Fibre-optic Guided Tracheal Intubation Through SADs

• Sponsor: University Hospitals Coventry and Warwickshire NHS Trust (Other)
• Overall Status: Completed
• CT.gov ID: NCT03118596
• Collaborator: (none)
• Enrollment: 180
• Locations: 2
• Arms: 2
• Actual Duration (Months): 10.1
• Patients Per Site: 90
• Patients Per Site Per Month: 9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intubation; Difficult or Failed; Laryngeal Masks; Airway Management	Device: I-gel; Device: LMA Protector	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 180 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• 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: Mar 26, 2018
• Actual Study Completion Date: Mar 26, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: I-gel Fibreoptic guided tracheal intubation through I-gel	Device: 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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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

3. 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: - Easy - Moderate Difficulty 3- Severe Difficulty 4 - Failure

4. 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.

5. 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)

6. 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.

7. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospitals Coventry & Warwickshire NHS Trust	Coventry	West Midlands	United Kingdom	CV2 2DX
2	Oxford University Hospitals	Oxford		United Kingdom	OX3 7LE

Sponsors and Collaborators

• University Hospitals Coventry and Warwickshire NHS Trust

Investigators

• Principal Investigator: Cyprian Mendonca, Prof., University Hospitals Coventry & Warwickshire NHS Trust, Clifford Bridge Road, Coventry CV2 2DX

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 28, 2017

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: University Hospitals Coventry and Warwickshire NHS Trust
• ClinicalTrials.gov Identifier: NCT03118596
• Other Study ID Numbers: UHCoventryNHS
• First Posted: Apr 18, 2017
• Last Update Posted: Apr 9, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospitals Coventry and Warwickshire NHS Trust: intubation; tracheal; airway device; supra-glottic airway device; fibreoptic scope

Study Results

Participant Flow

Arm/Group Title	I-gel	LMA Protector
Arm/Group Description	Fibreoptic guided tracheal intubation through I-gel I-gel: Fibreoptic guided tracheal intubation is going to be performed through the I-gel supraglottic airway.	Fibreoptic guided tracheal intubation through Protector LMA Protector: Fibreoptic guided tracheal intubation is going to be performed through the LMA Protector supraglottic airway.
Period Title: Overall Study
STARTED	90	90
Treated	2	0
Failed	0	4
COMPLETED	90	86
NOT COMPLETED	0	4

Baseline Characteristics

Arm/Group Title	I-gel	LMA Protector	Total
Arm/Group Description	Fibreoptic guided tracheal intubation through I-gel I-gel: Fibreoptic guided tracheal intubation is going to be performed through the I-gel supraglottic airway.	Fibreoptic guided tracheal intubation through Protector LMA Protector: Fibreoptic guided tracheal intubation is going to be performed through the LMA Protector supraglottic airway.	Total of all reporting groups
Overall Participants	90	86	176
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	57 63.3%	55 64%	112 63.6%
>=65 years	33 36.7%	31 36%	64 36.4%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.7 (15)	54.7 (17)	55 (15)
Sex: Female, Male (Count of Participants)
Female	39 43.3%	35 40.7%	74 42%
Male	51 56.7%	51 59.3%	102 58%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United Kingdom	90 100%	86 100%	176 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

In 2 patients randomly allocated to the LMA Protector group due to the failure insertion of the LMA protector the i-gel was used instead. 2 patients randomised to the LMA protector group underwent direct laryngoscopy and tracheal intubation; one due to failed insertion of both devices and one due to the failed fibreopitc-guided tracheal intubation

Arm/Group Title	I-gel	LMA Protector
Arm/Group Description	Fibreoptic guided tracheal intubation through I-gel I-gel: Fibreoptic guided tracheal intubation is going to be performed through the I-gel supraglottic airway.	Fibreoptic guided tracheal intubation through Protector LMA Protector: Fibreoptic guided tracheal intubation is going to be performed through the LMA Protector supraglottic airway.
Measure Participants	92	86
Mean (Standard Deviation) [seconds]	54.3 (13.8)	52.0 (13)

