Cervical Spine InstabilityNCT03075033
SOS Versus Awake Fiberoptic Intubation
A study testing Shikani optical stylet and Flexible fiberoptic bronchoscope for in people with Cervical Spine Instability, run by University of Alexandria.
Trial summary
Background: Conventional intubation of the trachea and consequent prone positioning of anaesthetized patients with cervical spine instability may result in secondary neurological injury. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cervical Spine Instability
- What is being tested?
- Shikani optical stylet and Flexible fiberoptic bronchoscope for
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Aug 2016
- 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
- American Society of Anaesthesiologists physical status I-III with a neurosurgical diagnosis of cervical instability or at risk of secondary cervical injury, who were scheduled for awake intubation and self-positioning prone for elective neurological intervention
Who cannot join
- Patients with increased risk of pulmonary aspiration, requirement for rapid sequence induction or associated head injury precluding adequate clinical neurological examination were excluded from the study.
About this study
Official title: The Shikani Optical Stylet As An Alternative To Awake Fiberoptic Intubation In Patients At Risk Of Secondary Cervical Spine Injury - A Randomized Controlled Trial.
Background: Conventional intubation of the trachea and consequent prone positioning of anaesthetized patients with cervical spine instability may result in secondary neurological injury. Historically, the flexible fiber-optics used to be the chief choice for patients presenting with cervical spine instability surgery either with normal, predicted difficult airway, or even unanticipated difficult airway. Recently, the rigid optical stylets have shown promise in assisting difficult intubations.
Purpose: The aim of the present study was to compare the efficacy of Shikani optical stylet (SOS) with the flexible fiberscope for awake intubation in patients with cervical spine instability.
Methods: Sixty adult patients with a neurosurgical diagnosis of cervical instability or at risk of secondary cervical injury, who were planned for awake intubation and self-positioning prone, were registered in this study and were randomly categorized into two equal groups (thirty patients each), a fiberoptic group and a SOS group, then assessment of coughing and gagging during and after intubation, time to intubation, number of attempts for successful intubation, haemodynamic parameters, careful examination of the oropharynx to determine any lip or mucosal trauma, and eventually the motor function by the ability to move arms and legs were assessed after tracheal intubation and after positioning prone.
Read the detailed description
Aim of the work:
The aim of this study was to compare the efficacy of shikani optical stylet with the flexible fiberoptic bronchoscope for awake intubation in patients with cervical spine instability.
Patients and Methods:
This prospective, randomized study was approved by the local ethical committee of Alexandria main university hospital. Written informed consent was obtained from all the participants. Sixty patients aged 18-65 year with American Society of Anaesthesiologists physical status I-III with a neurosurgical diagnosis of cervical instability or at risk of secondary cervical injury, who were scheduled for awake intubation and self-positioning prone for elective neurological intervention, were enrolled in this study. Patients with increased risk of pulmonary aspiration, requirement for rapid sequence induction or associated head injury precluding adequate clinical neurological examination were excluded from the study. All patients received rigid neck collar. Data collected from each patient included demographic data, level of cervical spine pathology and the neurological status.
An assistant who wasn't concerned within this study got numbered opaque pre-sealed envelopes containing the randomised group allocations after every patient was joined into the study. Patients were randomly assigned into either a fiberoptic group (30) or a Shikani group (30) utilizing a sealed-envelope technique.
Anaesthetists concerned within the study had expertise with both devices and were assured in consuming the devices in a difficult airway situation.
Routin pre-anaesthetic assessments were performed, in addition to a standard airway assessment, recording the presence of any oro-pharyngeal injury before surgery. Non-invasive monitoring was used before intubation comprising pulse oximetry, blood pressure and electrocardiography. Before starting topical anaesthesia, all patients were given atropine 0.4 mg as an anti sialagogue agent, midazolam 2 mg and increments of fentanyl 25mic intravenously till the patient is calm and sedated but controlling his airway.
Topical anaesthesia of the oral cavity was performed with lidocaine 10% spray. Anesthesia of the larynx just above the vocal cords, vocal cords and the upper trachea was encountered with superior laryngeal nerves block using 4 ml of 2% lidocaine (2 ml on each side), at the lateral ends of the thyrohyoid membrane just beneath the greater cornu of the hyoid bone and recurrent laryngeal nerve block (Trans-tracheal injection) using a 20-gauge plastic catheter, 4ml of 2% lidocaine through the cricothyroid membrane at the end of inspiration.
