Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Low Skill Fibreoptic Intubation I-gel vs Air-Q

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02663843
Recruitment Status : Unknown
Verified April 2017 by Singapore General Hospital.
Recruitment status was:  Recruiting
First Posted : January 26, 2016
Last Update Posted : May 1, 2017
Sponsor:
Information provided by (Responsible Party):
Singapore General Hospital

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.


Condition or disease Intervention/treatment Phase
Anesthesia Device: i-gel airway Device: air-Q airway Not Applicable

Detailed Description:

The investigators are testing to see if fibreoptic intubation in patients via a supraglottic airway device i.e. 'low skill fibreoptic intubation' (LSFOI) is more successful via the i-gel® than in the air-Q®. Patients are those scheduled for elective surgery under general anaesthesia who would normally require tracheal intubation. The investigator's hypothesis is based on the results of the investigator's recent manikin study (CIRB 2014/2039). The investigators would like to see if this hypothesis translates to patients. It will also test secondary outcomes e.g. SGD insertion success rates and times, and intubation times. In the aforementioned manikin study, the air-Q® performed better with the SGD insertion rates and times. However, the i-gel® performed better with intubation success rates and times. The devices may perform different due to differences between the devices: design (shape, volume, length, aperture), material composition, and technique required for insertion and intubation.

24 adult patients undergoing elective surgery requiring general anaesthesia and endotracheal intubation in the major operating theater of Singapore General Hospital will be enrolled. The patient will then be randomised in equal proportions into two groups, either the air-Q® or i-gel®. Patients will undergo induction of general anaesthesia in a standardised fashion and in accordance with usual practice in the investigator's department of anaesthesia. Intubation will then proceed with the assigned airway device. Data collected will include successful endotracheal intubation, as evidenced by the presence of end tidal carbon dioxide on a capnograph. Time to intubation (from the initial handling of the airway device until successful intubation is confirmed with successful lung ventilation), the number of attempts required and the view achieved (according to the modified Cormack and Lehane scoring system) will also be recorded. Injuries to the lips, teeth or upper airway will be sought and documented by a blinded observer in the Post Anesthetic Care Unit.

A protocol will be provided to standardise the induction of general anaesthesia. This will involve the application of standard patient monitors, a period of pre-oxygenation, and administration of anaesthetic agents and muscle relaxants. If the patient desaturates to SpO2 < 94% during intubation, the intubation attempt via either the air-Q® or i-gel® will be abandoned and intubation will proceed using the conventional direct laryngoscope.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of 'Low Skill Fibreoptic Tracheal Intubation' Via I-gel® and Air-Q® Supraglottic Airway Devices in Patients With Simulated Difficult Airways.
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : June 1, 2017
Estimated Study Completion Date : June 1, 2017

Arm Intervention/treatment
Experimental: i-gel airway
I-gel inserted for the low skill fibreoptic intubation technique
Device: i-gel airway
Fibreoptic intubation via i-gel airway device

Experimental: air-Q airway
Air-Q inserted for the low skill fibreoptic intubation technique
Device: air-Q airway
Fibreoptic intubation via air-Q airway device




Primary Outcome Measures :
  1. Success of low skill fibreoptic intubation using the i-gel or air-Q airway devices measured end tidal carbon dioxide levels [ Time Frame: 3 minutes ]
    Successful intubation indicated by normal end tidal carbon dioxide levels and trace


Secondary Outcome Measures :
  1. Airway device insertion times [ Time Frame: 3 minutes ]
    Time from picking up device to obtaining adequate canpography tracing

  2. Low skill fibreoptic intubation times [ Time Frame: 3 minutes ]
    Time from picking up fibrescope to obtaining adequate canpography tracing

  3. Complication rate [ Time Frame: Time of intubation and up to one day postoperative recovery period ]
    Complications due to airway and fiberscope insertion and use



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

    1. Airway masses
    2. Mallampati (oropharygneal space grading) III or IV
    3. Thyromental distance < 6.5cm
    4. Inter-incisor distance < 3 cm
    5. Head extension < 30 degrees
    6. Edentulous
    7. Large beard
    8. Obstructive sleep apnoea (OSA) or snorer
  • Patients needing a rapid sequence induction
  • Pregnant women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02663843


Contacts
Layout table for location contacts
Contact: Patrick Wong, MBBS FRCA +6563214220 Patrick.Wong@singhealth.com.sg
Contact: Hairil RB Abdullah, MBBS MMED +6563214220 hairil.rizal.abdullah@singhealth.com.sg

Locations
Layout table for location information
Singapore
Singapore General Hospitals Recruiting
Singapore, Singapore, 169608
Contact: Patrick Wong, FRCA    63214220    patrick.wong@singhealth.com.sg   
Sponsors and Collaborators
Singapore General Hospital
Investigators
Layout table for investigator information
Principal Investigator: Patrick Wong, Patrick Singapore General Hospital