Fibre-optic Guided Tracheal Intubation Through SADs
|ClinicalTrials.gov Identifier: NCT03118596|
Recruitment Status : Completed
First Posted : April 18, 2017
Results First Posted : October 10, 2019
Last Update Posted : April 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Intubation; Difficult or Failed Laryngeal Masks Airway Management||Device: I-gel Device: LMA Protector||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Fibre-optic Guided Tracheal Intubation Through Supraglottic Airway Devices - a Randomised Comparison Between I-gel and the LMA ProtectorTM|
|Actual Study Start Date :||May 24, 2017|
|Actual Primary Completion Date :||March 26, 2018|
|Actual Study Completion Date :||March 26, 2018|
Active Comparator: I-gel
Fibreoptic guided tracheal intubation through I-gel
Fibreoptic guided tracheal intubation is going to be performed through the I-gel supraglottic airway.
Active Comparator: LMA Protector
Fibreoptic guided tracheal intubation through Protector
Device: LMA Protector
Fibreoptic guided tracheal intubation is going to be performed through the LMA Protector supraglottic airway.
- 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
- 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
- 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
- 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
- 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.
- 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)
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03118596
|University Hospitals Coventry & Warwickshire NHS Trust|
|Coventry, West Midlands, United Kingdom, CV2 2DX|
|Oxford University Hospitals|
|Oxford, United Kingdom, OX3 7LE|
|Principal Investigator:||Cyprian Mendonca, Prof.||University Hospitals Coventry & Warwickshire NHS Trust, Clifford Bridge Road, Coventry CV2 2DX|