Tracheal intubation was then executed with either the flexible fiberoptic bronchoscope or the Shikani optical stylet, according to the randomised allocation. The shikani optical stylet was bent to the same bend as a Mackintosh laryngoscope blade, lubricated and the endotracheal tube was mounted on it. The tube was settled to the stylet by the 'adjustable tube stop' so that the tip of the stylet did not project beyond the end of the tube. The anaesthetist hold and elevated the mandible using the left hand, the patient was asked to protrude his tongue if applicable and the stylet was introduced into the right side of the mouth and advanced until the tip was in hypopharynx. Then, under direct vision the tip was inserted between the vocal cords.The 'tube stop' was released and the tube was unmounted into the trachea; the stylet was removed. Once tracheal intubation was accomplished, confirmation of the position of endotracheal tube by capnography and chest auscultation. The patients were then asked to move to the prone position on the bolsters, in the cases planned for posterior approach of the cervical spine. The anaesthesia provider guarded the head and tube during the move and neurological examination was repeated. Once the position is settled, the presence of end tidal carbon dioxide was confirmed and general anaesthesia was set up.
- Conditions
- Cervical Spine Instability
- Being tested
- Shikani optical stylet, Flexible fiberoptic bronchoscope for
- Keywords
- Shikani optical stylet, rigid optical stylets, awake, fiber-optic intubation, and cervical spine injury.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shikani optical styletDevice
Tracheal intubation is performed using Shikani optical stylet. The shikani optical stylet was bent to the same bend as a Mackintosh laryngoscope blade, lubricated and the endotracheal tube was mounted on it. The tube was settled to the stylet by the 'adjustable tube stop' so that the tip of the stylet did not project beyond the end of the tube. After intubation the 'tube stop' was released and the tube was unmounted into the trachea; the stylet was removed.
Flexible fiberoptic bronchoscope forDevice
AwakeRracheal intubation using flexible fiberoptic bronchoscope in patients with cervical spine instability
| Study group | Role | What they receive |
|---|---|---|
| SOS gruop | Active comparator | Use of The Shikani Optical Stylet In Patients At Risk Of Secondary Cervical Spine Injury Receives: Device: Shikani optical stylet |
| Awake Fiberoptic Intubation | Active comparator | Use of Awake Fiberoptic Intubation In Patients At Risk Of Secondary Cervical Spine Injury Receives: Device: Flexible fiberoptic bronchoscope for |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coughing and gagging
using a scale of 1 to 4: (1= none; 2 < 3 times (slight coughing and gagging comparable to "clearing ones throat"); 3 > 2 times (mild coughing or gagging lasting less than a minute); 4 = persistent coughing or gagging]
Measured: during and after intubation
Time to intubation
Measure the time in minutes from the start of intubation to the completion of intubation
Measured: the interval from the start of intubation to the completion of intubation
Number of attempts for successful intubation
How many trials were taken till achieve the intubation
Measured: During intubation
The changes in the haemodynamic parameters
the haemodynamic parameters including: heart rate, systolic and diastolic blood pressures during the intubation process with readings taken pre-induction, pre-intubation and at 3 and 5 min after intubation.
Measured: Pre-induction, pre-intubation and at 3 and 5 min after intubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study startJan 2014
- Primary completionJun 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Spine InstabilityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This prospective, randomized study was approved by the local ethical committee of Alexandria main university hospital. Written informed consent was obtained from all the participants. Sixty patients aged 18-65 year with American Society of Anaesthesiologists physical status I-III with a neurosurgical diagnosis of cervical instability or at risk of secondary cervical injury, who were scheduled for awake intubation and self-positioning prone for elective neurological intervention, were enrolled in this study.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alexandria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rabab Sber Saleh Mahrous, University of Alexandria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03075033
- Sponsor's protocol ID
- Shikani2017
- Status last verified
- Mar 2017
- First submitted
- 28 Feb 2017
- Last updated
- 13 Mar 2017
- 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 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Shikani Optical Stylet As An Alternative To Awake Fiberoptic Intubation In Patients At Risk Of Secondary Cervical Spine Injury - A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03075033
- Acronym / sponsor ID
- Shikani2017
- Conditions
- Cervical Spine Instability
- Keywords
- Shikani optical stylet, rigid optical stylets, awake, fiber-optic intubation, and cervical spine injury.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of AlexandriaUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Jun 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 9 Mar 2017 (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.
