Intubation; Difficult or FailedNCT03118596

Fibre-optic Guided Tracheal Intubation Through SADs

A study testing I-gel and LMA Protector in people with Intubation; Difficult or Failed and Laryngeal Masks, run by University Hospitals Coventry and Warwickshire NHS Trust at 2 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Intubation; Difficult or Failed, Laryngeal Masks, Airway Management
What is being tested?: I-gel and LMA Protector
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 180 participants
Where: 2 sitesUnited Kingdom
Study dates: 24 May 2017to 26 Mar 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

University Hospitals Coventry & Warwickshire NHS Trust
Coventry, West Midlands, CV2 2DX
Oxford University Hospitals
Oxford, OX3 7LE

Other trials in United Kingdom

About this study

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

Read the 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.

Conditions: Intubation; Difficult or Failed, Laryngeal Masks, Airway Management
Being tested: I-gel, LMA Protector
Keywords: intubation, tracheal, airway device, supra-glottic airway device, fibreoptic scope

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT03118596
Study group	Role	What they receive
I-gel	Active comparator	Fibreoptic guided tracheal intubation through I-gel Receives: Device: I-gel
LMA Protector	Active comparator	Fibreoptic guided tracheal intubation through Protector Receives: Device: LMA Protector

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (7)

SAD Insertion Time
Time taken to insert the supra-glottic airway device measured from insertion into the mouth until the capnography trace is obtained
Measured: less than 1 minute
Number of Attempts at the SAD Placement
Number of attempts taken to successfully place the supraglottic airway device in the oropharynx
Measured: less than 2 minutes
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:
1. - Easy
2. - Moderate Difficulty 3- Severe Difficulty
4 - Failure
Measured: less than 2 minutes
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.
Measured: less than 3 minutes
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)
Measured: less than 3 minutes
Time to Carinal View
The time from insertion of fibreoptic scope into the lumen of the SAD to the visualization of the carina.
Measured: less than 1 minute
Number of Participants With Type of Airway Maneuvers Performed During Tracheal Intubation,
The number of tube rotations performed during tracheal intubation
Measured: less than 3 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 May 201726 Mar 2018

First posted18 Apr 2017
Study start24 May 2017
Primary completion26 Mar 2018
Study completion26 Mar 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Intubation; Difficult or FailedStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 180 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03118596
Sponsor's protocol ID: UHCoventryNHS
Status last verified: Mar 2020
First submitted: 13 Apr 2017
Last updated: 9 Apr 2020
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 26556848
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.
PubMed 21652616
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.
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.
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.
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.
PubMed 25537736
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.
PubMed 22050948
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. No abstract available.
PubMed 23860341
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. doi: 10.1177/0310057X1103900106.
PubMed 21375088

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Can the "Face Index"; an Anthropometric Measurement, Predict Difficult Laryngoscopy and Intubation?
Anesthesia Intubation Complication, Laryngoscopy
RecruitingObservational study
PrediSuisse: Automatized Assessment of Difficult Airway
Anesthesia, Intubation; Difficult or Failed
RecruitingObservational study
Difficult Airway Prediction by Integrating STOP-BANG Criteria
Ventilatory Defect, Intubation; Difficult or Failed
RecruitingObservational study
Improving Safety and Quality of Tracheal Intubation Practice in Pediatric ICUs
Failed or Difficult Intubation, Sequela, Intubation; Difficult
Active, not recruitingObservational study
Data-driven Development of a Core Dataset for Difficult Airway Alerts
Airway Management, Intubation; Difficult or Failed

