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Anesthesia Intubation ComplicationNCT02614924

Comparison of Flexible Fibreoptic Scope With Pentax AWS Videolaryngoscope for Ease of Intubation During Awake Intubation

A study testing Flexible fibreoptic scope and Pentax AWS videolaryngoscope in people with Anesthesia Intubation Complication, run by University Hospitals Coventry and Warwickshire NHS Trust.

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

The purpose of this study is to identify whether Pentax Airway Scope (AWS) videolaryngoscope would be a more effective device compared to flexible fibreoptic scope (FOS) for awake intubation in a difficult airway. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anesthesia Intubation Complication
What is being tested?
Flexible fibreoptic scope and Pentax AWS videolaryngoscope
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
No sites listed yet
Study dates
Nov 2012to Jul 2014
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with cervical spine disease presenting for cervical spinal surgery and requiring awake intubation under local anaesthesia and conscious sedation.
  • Patients with anticipated difficult airway include those with Mallampati class 3 and above, other signs such as limited neck movement and limited jaw protrusion will be include in the study

Who cannot join

  • Children below 18 years of age, pregnant mothers and patients presenting with airway pathology will be excluded.

About this study

The purpose of this study is to identify whether Pentax Airway Scope (AWS) videolaryngoscope would be a more effective device compared to flexible fibreoptic scope (FOS) for awake intubation in a difficult airway.

Read the detailed description

Background:

The incidence of difficult tracheal intubation during routine anaesthesia in general population is around 3-18% although it varies [1]. Awake intubation is considered in situations such as in patients with a known or suspected difficult airway, upper airway obstruction. Awake intubation under local anaesthesia and sedation also indicated cervical spine disease in view of minimising movement of cervical spine [2]. Any technique tracheal intubation under general anaesthesia involves some degree of movement at cervical spine. Direct laryngoscopy and tracheal intubation in under general anaesthesia is usually achieved by flexion of lower cervical spine and extension at atlanto-occipital joint [3]. Difficulties or failure in airway management is still an important factor in morbidity and mortality related to anaesthesia.

In recent years videolaryngoscopes have been used as an alternative to traditional fibreoptic scope in the management of difficult airway [4,7,8]. Over last 2 years in our institution the investigators have used Pentax AWS videolaryngoscope for awake intubation in patients presenting for surgery with cervical spine disease [9, 10].

However there has not been any study comparing flexible fibreoptic scope with video laryngoscopes in the management of difficult airway in awake patients. The proposed benefits of Pentax AWS (Airway scope) over a flexible fibreoptic scope include ease of setting up the device, less complexity of the skill, therefore easy to learn the skill and availability of disposable devices minimising the need for cleaning and disinfecting the device.

Pentax AWS with PBlade videolaryngoscope has a unique target symbol displayed on the monitor, which highlights the intended path of the endotracheal tube. The Pentax PBlade is a single patient use device that minimizes the risk of infection.

Study Design and Methods: Randomised Controlled Trial

Patient Selection:

Forty patients presenting for cervical spine surgery under general anaesthesia and requiring oral endotracheal intubation will be invited to take part in the study. During preoperative visit, a patient information sheet will be given to the patients meeting the eligible criteria. The patient will be given adequate time to read the information sheet and any queries will be answered. Wherever possible, suitable patients will be identified in the preoperative assessment clinic. A detailed airway assessment will be performed by one of the investigator.

Whenever possible, when patients are admitted the night before their operation, they should be seen by an Anaesthetist and given the study information.

Techniques of Anaesthesia:

After securing intravenous cannulation and instituting standard anaesthetic monitoring with ECG, pulse oximetry and non-invasive blood pressure monitoring, conscious sedation will be started using target controlled infusion of remifentanil and 1 mg of midazolam. At this stage numbered opaque envelope will be opened to choose one of the two devices. The tongue, oropharynx and larynx will be anaesthetised using 4% lignocaine using Mckenzie technique (nebulisation of local anaesthetic through 20 G cannula).

Adequate anaesthesia of upper airway will be checked by inserting an appropriately sized oropharyngeal airway (if the patient can tolerate well, the airway is anesthetised adequately, if not further local anaesthetic is administered to the oropharynx). After confirming adequate anaesthesia of upper airway, the chosen device will be inserted into the oropharynx. Further local anaesthesia to the base of the tongue, larynx and trachea will be administered using spray as you go technique where the local anaesthetic administered through the device whilst gradually advancing the device towards larynx. After confirming the position of the tracheal tube and testing the gross neurological state of all 4 limbs, general anaesthesia will be induced.

Data Collection:

During the procedure of laryngoscopy and endotracheal intubation, a modified intubation difficulty score (IDS) would be developed based on the parameter recorded. Along with intubation difficulty score other parameters compared include: time taken to complete the process of intubation, anaesthetist rating of intubation and patient rating of procedure.

The following parameter would be recorded and scored:

  1. Coughing episode: 0 no cough 1 if mild cough, 2 if moderate cough, 3 if severe cough.
  2. Gagging episode: 0 no gagging, 1 if mild gag, 2 if moderate gag, 3 if severe gag.
  3. Ease of insertion of device: 0 easy, 1 if mild difficulty 2 if moderately difficulty, 3 very difficult.
  4. Laryngoscope view based on the percentage of the glottis visualised 0 if 75-100% view, 1 if 50-75% view, 2 if <50% view, 3 no VC visible.
  5. Tube rotation or manipulation, 0 if no rotation required, 1 if rotation required
  6. Airway trauma, 0 no trauma, 1 if minor injury (lip), 2 if oro-pharyngeal injury/ bleeding. 3, bleeding requiring use of suction
  7. Stress response based on heart rate and blood pressure (0 if stable, 1 if increased more than 20%)
  8. Overall patients' tolerance as judged by the Anaesthetists (visual analogue score of 0 to 100mm)
  9. Overall impression from patient on a visual analogue scale (visual analogue score of 0 to 100mm)
Being tested
Flexible fibreoptic scope, Pentax AWS videolaryngoscope

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Flexible fibreoptic scopeDevice

    Patient intubated using fibreoptic scope

  • Pentax AWS videolaryngoscopeDevice

    Patient intubated using Pentax AWS videolaryngoscope

Study groups in NCT02614924
Study groupRoleWhat they receive
Flexible fibre-optic scopeOtherRandomly allocated to fibreoptic group
Receives: Device: Flexible fibreoptic scope; Device: Pentax AWS videolaryngoscope
Pentax AWS videolaryngoscopeOtherRandomly allocated Pentax AWS videolaryngoscope
Receives: Device: Flexible fibreoptic scope; Device: Pentax AWS videolaryngoscope

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total Time Taken to Complete the Procedure of Awake Intubation

    Measured: up to 20 minutes

Secondary outcomes (1)
  1. Intubation Time

    Measured: up to 10 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2015 (estimated)
  2. Study startNov 2012
  3. Primary completionJul 2014
  4. Study completionJul 2014

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02614924
Sponsor's protocol ID
RD098211
Status last verified
Jul 2016
First submitted
24 Nov 2015
Last updated
22 Aug 2016
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Flexible fibreoptic scope and Pentax AWS videolaryngoscope in people with Anesthesia Intubation Complication, run by University Hospitals Coventry and Warwickshire NHS Trust.

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 2 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 22 Aug 2016. 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?

Yes. Results are posted in the registry (first posted 22 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Total Time Taken to Complete the Procedure of Awake Intubation (time frame: up to 20 minutes). 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 22 Aug 2016.

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