Background: Conventional intubation of the trachea and consequent prone positioning of anaesthetized patients with cervical spine instability may result in secondary neurological injury. Historically, the flexible fiber-optics used to be the chief choice for patients presenting with cervical spine instability surgery either with normal, predicted difficult airway, or even unanticipated difficult airway. Recently, the rigid optical stylets have shown promise in assisting difficult intubations.
Purpose: The aim of the present study was to compare the efficacy of Shikani optical stylet (SOS) with the flexible fiberscope for awake intubation in patients with cervical spine instability.
Methods: Sixty adult patients with a neurosurgical diagnosis of cervical instability or at risk of secondary cervical injury, who were planned for awake intubation and self-positioning prone, were registered in this study and were randomly categorized into two equal groups (thirty patients each), a fiberoptic group and a SOS group, then assessment of coughing and gagging during and after intubation, time to intubation, number of attempts for successful intubation, haemodynamic parameters, careful examination of the oropharynx to determine any lip or mucosal trauma, and eventually the motor function by the ability to move arms and legs were assessed after tracheal intubation and after positioning prone.
Detailed description
Aim of the work:
The aim of this study was to compare the efficacy of shikani optical stylet with the flexible fiberoptic bronchoscope for awake intubation in patients with cervical spine instability.
Patients and Methods:
This prospective, randomized study was approved by the local ethical committee of Alexandria main university hospital. Written informed consent was obtained from all the participants. Sixty patients aged 18-65 year with American Society of Anaesthesiologists physical status I-III with a neurosurgical diagnosis of cervical instability or at risk of secondary cervical injury, who were scheduled for awake intubation and self-positioning prone for elective neurological intervention, were enrolled in this study. Patients with increased risk of pulmonary aspiration, requirement for rapid sequence induction or associated head injury precluding adequate clinical neurological examination were excluded from the study. All patients received rigid neck collar. Data collected from each patient included demographic data, level of cervical spine pathology and the neurological status.
An assistant who wasn't concerned within this study got numbered opaque pre-sealed envelopes containing the randomised group allocations after every patient was joined into the study. Patients were randomly assigned into either a fiberoptic group (30) or a Shikani group (30) utilizing a sealed-envelope technique.
Anaesthetists concerned within the study had expertise with both devices and were assured in consuming the devices in a difficult airway situation.
Routin pre-anaesthetic assessments were performed, in addition to a standard airway assessment, recording the presence of any oro-pharyngeal injury before surgery. Non-invasive monitoring was used before intubation comprising pulse oximetry, blood pressure and electrocardiography. Before starting topical anaesthesia, all patients were given atropine 0.4 mg as an anti sialagogue agent, midazolam 2 mg and increments of fentanyl 25mic intravenously till the patient is calm and sedated but controlling his airway.
Topical anaesthesia of the oral cavity was performed with lidocaine 10% spray. Anesthesia of the larynx just above the vocal cords, vocal cords and the upper trachea was encountered with superior laryngeal nerves block using 4 ml of 2% lidocaine (2 ml on each side), at the lateral ends of the thyrohyoid membrane just beneath the greater cornu of the hyoid bone and recurrent laryngeal nerve block (Trans-tracheal injection) using a 20-gauge plastic catheter, 4ml of 2% lidocaine through the cricothyroid membrane at the end of inspiration.
