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Initial Increase in Cuff Pressure in Anterior Cervical Spinal Surgery

Primary Purpose

Pressure Injury, Dysphonia, Dysphagia

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
nasotracheal intubation
orotracheal intubation
Sponsored by
Taipei Veterans General Hospital, Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pressure Injury focused on measuring anterior cervical spine surgery, endotracheal cuff pressure, endotracheal tracheal intubation, dysphonia

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Taipei Veterans General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Nasoendo group

Oroendo group

Arm Description

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

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

Outcomes

Primary Outcome Measures

cuff pressure
cuff pressure of endotracheal tube

Secondary Outcome Measures

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.
dysphonia
postoperative dysphonia by dysphonia scoring system. subjecte grading of voice change with none, mild and obvious, in terms of hoarseness,pitch and loudness.
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.

Full Information

First Posted
August 2, 2017
Last Updated
April 16, 2019
Sponsor
Taipei Veterans General Hospital, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT03240042
Brief Title
Initial Increase in Cuff Pressure in Anterior Cervical Spinal Surgery
Official Title
Initial Increase in Cuff Pressure After Neck Retraction for Anterior Spine Surgery: Comparison Between Orotracheal and Nasotracheal Intubation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
October 17, 2017 (Actual)
Primary Completion Date
May 15, 2018 (Actual)
Study Completion Date
June 16, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pressure Injury, Dysphonia, Dysphagia
Keywords
anterior cervical spine surgery, endotracheal cuff pressure, endotracheal tracheal intubation, dysphonia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are randomly allocated into one of the two group: nasoendotracheal and oroendotracheal group
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
118 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nasoendo group
Arm Type
Experimental
Arm Description
Participants received nasotracheal intubation under general anesthesia for the anterior cervical spine surgery.
Arm Title
Oroendo group
Arm Type
Other
Arm Description
Participants received orotracheal intubation under general anesthesia for the anterior cervical spine surgery.
Intervention Type
Procedure
Intervention Name(s)
nasotracheal intubation
Intervention Description
The participants either receive intubation via nasal route.
Intervention Type
Procedure
Intervention Name(s)
orotracheal intubation
Intervention Description
The participants either receive intubation via oral route.
Primary Outcome Measure Information:
Title
cuff pressure
Description
cuff pressure of endotracheal tube
Time Frame
from time of randomization until postoperative 30 days
Secondary Outcome Measure Information:
Title
sore throat
Description
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.
Time Frame
from time of randomization until postoperative 30 days
Title
dysphonia
Description
postoperative dysphonia by dysphonia scoring system. subjecte grading of voice change with none, mild and obvious, in terms of hoarseness,pitch and loudness.
Time Frame
from time of randomization until postoperative 30 days
Title
dysphagia
Description
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.
Time Frame
rom time of randomization until postoperative 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen-Cheng Huang, M.D.,Ph.D.
Organizational Affiliation
Department of Neurosurgery, Neurological Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
112
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33620562
Citation
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.
Results Reference
derived

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Initial Increase in Cuff Pressure in Anterior Cervical Spinal Surgery

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