All Intubation; Difficult or Failed trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Fibre-optic Guided Tracheal Intubation Through Supraglottic Airway Devices - a Randomised Comparison Between I-gel and the LMA ProtectorTM
ClinicalTrials.gov ID: NCT03118596
Acronym / sponsor ID: UHCoventryNHS
Conditions: Intubation; Difficult or Failed, Laryngeal Masks, Airway Management
Keywords: intubation, tracheal, airway device, supra-glottic airway device, fibreoptic scope
Study type: Interventional
Recruitment status: Completed
Enrolment: 180 participants (actual)
Lead sponsor: University Hospitals Coventry and Warwickshire NHS TrustUniversity, hospital or other
Study start: 24 May 2017 (actual)
Primary completion: 26 Mar 2018 (actual)
Study completion: 26 Mar 2018 (actual)
First posted: 18 Apr 2017 (actual)
Results: Posted 10 Oct 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
I-gel	Active comparator	Device: I-gelFibreoptic guided tracheal intubation through I-gel
LMA Protector	Active comparator	Device: LMA ProtectorFibreoptic guided tracheal intubation through Protector

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
I-gelFibreoptic guided tracheal intubation is going to be performed through the I-gel supraglottic airway.	Device	I-gel
LMA ProtectorFibreoptic guided tracheal intubation is going to be performed through the LMA Protector supraglottic airway.	Device	LMA Protector

Primary outcome

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

7 secondary outcomes

SAD Insertion Time
Time frame: less than 1 minute
Number of Attempts at the SAD Placement
Time frame: less than 2 minutes
Number of Participants With Ease of Placement of the SAD
Time frame: less than 2 minutes
Number of Participants With First and Second Attempt at Tracheal Intubation
Time frame: less than 3 minutes
Number of Participants With Quality of the View of the Vocal Cords Seen Through the SAD
Time frame: less than 3 minutes
Time to Carinal View
Time frame: less than 1 minute
Number of Participants With Type of Airway Maneuvers Performed During Tracheal Intubation,
Time frame: less than 3 minutes

Results and safety

Results posted to the registry on 10 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
I-gel	90	90
LMA Protector	90	86

Primary outcome: Total Intubation Time to Perform Fibreoptic Intubation

Time frame: less than 3 minutes. Mean (Standard Deviation). Unit: seconds

Measure	I-gel n = 92	LMA Protector n = 86
Value	54.3 (13.8)	52.0 (13)

Population analysed: 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

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 year. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
I-gel	0 of 92 (0%)	0 of 92 (0%)	0 of 92
LMA Protector	0 of 86 (0%)	0 of 86 (0%)	0 of 86

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 26556848Frerk 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.
Background: PubMed 21652616Kleine-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.
BackgroundEl-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.
BackgroundTaxak, 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.
BackgroundSamir, 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.
Background: PubMed 25537736Jagannathan 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.
Background: PubMed 22050948Weingart 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.
Background: PubMed 23860341Du 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. No abstract available.
Background: PubMed 21375088Joffe 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. doi: 10.1177/0310057X1103900106.
Individual participant dataSharing planned: No

Related trials for Intubation; Difficult or Failed

Not yet recruitingObservational study
Can the "Face Index"; an Anthropometric Measurement, Predict Difficult Laryngoscopy and Intubation?
Anesthesia Intubation Complication, Laryngoscopy
RecruitingObservational study
PrediSuisse: Automatized Assessment of Difficult Airway
Anesthesia, Intubation; Difficult or Failed
RecruitingObservational study
Difficult Airway Prediction by Integrating STOP-BANG Criteria
Ventilatory Defect, Intubation; Difficult or Failed
RecruitingObservational study
Improving Safety and Quality of Tracheal Intubation Practice in Pediatric ICUs
Failed or Difficult Intubation, Sequela, Intubation; Difficult
Active, not recruitingObservational study
Data-driven Development of a Core Dataset for Difficult Airway Alerts
Airway Management, Intubation; Difficult or Failed

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Cyprian Mendonca, Prof. principal investigator

University Hospitals Coventry & Warwickshire NHS Trust, Clifford Bridge Road, Coventry CV2 2DX

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Intubation Time to Perform Fibreoptic Intubation (time frame: less than 3 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03118596, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2020.