2. Secondary Outcome

Title	SAD Insertion Time
Description	Time taken to insert the supra-glottic airway device measured from insertion into the mouth until the capnography trace is obtained
Time Frame	less than 1 minute

Outcome Measure Data

Analysis Population Description

In 2 patients randomly allocated to the LMA Protector group due to the failure insertion of the LMA protector the i-gel was used instead. 2 patients randomised to the LMA protector group underwent direct laryngoscopy and tracheal intubation; one due to failed insertion of both devices and one due to the failed fibreopitc-guided tracheal intubation

Arm/Group Title	I-gel	LMA Protector
Arm/Group Description	Fibreoptic guided tracheal intubation through I-gel I-gel: Fibreoptic guided tracheal intubation is going to be performed through the I-gel supraglottic airway.	Fibreoptic guided tracheal intubation through Protector LMA Protector: Fibreoptic guided tracheal intubation is going to be performed through the LMA Protector supraglottic airway.
Measure Participants	92	86
Mean (Standard Deviation) [seconds]	19.4 (5.6)	25.4 (7.9)

3. Secondary Outcome

Title	Number of Attempts at the SAD Placement
Description	Number of attempts taken to successfully place the supraglottic airway device in the oropharynx
Time Frame	less than 2 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Number of Participants With Ease of Placement of the SAD
Description	The ease of placement of the SAD assessed by the investigator on a four point scale: - Easy - Moderate Difficulty 3- Severe Difficulty 4 - Failure
Time Frame	less than 2 minutes

Outcome Measure Data

Analysis Population Description

In 2 patients randomly allocated to the LMA Protector group due to the failure insertion of the LMA protector the i-gel was used instead. 2 patients randomised to the LMA protector group underwent direct laryngoscopy and tracheal intubation; one due to failed insertion of both devices and one due to the failed fibreopitc-guided tracheal intubation

Arm/Group Title	I-gel	LMA Protector
Arm/Group Description	Fibreoptic guided tracheal intubation through I-gel I-gel: Fibreoptic guided tracheal intubation is going to be performed through the I-gel supraglottic airway.	Fibreoptic guided tracheal intubation through Protector LMA Protector: Fibreoptic guided tracheal intubation is going to be performed through the LMA Protector supraglottic airway.
Measure Participants	92	86
Easy	86 95.6%	37 43%
Moderate Resistance	6 6.7%	44 51.2%
Severe Resistance	0 0%	5 5.8%
Failure	0 0%	0 0%

5. Secondary Outcome

Title	Number of Participants With First and Second Attempt at Tracheal Intubation
Description	Number of attempts at tracheal intubation. A new attempt is defined as re-insertion of the fibreoptic bronchoscope through the SAD.
Time Frame	less than 3 minutes

Outcome Measure Data

Analysis Population Description

IIn 2 patients randomly allocated to the LMA Protector group due to the failure insertion of the LMA protector the i-gel was used instead. 2 patients randomised to the LMA protector group underwent direct laryngoscopy and tracheal intubation; one due to failed insertion of both devices and one due to the failed fibreopitc-guided tracheal intubation

Arm/Group Title	I-gel	LMA Protector
Arm/Group Description	Fibreoptic guided tracheal intubation through I-gel I-gel: Fibreoptic guided tracheal intubation is going to be performed through the I-gel supraglottic airway.	Fibreoptic guided tracheal intubation through Protector LMA Protector: Fibreoptic guided tracheal intubation is going to be performed through the LMA Protector supraglottic airway.
Measure Participants	92	86
First Attempt	90 100%	84 97.7%
Second Attempt	2 2.2%	2 2.3%

6. Secondary Outcome

Title	Number of Participants With Quality of the View of the Vocal Cords Seen Through the SAD
Description	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 Frame	less than 3 minutes

Outcome Measure Data

Analysis Population Description

In 2 patients randomly allocated to the LMA Protector group due to the failure insertion of the LMA protector the i-gel was used instead. 2 patients randomised to the LMA protector group underwent direct laryngoscopy and tracheal intubation; one due to failed insertion of both devices and one due to the failed fibreopitc-guided tracheal intubation

