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Fibre-optic Guided Tracheal Intubation Through SADs

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ClinicalTrials.gov Identifier: NCT03118596
Recruitment Status : Completed
First Posted : April 18, 2017
Results First Posted : October 10, 2019
Last Update Posted : April 9, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospitals Coventry and Warwickshire NHS Trust

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.

Condition or disease Intervention/treatment Phase
Intubation; Difficult or Failed Laryngeal Masks Airway Management Device: I-gel Device: LMA Protector Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Fibre-optic Guided Tracheal Intubation Through Supraglottic Airway Devices - a Randomised Comparison Between I-gel and the LMA ProtectorTM
Actual Study Start Date : May 24, 2017
Actual Primary Completion Date : March 26, 2018
Actual Study Completion Date : March 26, 2018

Arm Intervention/treatment
Active Comparator: I-gel
Fibreoptic guided tracheal intubation through I-gel
Device: I-gel
Fibreoptic guided tracheal intubation is going to be performed through the I-gel supraglottic airway.

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. SAD Insertion Time [ Time Frame: less than 1 minute ]
    Time taken to insert the supra-glottic airway device measured from insertion into the mouth until the capnography trace is obtained

  2. Number of Attempts at the SAD Placement [ Time Frame: less than 2 minutes ]
    Number of attempts taken to successfully place the supraglottic airway device in the oropharynx

  3. Number of Participants With Ease of Placement of the SAD [ Time Frame: less than 2 minutes ]

    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


  4. Number of Participants With First and Second Attempt at Tracheal Intubation [ Time Frame: less than 3 minutes ]
    Number of attempts at tracheal intubation. A new attempt is defined as re-insertion of the fibreoptic bronchoscope through the SAD.

  5. Number of Participants With Quality of the View of the Vocal Cords Seen Through the SAD [ Time Frame: less than 3 minutes ]
    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)

  6. Time to Carinal View [ Time Frame: less than 1 minute ]
    The time from insertion of fibreoptic scope into the lumen of the SAD to the visualization of the carina.

  7. Number of Participants With Type of Airway Maneuvers Performed During Tracheal Intubation, [ Time Frame: less than 3 minutes ]
    The number of tube rotations performed during tracheal intubation



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT03118596


Locations
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United Kingdom
University Hospitals Coventry & Warwickshire NHS Trust
Coventry, West Midlands, United Kingdom, CV2 2DX
Oxford University Hospitals
Oxford, United Kingdom, OX3 7LE
Sponsors and Collaborators
University Hospitals Coventry and Warwickshire NHS Trust
Investigators
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Principal Investigator: Cyprian Mendonca, Prof. University Hospitals Coventry & Warwickshire NHS Trust, Clifford Bridge Road, Coventry CV2 2DX
  Study Documents (Full-Text)

Documents provided by University Hospitals Coventry and Warwickshire NHS Trust:
Publications:
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.

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Responsible Party: University Hospitals Coventry and Warwickshire NHS Trust
ClinicalTrials.gov Identifier: NCT03118596    
Other Study ID Numbers: UHCoventryNHS
First Posted: April 18, 2017    Key Record Dates
Results First Posted: October 10, 2019
Last Update Posted: April 9, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospitals Coventry and Warwickshire NHS Trust:
intubation
tracheal
airway device
supra-glottic airway device
fibreoptic scope