NCT03118596

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 18, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

May 24, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2018

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

October 10, 2019

Completed
Last Updated

April 9, 2020

Status Verified

March 1, 2020

Enrollment Period

10 months

First QC Date

April 13, 2017

Results QC Date

August 15, 2018

Last Update Submit

March 27, 2020

Conditions

Intubation; Difficult or FailedLaryngeal MasksAirway Management

Keywords

intubationtrachealairway devicesupra-glottic airway devicefibreoptic scope

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • SAD Insertion Time

    less than 1 minute

  • Number of Attempts at the SAD Placement

    less than 2 minutes

  • Number of Participants With Ease of Placement of the SAD

    less than 2 minutes

  • Number of Participants With First and Second Attempt at Tracheal Intubation

    less than 3 minutes

  • Number of Participants With Quality of the View of the Vocal Cords Seen Through the SAD

    less than 3 minutes

  • +2 more secondary outcomes

Study Arms (2)

I-gel

ACTIVE COMPARATOR

Fibreoptic guided tracheal intubation through I-gel

Device: I-gel

LMA Protector

ACTIVE COMPARATOR

Fibreoptic guided tracheal intubation through Protector

Device: LMA Protector

Interventions

I-gelDEVICE

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

I-gel
LMA ProtectorDEVICE

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

LMA Protector

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospitals Coventry & Warwickshire NHS Trust

Coventry, West Midlands, CV2 2DX, United Kingdom

Location

Oxford University Hospitals

Oxford, OX3 7LE, United Kingdom

Location

Related Publications (9)

  • 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.

    PMID: 26556848BACKGROUND

  • 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.

    PMID: 21652616BACKGROUND

  • 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.

    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.

    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.

    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.

    PMID: 25537736BACKGROUND

  • 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.

    PMID: 22050948BACKGROUND

  • 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.

    PMID: 23860341BACKGROUND

  • 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.

    PMID: 21375088BACKGROUND

Results Point of Contact

Title
Dr Cyprian Mendonca
Organization
University Hospitals Coventry & Warwickshire NHS Trust
cyprian.mendonca@hotmail.com
02476964000

Study Officials

  • Cyprian Mendonca, Prof.

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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2017

First Posted

April 18, 2017

Study Start

May 24, 2017

Primary Completion

March 26, 2018

Study Completion

March 26, 2018

Last Updated

April 9, 2020

Results First Posted

October 10, 2019

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(2)