Arm/Group Title	I-gel	LMA Protector
Arm/Group Description	Fibreoptic guided tracheal intubation through I-gel I-gel: Fibreoptic guided tracheal intubation is going to be performed through the I-gel supraglottic airway.	Fibreoptic guided tracheal intubation through Protector LMA Protector: Fibreoptic guided tracheal intubation is going to be performed through the LMA Protector supraglottic airway.
Measure Participants	92	86
Grade 1	71 78.9%	72 83.7%
Grade 2	20 22.2%	14 16.3%
Grade 3	1 1.1%	0 0%

7. Secondary Outcome

Title	Time to Carinal View
Description	The time from insertion of fibreoptic scope into the lumen of the SAD to the visualization of the carina.
Time Frame	less than 1 minute

Outcome Measure Data

Analysis Population Description

In 2 patients randomly allocated to the LMA Protector group due to the failure insertion of the LMA protector the i-gel was used instead. 2 patients randomised to the LMA protector group underwent direct laryngoscopy and tracheal intubation; one due to failed insertion of both devices and one due to the failed fibreopitc-guided tracheal intubation

Arm/Group Title	I-gel	LMA Protector
Arm/Group Description	Fibreoptic guided tracheal intubation through I-gel I-gel: Fibreoptic guided tracheal intubation is going to be performed through the I-gel supraglottic airway.	Fibreoptic guided tracheal intubation through Protector LMA Protector: Fibreoptic guided tracheal intubation is going to be performed through the LMA Protector supraglottic airway.
Measure Participants	92	86
Mean (Standard Deviation) [seconds]	23.4 (10)	21.9 (8.3)

8. Secondary Outcome

Title	Number of Participants With Type of Airway Maneuvers Performed During Tracheal Intubation,
Description	The number of tube rotations performed during tracheal intubation
Time Frame	less than 3 minutes

Outcome Measure Data

Analysis Population Description

In 2 patients randomly allocated to the LMA Protector group due to the failure insertion of the LMA protector the i-gel was used instead. 2 patients randomised to the LMA protector group underwent direct laryngoscopy and tracheal intubation; one due to failed insertion of both devices and one due to the failed fibreopitc-guided tracheal intubation

Arm/Group Title	I-gel	LMA Protector
Arm/Group Description	Fibreoptic guided tracheal intubation through I-gel I-gel: Fibreoptic guided tracheal intubation is going to be performed through the I-gel supraglottic airway.	Fibreoptic guided tracheal intubation through Protector LMA Protector: Fibreoptic guided tracheal intubation is going to be performed through the LMA Protector supraglottic airway.
Measure Participants	92	86
Tube impingement (Yes)	38 42.2%	23 26.7%
Tube impingement (No)	54 60%	63 73.3%

Adverse Events

Time Frame	1 year
Adverse Event Reporting Description	In two patients randomly allocated to the LMA protector group, due to failed insertion of LMA protector the I-GEL was used instead In two patients allocated to the LMA protector group, due to failed intubation direct laryngoscopy was performed. Therefore; the final number in I-GEL group is 92 and LMA Protector Group is 86(2 were allocated to I-GEL and 2 completely failed)
Arm/Group Title	I-gel		LMA Protector
Arm/Group Description	Fibreoptic guided tracheal intubation through I-gel I-gel: Fibreoptic guided tracheal intubation is going to be performed through the I-gel supraglottic airway.		Fibreoptic guided tracheal intubation through Protector LMA Protector: Fibreoptic guided tracheal intubation is going to be performed through the LMA Protector supraglottic airway.
All Cause Mortality
	I-gel		LMA Protector
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/92 (0%)		0/86 (0%)
Serious Adverse Events
	I-gel		LMA Protector
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/92 (0%)		0/86 (0%)
Other (Not Including Serious) Adverse Events
	I-gel		LMA Protector
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/92 (0%)		0/86 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.