injury of Cervical SpineStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 94 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, Specialist, Principal investigator, Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02245880
- Sponsor's protocol ID
- KOÜ KAEK 2013/33
- Status last verified
- Mar 2015
- First submitted
- 17 Apr 2014
- Last updated
- 1 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Glidescope and ILMA in Simulated Sercial Spine Injury
- ClinicalTrials.gov ID
- NCT02245880
- Acronym / sponsor ID
- KOÜ KAEK 2013/33
- Conditions
- Injury of Cervical Spine
- Keywords
- cervical spine, intubating laryngeal mask airway, Glidescope videolaryngoscope, collar
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 22 Sep 2014 (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.
Intubation must be done with utmost care in cervical trauma patients. cervical spine motion must be minimized and intubation must be fast. The aim of this study was to compare the effectiveness of fastrach and glidescope. 18-65 years of age , ASA I-II 100 patients undergoing elective surgery were enrolled in this trial. After standard monitorisation including EKG , noninvasive blood pressure, pulse oximetry, anesthesia was induced with propofol and fentanyl. rocuronium was then administered for muscle relaxation. Patients were divided into two groups glidescope and fastrach. Rigid collar was placed then patients were intubated with one of these devices. Mask ventilations with or without collar were recorded. insertion times, intubation times of the devices were recorded. Peroperative hemodynamic parameters and postoperative minor complications were also recoded.
Detailed description
inclusion criteria: ASA I-II , 18-60 years of age undergoing elective surgery requiring intubation exclusion criteria:
- pregnancy reflux nonfasted head and neck tumors recent flue in 2 weeks
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glidescope videolaryngoscope | Active comparator | Device: Glidescopecervical collar was applied to 47 patients then facemask ventilations were recoded intubated with Glidescope and insertion time: handling of the device till the good glottic visualisation intubation time: handling of the device till the capnography appears mucosal damage: bloodstain on the device after removal heart rate preinduction heart rate postinduction heart rate postinsertion heart rate postintubation mean arterial pressure preinduction mean arterial pressure postinduction mean arterial pressure postinsertion mean arterial pressure postintubation wrere recorded. postoperative minor complications were recorded. |
| Intubating laryngeal mask airway | Active comparator | Device: ILMAcervical collar was applied to 47 patients then facemask ventilations through the collar were recorded and intubated with ILMA insertion time: handling of the device till the good glottic visualisation appears intubation time: handling of the device till the capnography appears mucosal damage: bloodstain on the device heart rate preinduction heart rate postinduction heart rate posinsertion heart rate postintubation mean arterial pressure preinduction mean arterial pressure postinduction mean arterial pressure postinsertion mean arterial pressure postintubation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-65 years of age
- ASA I-II
- requiring intubation
- BMI<35
Key exclusion criteria (5 listed)
- less than 18 or higher than 65
- ASA III-IV
- BMI> 35
- PREGNANT
- head and neck tumors
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 |
|---|---|---|
| Glidescopevideolaryngoscope | Device | Glidescope videolaryngoscope |
| ILMAAlso: FASTRACHhandling of the device till the optimal ventilation achieved | Device | Intubating laryngeal mask airway |
Primary outcome
intubation times
Time frame: From handling of the device till intıbation
2 secondary outcomes
Heart rate
Time frame: From Preoperative heart rate till 15 minutes After intubation
Mean arterial pressure
Time frame: From preinduction till 15 minutes after 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 1 Apr 2015.
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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, Specialist principal investigator
Anesthesiology and Reanimation
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 Glidescope and ILMA in people with Injury of Cervical Spine, 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 4 inclusion and 5 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 1 Apr 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?
intubation times (time frame: From handling of the device till intıbation). 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 1 Apr 2015.