Skip to main content
OpenTrials
Completed

NCT Number: NCT03118596

Fibre-optic Guided Tracheal Intubation Through SADs

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

I-gel

Device

Fibreoptic guided tracheal intubation is going to be performed through the I-gel supraglottic airway.

LMA Protector

Device

Fibreoptic guided tracheal intubation is going to be performed through the LMA Protector supraglottic airway.

Primary outcomes

  1. Total Intubation Time to Perform Fibreoptic Intubation

    Time frame: less than 3 minutes

    Time form insertion of bronchoscope through the supraglottic airway device to obtaining the capnography trace

Secondary outcomes

  1. SAD Insertion Time

    Time frame: 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

  2. Number of Attempts at the SAD Placement

    Time frame: less than 2 minutes

    Number of attempts taken to successfully place the supraglottic airway device in the oropharynx

  3. Number of Participants With Ease of Placement of the SAD

    Time frame: less than 2 minutes

    The ease of placement of the SAD assessed by the investigator on a four point scale:

    • - Easy
    • - Moderate Difficulty 3- Severe Difficulty

    4 - Failure

  4. Number of Participants With First and Second Attempt at Tracheal Intubation

    Time frame: 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.

  5. Number of Participants With Quality of the View of the Vocal Cords Seen Through the SAD

    Time frame: 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)

  6. Time to Carinal View

    Time frame: less than 1 minute

    The time from insertion of fibreoptic scope into the lumen of the SAD to the visualization of the carina.

  7. Number of Participants With Type of Airway Maneuvers Performed During Tracheal Intubation,

    Time frame: less than 3 minutes

    The number of tube rotations performed during tracheal intubation

Sponsors and collaborators

Lead sponsor

University Hospitals Coventry and Warwickshire NHS Trust

Other

Registry information

Official study title

Fibre-optic Guided Tracheal Intubation Through Supraglottic Airway Devices - a Randomised Comparison Between I-gel and the LMA ProtectorTM

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 18, 2017
Registry last updated
Apr 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.