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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

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 groups in NCT03075033
Study groupRoleWhat they receive
SOS gruopActive comparatorUse of The Shikani Optical Stylet In Patients At Risk Of Secondary Cervical Spine Injury
Receives: Device: Shikani optical stylet
Awake Fiberoptic IntubationActive comparatorUse 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.

  1. 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

  2. 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

  3. Number of attempts for successful intubation

    How many trials were taken till achieve the intubation

    Measured: During intubation

  4. 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.

  1. First posted9 Mar 2017
  2. Study startJan 2014
  3. Primary completionJun 2016
  4. Study completionAug 2016

Resources

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)
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

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.

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