Head Elevated Position and Hyper-angulated Video-laryngoscope Guided Intubation

Intubation; Difficult or Failed Clinical Trial

Official title:

Effect of Head Elevated Position on Ease of Tracheal Intubation Using Hyper-angulated Video-laryngoscope in Patients With Simulated Difficult Airway

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05671978
• Other study ID #: 2022-11-010-001
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 16, 2023
• Est. completion date: October 1, 2023

Study information

• Verified date: January 2023
• Source: Hallym University Kangnam Sacred Heart Hospital
• Contact: Joo Hyun Jun, MD, PhD
• Phone: +82-2-829-5740
• Email: ilpleut[@]naver.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Cervical immobilization with manual in-line stabilization (MILS) is recommended to prevent further neurologic injury during intubation in patients with known or suspected cervical spine injuries. However, MILS is associated with increased rates of failed tracheal intubation using direct laryngoscopy, because the restriction of neck flexion and head extension may prevent adequate alignment of the oral, pharyngeal, and tracheal axes, hence adversely affecting laryngeal visualization during direct laryngoscopy. The GlideScope® (Verathon, Bothell, WA, USA) is a videolaryngoscope with an hyer-angulated blade (HA-VL), which is characterized by a sharper curvature than the Macintosh blade. The large curvature of the HA-VL allows seeing 'round the corner', which can provide indirect laryngeal visualization even with restricted neck movements . However, the HA-VL also prevents direct visualization of larynx, which make it difficult to guide the tracheal tube (TT) towards the glottis despite obtaining a good laryngeal view. Thus, the good view of the laryngeal inlet provided by videolaryngoscopes does not always lead to an easy or successful intubation. There are numerous reports in the literature of devices managing to achieve an improvement in view but still being unable to pass an TT to laryngeal inlet. Thus, the key to a successful tracheal intubation using HA-VL lies not in the laryngeal view obtained but in the ease of inserting the TT. Recent meta studies comparing alternative intubation devices with the standard Macintosh laryngoscope in subjects with cervical spine immobilization reported that GlideScope® was associated with improved glottis visualization but no statistically significant differences in intubation failure or time to intubation compared with direct laryngoscopy. The sniffing position recommended for direct laryngoscopy has been reported to interfere with successful tracheal intubation with HA-VL because flexion of the neck narrows the angle between the sternum and the chin, making it more difficult to insert the HA-VL blade into mouth. In contrast, placing the patient in a 'neutral' or 'back-up head-elevated (BUHE)' position was not associated with a higher incidence of difficult laryngoscope with HA-VL. Given that the 'BUHE' position, when compared with the regular supine position, extend the safe apnoea time during direct laryngoscopy, this position seems better suited for HA-VL than neutral position. However, there is currently insufficient evidence to recommend a specific patient position for the use of HA-VL. Previous studies using magnetic resonance imaging (MRI) suggests that head elevation until the external auditory meatus and sternal notch (AM-S) are in the horizonal plane leads to better anatomic alignment of the pharyngeal and laryngeal axes. Investigators therefore hypothesized that BUHE position (to align the AM-S in horizontal plane), compared with neutral position, would allow a relatively straight passage which makes it easier to guide the TT into the laryngeal inlet (facilitates insertion of TT into the laryngeal entrance) during HA-VL guided intubation. To compare the effect of the BUHE position and the neutral position on the ease of tracheal intubation using a HA-VL (GlideScope®), MILS was applied to patients without any known or suspected neck pathology as a way of simulating a difficult airway. The primary outcome was the tracheal intubation time with both positions. Secondary outcomes examined included rates of successful tracheal intubation and intubation success rate, number of intubation attempts, heart rate responses during intubation, and handling of the Glidesope VL after alignment of the EAM and sternal notch.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 182
• Est. completion date: October 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• patients of ASA physical status 1-2 who were scheduled for elective surgery under general anaesthesia requiring tracheal intubation.

Exclusion Criteria:

• if they required rapid sequence induction;
• history of previous difficult direct laryngoscopy
• unwilling to provide informed consent
• uncontrolled hypertension
• history of ischaemic heart disease without optimal control of symptoms
• history of acute or recent stroke or myocardial infarction
• cervical spine instability or cervical myelopathy
• symptomatic asthma or reactive airway disease requiring daily pharmacological treatment for control of symptoms
• history of gastric reflux.

Related Conditions & MeSH terms

• Intubation; Difficult or Failed

Intervention

Procedure:
• back-up head elevated position
The patient was then placed in the back-up head elevated position to align the external auditory meatus and sternal notch, which was achieved by breaking the operating table
• neutral position
The patient was then placed in the netural position

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hallym University Kangnam Sacred Heart Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ease of tracheal intubation (easy/modified/unachievable)	the need for optimization procedure to facilitate laryngeal visualization and tracheal intubation easy: no need for optimization procedure. modified: need for optimization procedure unachievable: unable to insert tracheal tube even after optimzation procedure	The time from the insertion of laryngoscope into oral cavity until tracheal intubation over 1minute period
Secondary	intubation time	time required for intubation	: The time from the insertion of laryngoscope into oral cavity until its removal over 1 minute period
Secondary	percentage of glottic opening (POGO) score (0-100%)	percentage of glottic opening (0 - 100) 0%: visualization of none of the glottis 100%: visualization of the whole glottis	During laryngeal visualization by laryngoscope over 1 minute period