Airway Management Clinical Trial
Official title:
Fibre-optic Guided Tracheal Intubation Through Supraglottic Airway Devices - a Randomised Comparison Between I-gel and the LMA ProtectorTM
Verified date | March 2020 |
Source | University Hospitals Coventry and Warwickshire NHS Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 180 |
Est. completion date | March 26, 2018 |
Est. primary completion date | March 26, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University Hospitals Coventry & Warwickshire NHS Trust | Coventry | West Midlands |
United Kingdom | Oxford University Hospitals | Oxford |
Lead Sponsor | Collaborator |
---|---|
University Hospitals Coventry and Warwickshire NHS Trust |
United Kingdom,
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. — View Citation
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.
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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.
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.
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | SAD Insertion Time | Time taken to insert the supra-glottic airway device measured from insertion into the mouth until the capnography trace is obtained | less than 1 minute | |
Secondary | Number of Attempts at the SAD Placement | Number of attempts taken to successfully place the supraglottic airway device in the oropharynx | less than 2 minutes | |
Secondary | Number of Participants With Ease of Placement of the SAD | The ease of placement of the SAD assessed by the investigator on a four point scale: - Easy - Moderate Difficulty 3- Severe Difficulty 4 - Failure |
less than 2 minutes | |
Secondary | Number of Participants With First and Second Attempt at Tracheal Intubation | Number of attempts at tracheal intubation. A new attempt is defined as re-insertion of the fibreoptic bronchoscope through the SAD. | less than 3 minutes | |
Secondary | Number of Participants With Quality of the View of the Vocal Cords Seen Through the SAD | 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) | less than 3 minutes | |
Secondary | Time to Carinal View | The time from insertion of fibreoptic scope into the lumen of the SAD to the visualization of the carina. | less than 1 minute | |
Secondary | Number of Participants With Type of Airway Maneuvers Performed During Tracheal Intubation, | The number of tube rotations performed during tracheal intubation | less than 3 minutes |
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