NCT05188807

Brief Summary

Cervical spine disorders can cause neck pain with or without neurological dysfunction. The most common cause of acute and chronic neck pain is cervical degenerative changes. Surgical decision of cervical pathology is made by anamnesis, neurological examination and imaging methods. Airway management can be difficult for patients presenting for cervical spine surgery. In addition, these patients may have severe cervical spine instability or spinal cord level myelopathy and may develop serious neurological complications associated with the intubation technique. Videolaringoscopes, which have become widely used with the developing technology, provide a better view than direct laryngoscopy in terms of cervical immobilization during intubation. Therefore, videolaryngoscope is preferred for cervical pathologies. Nowadays, the use of videolaryngoscope is recommended in patients with airway difficulty. Neutral position is important for intubation of patients with cervical pathology and it is highly recommended in the literature to evaluate these patients as difficult airways. All cervical patients are intubated with videolaryngoscope in investigator's clinic. The aim of this study was to evaluate how long the duration of cervical pathology affects airway anatomy and how it affects airway management during anesthesia. On the other hand, airway-related measurements will be performed by MRI and ultrasonography (USG), which is routinely evaluated in the diagnosis process, and it will be aimed to evaluate these measurements in terms of their effects on intubation quality. At the end of the study, all evaluations were analyzed and it was aimed to compare the effects of other evaluated parameters (such as USG and MRI measurements) on intubation difficulty level, with cervical pathology duration being primary.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 12, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

2.1 years

First QC Date

December 4, 2021

Last Update Submit

November 15, 2023

Conditions

Keywords

videolaryngoscopyquality of intubationcervical pathologydifficult airway

Outcome Measures

Primary Outcomes (1)

  • intubation time in seconds

    for assessing the degree of difficulty in intubation

    10 minutes

Secondary Outcomes (1)

  • distance of measurements of airway

    10 minutes

Study Arms (1)

The patient with cervical pathology

EXPERIMENTAL

we will perform airway ultrasonography before the patients intubations and we will intubate the patients before cervical surgery

Diagnostic Test: Airway ultrasonography

Interventions

Airway ultrasonographyDIAGNOSTIC_TEST

we will measure hyomental distance, skin-epiglottis distance, skin-hyoid distance, epiglottis-vocalcords distance

The patient with cervical pathology

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Elective cervical surgery

You may not qualify if:

  • Patients undergoing emergency surgery
  • Cervical tumor patients
  • Patients with cognitive dysfunction
  • Patients with previous cervical surgery
  • Pediatric patients
  • Cervical trauma patients
  • The presence of cervical spondylitis, spondylodiscitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University School of Medicine

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neck PainUterine Cervical Diseases

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Gulencan Yumusak Ergin

    Ankara University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 4, 2021

First Posted

January 12, 2022

Study Start

August 1, 2021

Primary Completion

August 30, 2023

Study Completion

November 1, 2023

Last Updated

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations