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

NCT04833166 | Completed

• 1 other identifier: MREC: 202093-9041
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intubation; Difficult or Failed; Airway Complication of Anesthesia

Keywords

Glottic view; Intubation time; C MAC D- blade

Outcome Measures

Primary Outcomes (2)

• 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

• First attempt successful intubation attempt

  First intubation attempt success rate between two groups; assessed up to maximum 2 attempts

  during the intervention

Secondary Outcomes (3)

• Time to obtain glottic view

  during the intervention

• Hemodynamic changes

  immediately after the intervention

• Airway trauma

  immediately after the surgery

Study Arms (2)

Full glottic view on CMAC- D blade

EXPERIMENTAL

Deliberately obtaining a full glottis view is defined as negotiation and advancement of CMAC D blade tip positioned at the vallecula. Occasionally, external laryngeal pressure may be needed to assist in obtaining a full glottic view. The full glottic view is defined as a percentage of glottic opening (POGO) approximate 100%.

Device: CMAC D-blade videolaryngoscope with full or partial glottic view

Partial glottic view on CMAC- D blade

ACTIVE COMPARATOR

The partial glottis view is defined as a percentage of glottic opening \<50%. This is achieved by deliberately position the CMAC D-blade tip proximally away from the vallecular.

Device: CMAC D-blade videolaryngoscope with full or partial glottic view

Interventions

CMAC D-blade videolaryngoscope with full or partial glottic view DEVICE

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

Full glottic view on CMAC- D blade; Partial glottic view on CMAC- D blade

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

University Malaya Medical Centre

Kuala Lumpur, Kuala Lumpur, 58200, Malaysia

Location

Related Publications (13)

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  PMID: 2339799 BACKGROUND

• Mort TC. Emergency tracheal intubation: complications associated with repeated laryngoscopic attempts. Anesth Analg. 2004 Aug;99(2):607-13, table of contents. doi: 10.1213/01.ANE.0000122825.04923.15.

  PMID: 15271750 BACKGROUND

• 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.

  PMID: 19237983 BACKGROUND

• 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.

  PMID: 21897263 BACKGROUND

• 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.

  PMID: 28969318 BACKGROUND

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  PMID: 21156978 BACKGROUND

• 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.

  PMID: 24998112 BACKGROUND

• Serocki G, Neumann T, Scharf E, Dorges 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.

  PMID: 23032922 BACKGROUND

• 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.

  PMID: 19690253 BACKGROUND

• 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(R) 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.

  PMID: 27090535 BACKGROUND

• Cheong CC, Ong SY, Lim SM, Wan A WZ, Mansor M, Chaw SH. Partial vs full glottic view with CMACTM D blade intubation of airway with simulated cervical spine injury: a randomized controlled trial. Expert Rev Med Devices. 2023 Feb;20(2):151-160. doi: 10.1080/17434440.2023.2174850. Epub 2023 Feb 6.

  PMID: 36715659 DERIVED

Study Officials

• Siu Min Lim, MMed Master

  University of Malaya

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor/ Clinical Anaesthesiologist/ Clinical Lecturer

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: April 6, 2021
• Study Start: May 25, 2021
• Primary Completion: February 24, 2022
• Study Completion: February 24, 2022
• Last Updated: September 13, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)