Comparing Full vs. Partial Glottis View Using CMAC D-Blade Video Laryngoscope in Simulated Cervical Injury Patient

Intubation; Difficult or Failed Clinical Trial

Official title:

A Randomized Controlled Trial Comparing Full Glottis View vs. Partial Glottis View During Intubation Using CMAC D-Blade Video Laryngoscope in Simulated Cervical Injury Patient

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04833166
• Other study ID #: MREC: 202093-9041
• Status: Completed
• Phase: N/A
• Start date: May 25, 2021
• Est. completion date: February 24, 2022

Study information

• Verified date: September 2022
• Source: University of Malaya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Direct laryngoscope requires proper alignment of the oro-pharyngeal-laryngeal axis to provide an optimal glottic view for intubation. However, in cervical spine patients, this alignment is not possible thus resulting in an increased risk of fail intubations. D-blade comes with an elliptically tapered blade shape rising at the distal end to provide better glottic visualization in comparison with direct laryngoscopes. Hence, CMAC D-blade is preferred in simulated cervical spine injury where intubator needs to maintain a neutral neck position. However, intubation time may be significantly longer due to difficulty in negotiating the endotracheal tube pass vocal cord and impingement of endotracheal tube to the anterior wall of trachea. There is a study published Glidescope which is also a hyperangulated videolaryngoscope suggested that obtaining a partial glottic view of larynx may facilitate a faster and easier tracheal intubation when compare to a full glottis view. The aim of this study is to clinically evaluate the time of tracheal intubation in relation to the full glottic view vs. partial glottic view which is deliberately obtained when using CMAC D-blade video laryngoscopy in simulated cervical spine injury.

Description:

Direct laryngoscope requires proper alignment of the oro-pharyngeal-laryngeal axis to provide the best laryngeal view for intubation. In cervical spine patients, this alignment is not possible resulting in an increased risk of failed intubations. Difficult intubation and failed tracheal intubation are among the major causes of morbidity and mortality associated with anesthesia. In recent years, video laryngoscope has played an increasingly important role in the management of patients with unanticipated difficult or failed endotracheal intubation. When compared with a direct laryngoscope, the video laryngoscope achieved a better view of the glottis and a high rate of successful intubation. On comparing the C-MAC with the conventional Macintosh blade, a conventional C-MAC Macintosh blade 3 and D-blade have a blade angulation of 18° and 40° in the D-blade respectively. In addition, with D-blade is an elliptically tapered blade-shaped rising to distal. This highly angulated C-MAC D blade provides a better glottic visualization in comparison to the direct laryngoscopes and in simulated cervical spine injury. This resulted in successful intubation in routine induction of anesthesia and rescue intubation in patients with difficult airway with C-MAC D Blade. But in terms of intubation time, study has shown a significantly shorter time with C-MAC D Blade compared with other indirect laryngoscopes. This may be due to a common problem seen in indirect video laryngoscopy whereby a good glottic view does not always allow advancing the tube into the trachea. A study has been conducted on Glidescope which is also a hyperangulated blade suggested that obtaining a partial glottic view of larynx may facilitate a faster and easier tracheal intubation when compare to a full glottis view. Randomised controlled trial also showed that GlideScope and C-MAC D blade video laryngoscope using manual inline axial stabilization (MIAS) for tracheal intubation in patients with cervical spine injury/pathology were equally efficacious. The aim of this study is to clinically evaluate the time of tracheal intubation in relation to deliberately obtained full glottic view vs. partial glottic view when using CMAC D-blade video laryngoscopy in simulated cervical spine injury.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: February 24, 2022
• Est. primary completion date: February 24, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

Inclusion Criteria:

• All patients with American Society of Anaesthesiologist (ASA) physical status I-III
• Age (=21-75 years old)
• General anaesthesia requiring tracheal intubation
• Provide written consent to participate in the study

Exclusion Criteria:

• Pregnancy
• Body mass index (BMI) = 35
• Condition requires rapid sequence induction
• Need for fibreoptic intubation
• Need for nasal intubation
• Documented difficult airway during previous surgery
• Recent (3 months) active ischemic heart disease
• Recent (3 months) cerebrovascular disease
• Acute exacerbation of respiratory disease (eg. Uncontrolled asthma, Chronic Obstructive Pulmonary Disease)

Related Conditions & MeSH terms

• Airway Complication of Anesthesia
• Intubation; Difficult or Failed

Intervention

Device:
• CMAC D-blade videolaryngoscope with full or partial glottic view
Deliberate achieving full or partial glottic view on C MAC D-blade video laryngoscope and comparing time and ease of intubation with both arms

Locations

Country	Name	City	State
Malaysia	University Malaya Medical Centre	Kuala Lumpur	Wilayah Persekutuan

