NCT02663843

Brief Summary

Tracheal intubation under general anaesthesia is the gold standard for securing the airway and for protecting the lungs against gastric aspiration. The conventional technique involves the use of a metal laryngoscope inserted into the mouth to create an air space, to allow insertion of an endotracheal tube. Alternatively, an oral airway device (called a supraglottic device (SGD)) can be used for tracheal intubation. The SGD is first inserted. A fibrescope is inserted down the shaft of the SGD and into the trachea. This allows an endotracheal tube (previously pre-loaded onto the fibrescope) to be railroaded of the fibrescope and into the trachea. This technique is called 'low skill fibreoptic intubation' as the SGD acts as a guide for the fibrescope. Our study compares the performance of two SGD: i-gel and air-Q. The investigators will compare intubation success rate, insertion rate, and times for SGD insertion and intubation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

January 18, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 26, 2016

Completed
11 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

May 1, 2017

Status Verified

April 1, 2017

Enrollment Period

5 months

First QC Date

January 18, 2016

Last Update Submit

April 27, 2017

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Success of low skill fibreoptic intubation using the i-gel or air-Q airway devices measured end tidal carbon dioxide levels

    Successful intubation indicated by normal end tidal carbon dioxide levels and trace

    3 minutes

Secondary Outcomes (3)

  • Airway device insertion times

    3 minutes

  • Low skill fibreoptic intubation times

    3 minutes

  • Complication rate

    Time of intubation and up to one day postoperative recovery period

Study Arms (2)

i-gel airway

EXPERIMENTAL

I-gel inserted for the low skill fibreoptic intubation technique

Device: i-gel airway

air-Q airway

EXPERIMENTAL

Air-Q inserted for the low skill fibreoptic intubation technique

Device: air-Q airway

Interventions

i-gel airwayDEVICE

Fibreoptic intubation via i-gel airway device

i-gel airway
air-Q airwayDEVICE

Fibreoptic intubation via air-Q airway device

air-Q airway

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with a physical status of American Society of Anesthesiologists (ASA) grade I/II and over 21 years old, having elective surgery, who require endotracheal intubation

You may not qualify if:

  • ASA class III/IV
  • Patients with history of previous difficult endotracheal intubation
  • Patients with two or more predictors of difficult airway management (criteria 1-8, below)
  • Airway masses
  • Mallampati (oropharygneal space grading) III or IV
  • Thyromental distance \< 6.5cm
  • Inter-incisor distance \< 3 cm
  • Head extension \< 30 degrees
  • Edentulous
  • Large beard
  • Obstructive sleep apnoea (OSA) or snorer
  • Patients needing a rapid sequence induction
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore General Hospitals

Singapore, 169608, Singapore

RECRUITING

Related Publications (3)

  • de Lloyd LJ, Subash F, Wilkes AR, Hodzovic I. A comparison of fibreoptic-guided tracheal intubation through the Ambu (R) Aura-i , the intubating laryngeal mask airway and the i-gel : a manikin study. Anaesthesia. 2015 May;70(5):591-7. doi: 10.1111/anae.12988. Epub 2015 Jan 29.

    PMID: 25631299BACKGROUND

  • Galgon RE, Schroeder KM, Han S, Andrei A, Joffe AM. The air-Q((R)) intubating laryngeal airway vs the LMA-ProSeal(TM) : a prospective, randomised trial of airway seal pressure. Anaesthesia. 2011 Dec;66(12):1093-100. doi: 10.1111/j.1365-2044.2011.06863.x. Epub 2011 Aug 22.

    PMID: 21880031BACKGROUND

  • Moon HS, Lee JY, Chon JY, Lee H, Kim D. Air-Q(R)sp-assisted awake fiberoptic bronchoscopic intubation in a patient with Ludwig's angina. Korean J Anesthesiol. 2014 Dec;67(Suppl):S23-4. doi: 10.4097/kjae.2014.67.S.S23. No abstract available.

    PMID: 25598892BACKGROUND

Study Officials

  • Patrick Wong, Patrick

    Singapore General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick Wong, MBBS FRCA

CONTACT

+6563214220Patrick.Wong@singhealth.com.sg

Hairil RB Abdullah, MBBS MMED

CONTACT

+6563214220hairil.rizal.abdullah@singhealth.com.sg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2016

First Posted

January 26, 2016

Study Start

January 1, 2017

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

May 1, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)