Fibre-optic Guided Tracheal Intubation Through SADs

NCT ID: NCT03118596

Last Updated: 2020-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-24
• Study Completion Date: 2018-03-26

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

I-gel

Fibreoptic guided tracheal intubation through I-gel

Group Type: ACTIVE_COMPARATOR

I-gel

Intervention Type: DEVICE

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

LMA Protector

Fibreoptic guided tracheal intubation through Protector

Group Type: ACTIVE_COMPARATOR

LMA Protector

Intervention Type: DEVICE

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

Interventions

I-gel

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

Intervention Type: DEVICE

LMA Protector

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospitals Coventry and Warwickshire NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cyprian Mendonca, Prof.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

University Hospitals Coventry & Warwickshire NHS Trust

Coventry, West Midlands, United Kingdom

Oxford University Hospitals

Oxford, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 26556848 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21652616 (View on PubMed)

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 25537736 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22050948 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23860341 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21375088 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

UHCoventryNHS

Identifier Type: -

Identifier Source: org_study_id