ClinicalTrials.Veeva

Menu

Initial Increase in Cuff Pressure in Anterior Cervical Spinal Surgery

T

Taipei Veterans General Hospital

Status

Completed

Conditions

Dysphagia
Dysphonia
Pressure Injury

Treatments

Procedure: nasotracheal intubation
Procedure: orotracheal intubation

Study type

Interventional

Funder types

Other

Identifiers

NCT03240042
2017-07-013C

Details and patient eligibility

About

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.

Full 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).

Enrollment

118 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

118 participants in 2 patient groups

Nasoendo group
Experimental group
Description:
Participants received nasotracheal intubation under general anesthesia for the anterior cervical spine surgery.
Treatment:
Procedure: nasotracheal intubation
Oroendo group
Other group
Description:
Participants received orotracheal intubation under general anesthesia for the anterior cervical spine surgery.
Treatment:
Procedure: orotracheal intubation

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems