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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02614924
Enrollment
40
Registered
2015-11-25
Start date
2012-11-30
Completion date
2014-07-31
Last updated
2016-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia Intubation Complication

Brief 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.

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)

Interventions

DEVICEFlexible fibreoptic scope

Patient intubated using fibreoptic scope

Patient intubated using Pentax AWS videolaryngoscope

Sponsors

University Hospitals Coventry and Warwickshire NHS Trust
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Total Time Taken to Complete the Procedure of Awake Intubationup to 20 minutes

Secondary

MeasureTime frame
Intubation Timeup to 10 minutes

Participant flow

Recruitment details

Patients were recruited between 27.11.12 till 24.7.14. Recruitment was done during anaesthetic prep assessment.

Pre-assignment details

No participants were excluded

Participants by arm

ArmCount
Flexible Fibre-optic Scope
Randomly allocated to fibreoptic group Flexible fibreoptic scope: Patient intubated using fibreoptic scope
20
Pentax AWS Videolaryngoscope Group
Randomly allocated Pentax AWS videolaryngoscope and intubated using Pentax AWS videolaryngoscope
20
Total40

Baseline characteristics

CharacteristicPentax AWS Videolaryngoscope GroupTotalFlexible Fibre-optic Scope
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
11 Participants15 Participants4 Participants
Age, Categorical
Between 18 and 65 years
9 Participants25 Participants16 Participants
Age, Continuous66.5 years60.5 years55.5 years
Region of Enrollment
United Kingdom
20 participants40 participants20 participants
Sex: Female, Male
Female
12 Participants21 Participants9 Participants
Sex: Female, Male
Male
8 Participants19 Participants11 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 200 / 20
serious
Total, serious adverse events
0 / 200 / 20

Outcome results

Primary

Total Time Taken to Complete the Procedure of Awake Intubation

Time frame: up to 20 minutes

ArmMeasureValue (MEDIAN)
Flexible Fibre-optic ScopeTotal Time Taken to Complete the Procedure of Awake Intubation900 seconds
Pentax AWS VideolaryngoscopeTotal Time Taken to Complete the Procedure of Awake Intubation651 seconds
Secondary

Intubation Time

Time frame: up to 10 minutes

ArmMeasureValue (MEDIAN)
Flexible Fibre-optic ScopeIntubation Time420 seconds
Pentax AWS VideolaryngoscopeIntubation Time183 seconds

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026