Clinical trial NCT05561231: Comparing Ease of Endotracheal Intubation Using C Blade and D Blade of CMAC Videolaryngoscope in Patients Undergoing Elective Cervical Spine Surgery
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Spine Instability
Keywords: Manual in-line stabilisation
C blade
D blade
Lead sponsor: King Edward Memorial Hospital, Mumbai
Sponsor class: OTHER_GOV
First posted: 2022-09-30
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective single blinded randomised controlled trial
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time taken for successful intubation
timeFrame: During procedure
Secondary outcomes:
measure: Time taken to obtain the best Cormack-Lehane grade
timeFrame: During procedure
measure: Number of attempts, external manouvres, complications
timeFrame: During procedure
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Seth GSMC and KEM Hospital
state: Maharashtra
Study officials:
affiliation: Seth GSMC and KEMH Mumbai
name: Sandhya N Narayanan P, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.