Comparing Ease of Endotracheal Intubation Using C Blade and D Blade of CMAC Videolaryngoscope in Patients Undergoing Elective Cervical Spine Surgery

Cervical Spine Instability Clinical Trial

Official title:

A Prospective Single Blinded Randomised Controlled Trial to Compare Endotracheal Intubation Using C Blade and D Blade of CMAC Videolaryngoscope in Patients Undergoing Elective Cervical Spine Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05561231
• Other study ID #: EC/182/2018
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: November 1, 2019

Study information

• Verified date: September 2022
• Source: King Edward Memorial Hospital, Mumbai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study was done to compare the ease of tracheal intubation using the conventional C blade and the D blade of CMAC videolaryngoscope in patients undergoing cervical spine surgery.

Description:

Manual in-line stabilisation is used to immobilise the neck during endotracheal intubation in patients undergoing cervical spine surgery to prevent secondary spinal cord damage. This makes visualisation of the glottis difficult with conventional laryngoscopy which can be overcome with videolaryngoscope. CMAC Videolaryngoscope has the conventional blade (C blade) and the highly angulated D blade which was introduced to aid in difficult airway. This study was done to compare the ease of tracheal intubation using the conventional C blade and the D blade of CMAC videolaryngoscope in patients undergoing cervical spine surgery.

Methodology: After Institutional Ethics Committee approval and obtaining informed consent, 68 patients undergoing elective cervical spine surgery were randomised into 2 groups - C (intubated with C blade) or D (intubated with D blade) (n=34 each) by computer generated randomisation. After induction of general anaesthesia, manual in-line stabilisation of the cervical spine was achieved and intubation was attempted by experienced anaesthesiologist with the C blade or D blade according to the group. The time taken for successful intubation, time taken for optimum glottic visualisation, the number of attempts, additional manouvres required for successful intubation and the incidence of complications were compared.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: November 1, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with ASA (American Society of Anaesthesiology) grade one and two,

• aged 18 years and older,

• Patients with mouth opening more than two and a half fingers (inter-incisor distance >3cm)

Exclusion Criteria:

• Patients who were unwilling to be a part of the study,

• patients with any oral pathology, hiatus hernia, pregnant women,

• patients with severe systemic diseases

Related Conditions & MeSH terms

• Cervical Spine Instability

Intervention

Procedure:
• Intubation with C blade
Intubation with C blade of CMAC videolaryngoscope
• Intubation with D blade
Intubation with D blade of CMAC videolaryngoscope

Locations

Country	Name	City	State
India	Seth GSMC and KEM Hospital	Mumbai	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
King Edward Memorial Hospital, Mumbai

Country where clinical trial is conducted

India, 

References & Publications (2)

Hazarika H, Saxena A, Meshram P, Kumar Bhargava A. A randomized controlled trial comparing C Mac D Blade and Macintosh laryngoscope for nasotracheal intubation in patients undergoing surgeries for head and neck cancer. Saudi J Anaesth. 2018 Jan-Mar;12(1):35-41. doi: 10.4103/sja.SJA_239_17. — View Citation

Sinha R, Ray BR, Sharma A, Pandey RK, Punj J, Darlong V, Trikha A. Comparison of the C-MAC video laryngoscope size 2 Macintosh blade with size 2 C-MAC D-Blade for laryngoscopy and endotracheal intubation in children with simulated cervical spine injury: A prospective randomized crossover study. J Anaesthesiol Clin Pharmacol. 2019 Oct-Dec;35(4):509-514. doi: 10.4103/joacp.JOACP_106_18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time taken for successful intubation	Comparing the time taken for successful intubation using the C blade and D blade of CMAC videolaryngoscope in patients with manual in-line stabilisation of the cervical spine	During procedure
Secondary	Time taken to obtain the best Cormack-Lehane grade	Comparing the time taken to obtain the best Cormack-Lehane grade using the C blade and D blade of CMAC videolaryngoscope in patients with manual in-line stabilisation of the cervical spine	During procedure
Secondary	Number of attempts, external manouvres, complications	Comparing the number of attempts for successful endotracheal intubation, external manoeuvres or adjuncts required, complications caused using the C blade and D blade of CMAC videolaryngoscope in patients with manual in-line stabilisation of the cervical spine	During procedure