Fibre-optic Guided Tracheal Intubation Through SADs

Not Applicable

Completed

• Conditions: Intubation; Difficult or Failed; Laryngeal Masks; Airway Management
• Interventions: Device: LMA Protector; Device: I-gel

• Registration Number: NCT03118596
• Lead Sponsor: University Hospitals Coventry and Warwickshire NHS Trust

Brief Summary

The study aims to establish which of the two second generation Supraglottic Airway Devices, the I-gel or the the laryngeal ask airway (LMA) Protector, is best suited to be used as a conduit to fibreoptic bronchoscope assisted tracheal intubation. The primary outcome of this will be the time to complete the tracheal intubation.

Detailed Description

Tracheal intubation through a supraglottic airway device (SAD) is a well-established technique in the management of patients with a difficult airway. The technique can be used in patients in whom difficult intubation is expected, or in situations when tracheal intubation using another method was not possible. It is now recommended that tracheal intubation through the SAD should be performed using a fibreoptic scope (a camera device) to minimise the risk of trauma to the airway, and that second generation SADs are used to minimise the risk of aspiration of gastric contents.

There are two second generation SADs currently available which allow tracheal intubation: the I-gel and the LMA protector.

The I-gel is a second generation supraglottic airway device widely used in anaesthesia and resuscitation. Fibreoptic intubation through the I-gel has been evaluated in a recent prospective study (1), with the first attempt success rate of 91.4%. In another study (2) of patients with predicted difficult airway, the success rate of the procedure at first attempt was 96%.

LMA Protector is a recently introduced, improved version the LMA supreme - another second generation SAD. LMA supreme has been used in clinical practice for more than 10 years, however, tracheal intubation through the device was extremely difficult because of the small size of the breathing channel. The LMA Protector, has a larger breathing channel allowing the passage of an endotracheal tube. Compared to the I-gel, is has also got a larger gastric drainage tube. This allows easy suction in the event of regurgitation. Therefore, it appears to be superior to the I-gel in preventing the aspiration. But there are no studies comparing the ease of intubation through I-gel and LMA Protector

The aim of this study is to compare the ease of performing the fibreoptic guided tracheal intubation through these two devices. Our hypothesis is that intubation through the I-gel is easier and quicker.

Study Timeline

• Study First Submitted: 2017-04-13
• Study First Submitted QC: 2017-04-13
• Study First Posted: 2017-04-18
• Study Start: 2017-05-24
• Primary Completion: 2018-03-26
• Study Completion: 2018-03-26
• Results First Submitted: 2018-08-15
• Results First Submitted QC: 2019-09-20
• Results First Posted: 2019-10-10
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-27
• Last Update Posted: 2020-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• All patients aged above 18, presenting for elective surgical procedure, where a supraglottic airway device can be used and left in place throughout the duration of surgery and requiring tracheal intubation

Exclusion Criteria

• Patients who are do not wish to take part
• Patients with class II obesity (BMI >40)
• Patients below 18 years of age
• American Society of Anaesthesiologists (ASA 3, 4 and 5)
• Patients with mouth opening of less than 3 cm
• Patients deemed to require awake intubation
• Surgery involving head and neck region
• Surgery requiring prone position

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LMA Protector	LMA Protector	Fibreoptic guided tracheal intubation through Protector
I-gel	I-gel	Fibreoptic guided tracheal intubation through I-gel

Primary Outcome Measures

Name	Time	Method
Total Intubation Time to Perform Fibreoptic Intubation	less than 3 minutes	Time form insertion of bronchoscope through the supraglottic airway device to obtaining the capnography trace

Secondary Outcome Measures

Name	Time	Method
Number of Attempts at the SAD Placement	less than 2 minutes	Number of attempts taken to successfully place the supraglottic airway device in the oropharynx
Number of Participants With Ease of Placement of the SAD	less than 2 minutes	The ease of placement of the SAD assessed by the investigator on a four point scale: 1. - Easy; 2. - Moderate Difficulty 3- Severe Difficulty; 4 - Failure
Time to Carinal View	less than 1 minute	The time from insertion of fibreoptic scope into the lumen of the SAD to the visualization of the carina.
Number of Participants With Type of Airway Maneuvers Performed During Tracheal Intubation,	less than 3 minutes	The number of tube rotations performed during tracheal intubation
SAD Insertion Time	less than 1 minute	Time taken to insert the supra-glottic airway device measured from insertion into the mouth until the capnography trace is obtained
Number of Participants With First and Second Attempt at Tracheal Intubation	less than 3 minutes	Number of attempts at tracheal intubation. A new attempt is defined as re-insertion of the fibreoptic bronchoscope through the SAD.
Number of Participants With Quality of the View of the Vocal Cords Seen Through the SAD	less than 3 minutes	The quality of the view of the vocal cords seen through the SAD. It will be assessed, according to the previously published system, as: grade I - full view of the vocal cord, II - partial view of the vocal cords including arytenoids, III - epiglottis only, IV - other (SAD cuff, pharynx, others)

Trial Locations

Locations (2)

University Hospitals Coventry & Warwickshire NHS Trust; 🇬🇧 Coventry, West Midlands, United Kingdom

Oxford University Hospitals; 🇬🇧 Oxford, United Kingdom