SOS Versus Awake Fiberoptic Intubation

NCT03075033 | Completed

• 1 other identifier: Shikani2017
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Cervical Spine Instability

Keywords

Shikani optical stylet, rigid optical stylets, awake, fiber-optic intubation, and cervical spine injury.

Outcome Measures

Primary Outcomes (4)

• 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\]

  during and after intubation

• Time to intubation

  Measure the time in minutes from the start of intubation to the completion of intubation

  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

  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.

  Pre-induction, pre-intubation and at 3 and 5 min after intubation

Study Arms (2)

SOS gruop

ACTIVE COMPARATOR

Use of The Shikani Optical Stylet In Patients At Risk Of Secondary Cervical Spine Injury

Device: Shikani optical stylet

Awake Fiberoptic Intubation

ACTIVE COMPARATOR

Use of Awake Fiberoptic Intubation In Patients At Risk Of Secondary Cervical Spine Injury

Device: Flexible fiberoptic bronchoscope for

Interventions

Shikani optical stylet DEVICE

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.

SOS gruop

Flexible fiberoptic bronchoscope for DEVICE

AwakeRracheal intubation using flexible fiberoptic bronchoscope in patients with cervical spine instability

Awake Fiberoptic Intubation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alexandria: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 28, 2017
• First Posted: March 9, 2017
• Study Start: January 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: August 1, 2016
• Last Updated: March 13, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share