Initial Increase in Cuff Pressure in Anterior Cervical Spinal Surgery

NCT ID: NCT03240042

Last Updated: 2019-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-17
• Study Completion Date: 2018-06-16

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).

Conditions

Pressure Injury; Dysphonia; Dysphagia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Nasoendo group

Participants received nasotracheal intubation under general anesthesia for the anterior cervical spine surgery.

Group Type: EXPERIMENTAL

nasotracheal intubation

Intervention Type: PROCEDURE

The participants either receive intubation via nasal route.

Oroendo group

Participants received orotracheal intubation under general anesthesia for the anterior cervical spine surgery.

Group Type: OTHER

orotracheal intubation

Intervention Type: PROCEDURE

The participants either receive intubation via oral route.

Interventions

nasotracheal intubation

The participants either receive intubation via nasal route.

Intervention Type: PROCEDURE

orotracheal intubation

The participants either receive intubation via oral route.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: lead

Responsible Party

vghtpe user

Principal Investigator, Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wen-Cheng Huang, M.D.,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Neurosurgery, Neurological Institute

Locations

Taipei Veterans General Hospital

Taipei, , Taiwan

Countries

Taiwan

References

Huang WC, Tan EC, Huang SS, Chou CJ, Chang WK, Chu YC. Postoperative Sore Throat Helps Predict Swallowing Disturbance on Postoperative Day 30 of Anterior Cervical Spine Surgery: A Secondary Exploratory Analysis of a Randomized Clinical Trial of Tracheal Intubation Modes. Dysphagia. 2022 Feb;37(1):37-47. doi: 10.1007/s00455-021-10247-x. Epub 2021 Feb 23.

Reference Type: DERIVED

PMID: 33620562 (View on PubMed)

Other Identifiers

2017-07-013C

Identifier Type: -

Identifier Source: org_study_id