Fibre-optic Guided Tracheal Intubation Through SADs

Airway Management Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03118596
• Other study ID #: UHCoventryNHS
• Status: Completed
• Phase: N/A
• Start date: May 24, 2017
• Est. completion date: March 26, 2018

Study information

• Verified date: March 2020
• Source: University Hospitals Coventry and Warwickshire NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: March 26, 2018
• Est. primary completion date: March 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Airway Management
• Intubation; Difficult or Failed
• Laryngeal Masks

Intervention

Device:
• I-gel
Fibreoptic guided tracheal intubation is going to be performed through the I-gel supraglottic airway.
• LMA Protector
Fibreoptic guided tracheal intubation is going to be performed through the LMA Protector supraglottic airway.

Locations

Country	Name	City	State
United Kingdom	University Hospitals Coventry & Warwickshire NHS Trust	Coventry	West Midlands
United Kingdom	Oxford University Hospitals	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals Coventry and Warwickshire NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (9)

Du Rand IA, Blaikley J, Booton R, Chaudhuri N, Gupta V, Khalid S, Mandal S, Martin J, Mills J, Navani N, Rahman NM, Wrightson JM, Munavvar M; British Thoracic Society Bronchoscopy Guideline Group. British Thoracic Society guideline for diagnostic flexible bronchoscopy in adults: accredited by NICE. Thorax. 2013 Aug;68 Suppl 1:i1-i44. doi: 10.1136/thoraxjnl-2013-203618. — View Citation

El-Ganzouri, A. R., Marzouk, S., Abdelalem, N., & Yousef, M. (2011). Blind versus fiberoptic laryngoscopic intubation through air Q laryngeal mask airway. Egyptian Journal of Anaesthesia, 27(4), 213-218.

Frerk C, Mitchell VS, McNarry AF, Mendonca C, Bhagrath R, Patel A, O'Sullivan EP, Woodall NM, Ahmad I; Difficult Airway Society intubation guidelines working group. Difficult Airway Society 2015 guidelines for management of unanticipated difficult intubation in adults. Br J Anaesth. 2015 Dec;115(6):827-48. doi: 10.1093/bja/aev371. Epub 2015 Nov 10. — View Citation

Jagannathan N, Sohn L, Ramsey M, Huang A, Sawardekar A, Sequera-Ramos L, Kromrey L, De Oliveira GS. A randomized comparison between the i-gel™ and the air-Q™ supraglottic airways when used by anesthesiology trainees as conduits for tracheal intubation in children. Can J Anaesth. 2015 Jun;62(6):587-94. doi: 10.1007/s12630-014-0304-9. Epub 2014 Dec 24. — View Citation

Joffe AM, Liew EC, Galgon RE, Viernes D, Treggiari MM. The second-generation air-Q intubating laryngeal mask for airway maintenance during anaesthesia in adults: a report of the first 70 uses. Anaesth Intensive Care. 2011 Jan;39(1):40-5. — View Citation

Kleine-Brueggeney M, Theiler L, Urwyler N, Vogt A, Greif R. Randomized trial comparing the i-gel™ and Magill tracheal tube with the single-use ILMA™ and ILMA™ tracheal tube for fibreoptic-guided intubation in anaesthetized patients with a predicted difficult airway. Br J Anaesth. 2011 Aug;107(2):251-7. doi: 10.1093/bja/aer103. Epub 2011 Jun 7. — View Citation

Samir, E. M., & Sakr, S. A. (2012). The air-Q as a conduit for fiberoptic aided tracheal intubation in adult patients undergoing cervical spine fixation: A prospective randomized study. Egyptian Journal of Anaesthesia, 28(2), 133-137.

Taxak, S., Vashisht, K., Kaur, K. P., Ahlawat, G., & Bhardwaj, M. (2013). A study to evaluate fibreoptic-guided intubation through the i-gel. Southern African Journal of Anaesthesia and Analgesia, 19(2), 120-123.

Weingart SD, Levitan RM. Preoxygenation and prevention of desaturation during emergency airway management. Ann Emerg Med. 2012 Mar;59(3):165-75.e1. doi: 10.1016/j.annemergmed.2011.10.002. Epub 2011 Nov 3. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Intubation Time to Perform Fibreoptic Intubation	Time form insertion of bronchoscope through the supraglottic airway device to obtaining the capnography trace	less than 3 minutes
Secondary	SAD Insertion Time	Time taken to insert the supra-glottic airway device measured from insertion into the mouth until the capnography trace is obtained	less than 1 minute
Secondary	Number of Attempts at the SAD Placement	Number of attempts taken to successfully place the supraglottic airway device in the oropharynx	less than 2 minutes
Secondary	Number of Participants With Ease of Placement of the SAD	The ease of placement of the SAD assessed by the investigator on a four point scale: - Easy; - Moderate Difficulty 3- Severe Difficulty; 4 - Failure	less than 2 minutes
Secondary	Number of Participants With First and Second Attempt at Tracheal Intubation	Number of attempts at tracheal intubation. A new attempt is defined as re-insertion of the fibreoptic bronchoscope through the SAD.	less than 3 minutes
Secondary	Number of Participants With Quality of the View of the Vocal Cords Seen Through the SAD	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)	less than 3 minutes
Secondary	Time to Carinal View	The time from insertion of fibreoptic scope into the lumen of the SAD to the visualization of the carina.	less than 1 minute
Secondary	Number of Participants With Type of Airway Maneuvers Performed During Tracheal Intubation,	The number of tube rotations performed during tracheal intubation	less than 3 minutes