Tracheal intubation was then executed with either the flexible fiberoptic bronchoscope or the Shikani optical stylet, according to the randomised allocation. The shikani optical stylet was bent to the same bend as a Mackintosh laryngoscope blade, lubricated and the endotracheal tube was mounted on it. The tube was settled to the stylet by the 'adjustable tube stop' so that the tip of the stylet did not project beyond the end of the tube. The anaesthetist hold and elevated the mandible using the left hand, the patient was asked to protrude his tongue if applicable and the stylet was introduced into the right side of the mouth and advanced until the tip was in hypopharynx. Then, under direct vision the tip was inserted between the vocal cords.The 'tube stop' was released and the tube was unmounted into the trachea; the stylet was removed. Once tracheal intubation was accomplished, confirmation of the position of endotracheal tube by capnography and chest auscultation. The patients were then asked to move to the prone position on the bolsters, in the cases planned for posterior approach of the cervical spine. The anaesthesia provider guarded the head and tube during the move and neurological examination was repeated. Once the position is settled, the presence of end tidal carbon dioxide was confirmed and general anaesthesia was set up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- This prospective, randomized study was approved by the local ethical committee of Alexandria main university hospital. Written informed consent was obtained from all the participants. Sixty patients aged 18-65 year with American Society of Anaesthesiologists physical status I-III with a neurosurgical diagnosis of cervical instability or at risk of secondary cervical injury, who were scheduled for awake intubation and self-positioning prone for elective neurological intervention, were enrolled in this study.
| Arm | Type | Receives |
|---|---|---|
| SOS gruop | Active comparator | Device: Shikani optical styletUse of The Shikani Optical Stylet In Patients At Risk Of Secondary Cervical Spine Injury |
| Awake Fiberoptic Intubation | Active comparator | Device: Flexible fiberoptic bronchoscope forUse of Awake Fiberoptic Intubation In Patients At Risk Of Secondary Cervical Spine Injury |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American Society of Anaesthesiologists physical status I-III with a neurosurgical diagnosis of cervical instability or at risk of secondary cervical injury, who were scheduled for awake intubation and self-positioning prone for elective neurological intervention
Key exclusion criteria (1 listed)
- Patients with increased risk of pulmonary aspiration, requirement for rapid sequence induction or associated head injury precluding adequate clinical neurological examination were excluded from the study.
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 |
|---|---|---|
| Shikani optical styletTracheal intubation is performed using Shikani optical stylet. The shikani optical stylet was bent to the same bend as a Mackintosh laryngoscope blade, lubricated and the endotracheal tube was mounted on it. The tube was settled to the stylet by the 'adjustable tube stop' so that the tip of the stylet did not project beyond the end of the tube. After intubation the 'tube stop' was released and the tube was unmounted into the trachea; the stylet was removed. | Device | SOS gruop |
| Flexible fiberoptic bronchoscope forAwakeRracheal intubation using flexible fiberoptic bronchoscope in patients with cervical spine instability | Device | Awake Fiberoptic Intubation |
Primary outcome
Coughing and gagging
Time frame: during and after intubation
using a scale of 1 to 4: (1= none; 2 < 3 times (slight coughing and gagging comparable to "clearing ones throat"); 3 > 2 times (mild coughing or gagging lasting less than a minute); 4 = persistent coughing or gagging]
Time to intubation
Time frame: the interval from the start of intubation to the completion of intubation
Measure the time in minutes from the start of intubation to the completion of intubation
Number of attempts for successful intubation
Time frame: During intubation
How many trials were taken till achieve the intubation
The changes in the haemodynamic parameters
Time frame: Pre-induction, pre-intubation and at 3 and 5 min after intubation
the haemodynamic parameters including: heart rate, systolic and diastolic blood pressures during the intubation process with readings taken pre-induction, pre-intubation and at 3 and 5 min 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 13 Mar 2017.
- Individual participant dataSharing planned: No
Related trials for Cervical Spine Instability
RecruitingObservational study
Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Cervical
Spine Fracture, Degenerative Disc Disease
Enrolling by invitationObservational study
Posterior Cervical Fixation Study
Degenerative Disc Disease, Craniocervical Injuries
Enrolling by invitationObservational study
Cervical Interbody Implant Study
Degenerative Disc Disease, Cervical Spinal Instability
Active, not recruitingObservational study
Cervical Spine Abnormalities in Down Syndrome
Down Syndrome, Cervical Spine Instability in Down Syndrome
Enrolling by invitationObservational study
Treatment of One and/or Two Level Cervical Degenerative Disc Disease
Cervical Radiculopathy
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 Shikani optical stylet and Flexible fiberoptic bronchoscope for in people with Cervical Spine Instability, run by University of Alexandria.
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 1 inclusion and 1 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 13 Mar 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?
Coughing and gagging (time frame: during and after 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 13 Mar 2017.