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

References & Publications (12)

Adnet F, Borron SW, Lapostolle F, Lapandry C. The three axis alignment theory and the "sniffing position": perpetuation of an anatomic myth? Anesthesiology. 1999 Dec;91(6):1964-5. — View Citation

Caplan RA, Posner KL, Ward RJ, Cheney FW. Adverse respiratory events in anesthesia: a closed claims analysis. Anesthesiology. 1990 May;72(5):828-33. — View Citation

Cavus E, Neumann T, Doerges V, Moeller T, Scharf E, Wagner K, Bein B, Serocki G. First clinical evaluation of the C-MAC D-Blade videolaryngoscope during routine and difficult intubation. Anesth Analg. 2011 Feb;112(2):382-5. doi: 10.1213/ANE.0b013e31820553fb. Epub 2010 Dec 14. — View Citation

Criswell JC, Parr MJ, Nolan JP. Emergency airway management in patients with cervical spine injuries. Anaesthesia. 1994 Oct;49(10):900-3. — View Citation

Gu Y, Robert J, Kovacs G, Milne AD, Morris I, Hung O, MacQuarrie K, Mackinnon S, Adam Law J. A deliberately restricted laryngeal view with the GlideScope® video laryngoscope is associated with faster and easier tracheal intubation when compared with a full glottic view: a randomized clinical trial. Can J Anaesth. 2016 Aug;63(8):928-37. doi: 10.1007/s12630-016-0654-6. Epub 2016 Apr 18. — View Citation

Jain D, Dhankar M, Wig J, Jain A. Comparison of the conventional CMAC and the D-blade CMAC with the direct laryngoscopes in simulated cervical spine injury--a manikin study. Braz J Anesthesiol. 2014 Jul-Aug;64(4):269-74. doi: 10.1016/j.bjane.2013.06.005. Epub 2013 Dec 25. — View Citation

Lewis SR, Butler AR, Parker J, Cook TM, Schofield-Robinson OJ, Smith AF. Videolaryngoscopy versus direct laryngoscopy for adult patients requiring tracheal intubation: a Cochrane Systematic Review. Br J Anaesth. 2017 Sep 1;119(3):369-383. doi: 10.1093/bja/aex228. — View Citation

Mort TC. Emergency tracheal intubation: complications associated with repeated laryngoscopic attempts. Anesth Analg. 2004 Aug;99(2):607-13, table of contents. — View Citation

Serocki G, Neumann T, Scharf E, Dörges V, Cavus E. Indirect videolaryngoscopy with C-MAC D-Blade and GlideScope: a randomized, controlled comparison in patients with suspected difficult airways. Minerva Anestesiol. 2013 Feb;79(2):121-9. Epub 2012 Oct 2. — View Citation

Stroumpoulis K, Pagoulatou A, Violari M, Ikonomou I, Kalantzi N, Kastrinaki K, Xanthos T, Michaloliakou C. Videolaryngoscopy in the management of the difficult airway: a comparison with the Macintosh blade. Eur J Anaesthesiol. 2009 Mar;26(3):218-22. doi: 10.1097/EJA.0b013e32831c84d1. — View Citation

Su YC, Chen CC, Lee YK, Lee JY, Lin KJ. Comparison of video laryngoscopes with direct laryngoscopy for tracheal intubation: a meta-analysis of randomised trials. Eur J Anaesthesiol. 2011 Nov;28(11):788-95. doi: 10.1097/EJA.0b013e32834a34f3. — View Citation

van Zundert A, Maassen R, Lee R, Willems R, Timmerman M, Siemonsma M, Buise M, Wiepking M. A Macintosh laryngoscope blade for videolaryngoscopy reduces stylet use in patients with normal airways. Anesth Analg. 2009 Sep;109(3):825-31. doi: 10.1213/ane.0b013e3181ae39db. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intubation time	This is the time taken from CMAC laryngoscope blade passes patient's lip until the recording of first end tidal CO2 (EtCO2); assessed up to 120 seconds.	during the intervention
Primary	First attempt successful intubation attempt	First intubation attempt success rate between two groups; assessed up to maximum 2 attempts	during the intervention
Secondary	Time to obtain glottic view	Time taken for from CMAC laryngoscope blade passes patient's lip until achieving assigned laryngoscopic view; assessed up to 120 seconds	during the intervention
Secondary	Hemodynamic changes	Blood pressure, mean arterial pressure and heart rate recorded 1 min, 2.5 min then 5 min post intubation	immediately after the intervention
Secondary	Airway trauma	Incidence of oral mucosal trauma, lip laceration, dental laceration; assessed up to discharge from operating theatre.	immediately after the surgery