None listed
Conditions
Brief summary
Excessive movement of the neck (cervical spine) during the insertion of a breathing tube can lead to secondary spinal cord injury, especially in patients undergoing cervical spine surgery. This randomized controlled trial aims to compare the degree of cervical spine mobility caused by two different intubation devices: the standard Macintosh laryngoscope and the ClearVue videolaryngoscope. Adult patients scheduled for elective cervical spine surgery are randomly assigned to one of these two groups. During the procedure, fluoroscopic images are captured to measure the motion angles of the cervical vertebrae. The study hypothesizes that using the videolaryngoscope will result in significantly less cervical spine movement compared to the standard Macintosh laryngoscope.
Interventions
- Name: Videolaryngoscopy (ClearVue) with hyper-angulated blade. - Description: Participants in this group undergo endotracheal intubation using the ClearVue videolaryngoscope (Infinium Medical, USA) equipped with a non-channeled, hyper-angulated blade (D-blade, size 3 or 4). A malleable stylet is inserted into the endotracheal tube and pre-curved to 60° to match the blade’s curvature and optical axis. - Procedure details: + Anesthesia: General anesthesia is induced with propofol, fentanyl, and rocuronium. Adequate neuromuscular blockade is confirmed by a Train-of-Four (TOF) ratio of 0% before intubation. + Stabilization: Manual In-Line Stabilization (MILS) is performed by a dedicated assistant to maintain the cervical spine in a neutral position throughout the procedure. + Imaging: Lateral cervical spine images are recorded using fluoroscopy (C-arm) at two specific timepoints: "pre-intubation" (neutral position) and "best glottic view" (static hold just before tube insertion) . + Provider: Intubation is performed by an experienced anesthesiologist. Adherence to the intervention was monitored through a strictly enforced standardized protocol to minimize variability. Specific adherence strategies included: * Objective Monitoring: Neuromuscular blockade was continuously monitored using a TOFscan device, and intubation proceeded only after confirming a TOF ratio of 0%. * Direct Observation: A dedicated research assistant recorded procedural milestones (intubation time) and ensured the assigned laryngoscope was used according to the randomization result. * Imaging Verification: Fluoroscopic images were captured at specific timepoints ("pre-intubation" and "best glottic view") which served as objective evidence that the positioning and stabilization protocols were followed.
Sponsors
Study design
Eligibility
Inclusion criteria
Patients aged 18 years and over. Patients classified as American Society of Anesthesiologists (ASA) physical status I or II. Patients undergoing elective cervical spine surgery. Patients who agreed to participate in the study (signed informed consent).
Exclusion criteria
Patients requiring rapid sequence induction or intubation without muscle relaxants. Patients with limited mouth opening (less than 2 cm). Patients with a Body Mass Index (BMI) (more than 35 kg/m²). Patients with a history of cervical spine or maxillofacial surgery. Patients with ankylosing spondylitis. Patients with cervical spine trauma accompanied by spinal cord injury.