Initial Increase in Cuff Pressure in Anterior Cervical Spinal Surgery

Dysphagia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03240042
• Other study ID #: 2017-07-013C
• Status: Completed
• Phase: N/A
• Start date: October 17, 2017
• Est. completion date: June 16, 2018

Study information

• Verified date: April 2019
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: June 16, 2018
• Est. primary completion date: May 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Crush Injuries
• Dysphagia
• Dysphonia
• Hoarseness
• Pressure Injury

Intervention

Procedure:
• nasotracheal intubation
The participants either receive intubation via nasal route.
• orotracheal intubation
The participants either receive intubation via oral route.

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cuff pressure	cuff pressure of endotracheal tube	from time of randomization until postoperative 30 days
Secondary	sore throat	postoperative 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.	from time of randomization until postoperative 30 days
Secondary	dysphonia	postoperative dysphonia by dysphonia scoring system. subjecte grading of voice change with none, mild and obvious, in terms of hoarseness,pitch and loudness.	from time of randomization until postoperative 30 days
Secondary	dysphagia	postoperative 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.	rom time of randomization until postoperative 30 days