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Initial Increase in Cuff Pressure in Anterior Cervical Spinal Surgery

Initial Increase in Cuff Pressure After Neck Retraction for Anterior Spine Surgery: Comparison Between Orotracheal and Nasotracheal Intubation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03240042
Enrollment
118
Registered
2017-08-04
Start date
2017-10-17
Completion date
2018-06-16
Last updated
2019-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysphagia, Dysphonia, Pressure Injury

Keywords

anterior cervical spine surgery, endotracheal cuff pressure, endotracheal tracheal intubation, dysphonia

Brief summary

When the retractor blades oped and is positioned to provide the surgical access in the anterior cervical spine surgery, it cause the trachea to deviate laterally and pose pressure on the tissue between the retractor and the trachea. This is convincible as revealed by the increase of cuff pressure of endotracheal tube. The study aims to investigate differences in the increase of cuff pressure after retractor is positioned between nasotracheal and orotracheal intubation.

Detailed description

When the retractor blades oped and is positioned to provide the surgical access in the anterior cervical spine surgery, it cause the trachea to deviate laterally and pose pressure on the tissue between the retractor and the trachea. The most important structure is the recurrent laryngeal nerve. This is convincible as revealed by the increase of cuff pressure of endotracheal tube. The pressure created by the retractor may be related to postoperative dysphonia and dysphagia. In view of minimizing the pressure created by the retractors, some neurosurgeons advocate to deflate then to inflate the cuff of ETT tube after the retractor is on, while some advocate monitoring of cuff pressure and keep below 25 mmHg. Nasotracheal or orotracheal tube can both be applied to general anesthesia for the anterior cervical spine surgery. The option depends on the surgeons' preference. Though both approaches end at the trachea, the nasotracheal tube is fixed at the nostril, and orotracheal tube, at the mouth angle, on the opposite side of surgical approach. The investigators hypothetize this difference in location results in different degree of deviation and increase of cuff pressure. The study aims to investigate differences in the increase of cuff pressure after retractor is positioned between nasoendotracheal and oroendotracheal intubation. Apfelbaum and colleagues indicated the asymmetric position of the oroETT within the larynx as being fixed distally by the cuff and proximally by taping at the mouth angle. The asymmetry of the tube shaft and cuff may contribute to unilateral vocal palsy. When the retractors are set up for ACCS, the deviation of cuff towards the retractors increases ETCP and creates a extrusion compression of tissues in between the cuff and the retractor blade. Nasotracheal intubation follows a more natural trajectory into the trachea. In theory, a nasoETT is more centrally located and less asymmetric in the thyroid cartilage and trachea; thus pressure from this tube may be relatively evenly distributed, and the pressure on the surrounding tissues is lower. Therefore, we hypothesised lower degree of tissue compression with a nasoETT, even during retractor splay. The effect may be reflected in intraoperative ETCP or post-ACCS dysphonia. This randomised controlled clinical trial assessed the differences in the tracheal intubation mode on the maximal ETCP during retractor splay (primary endpoint) and post-ACSS dysphonia (secondary endpoint).

Interventions

PROCEDUREnasotracheal intubation

The participants either receive intubation via nasal route.

PROCEDUREorotracheal intubation

The participants either receive intubation via oral route.

Sponsors

Taipei Veterans General Hospital, Taiwan
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

Participants are randomly allocated into one of the two group: nasoendotracheal and oroendotracheal group

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

Aged 20-80 Scheduled cervical spine surgery, anterior approach

Exclusion criteria

* Severe spinal stenosis and requiring fiberoptic intubation * Unstable spine and require orthosis * Hisotory of difficult intubation * History of cervical spine or neck surgery * Coagulopathy * Nasal pathology * Lack of informed consent * History of previous cervical spine or neck surgery * Anterior cervical spine surgeries after trauma, tumour resection, or spinal infection * Preoperative dysphonia or dysphagia, regardless of the aetiology

Design outcomes

Primary

MeasureTime frameDescription
cuff pressurefrom time of randomization until postoperative 30 dayscuff pressure of endotracheal tube

Secondary

MeasureTime frameDescription
sore throatfrom time of randomization until postoperative 30 dayspostoperative sore throat by numerical rating scale (NRS), ranging from 0-10cm, 0 denoting minimal sore throat, 10 denoting maximal sore throat. score of 0 represents better outcome than score of 10.
dysphoniafrom time of randomization until postoperative 30 dayspostoperative dysphonia by dysphonia scoring system. subjecte grading of voice change with none, mild and obvious, in terms of hoarseness,pitch and loudness.
dysphagiarom time of randomization until postoperative 30 dayspostoperative dysphonia by BAZAZ dysphagia scoring system. Severity of dsyphagia is classified as none, mild, moderate and severe. None indicates no swallowing difficulty for liquid and solid food. Mild indicated no difficulty for liquid, and rare diffilulty for solid food. Moderate indicates none or rare difficulty for liquid, occasional difficulty for solid. Severe indicates presence of difficulty for liquid and frequent difficulty for solid food.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026