NCT03240042

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
118

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

Shorter than P25 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

First Submitted

Initial submission to the registry

August 2, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 4, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

October 17, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2018

Completed
Last Updated

April 18, 2019

Status Verified

April 1, 2019

Enrollment Period

7 months

First QC Date

August 2, 2017

Last Update Submit

April 16, 2019

Conditions

Pressure InjuryDysphoniaDysphagia

Keywords

anterior cervical spine surgeryendotracheal cuff pressureendotracheal tracheal intubationdysphonia

Outcome Measures

Primary Outcomes (1)

  • cuff pressure

    cuff pressure of endotracheal tube

    from time of randomization until postoperative 30 days

Secondary Outcomes (3)

  • sore throat

    from time of randomization until postoperative 30 days

  • dysphonia

    from time of randomization until postoperative 30 days

  • dysphagia

    rom time of randomization until postoperative 30 days

Study Arms (2)

Nasoendo group

EXPERIMENTAL

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

Procedure: nasotracheal intubation

Oroendo group

OTHER

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

Procedure: orotracheal intubation

Interventions

nasotracheal intubationPROCEDURE

The participants either receive intubation via nasal route.

Nasoendo group
orotracheal intubationPROCEDURE

The participants either receive intubation via oral route.

Oroendo group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 20-80 Scheduled cervical spine surgery, anterior approach

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 33620562DERIVED

MeSH Terms

Conditions

Pressure UlcerDysphoniaDeglutition Disorders

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue DiseasesVoice DisordersLaryngeal DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal Diseases

Study Officials

  • Wen-Cheng Huang, M.D.,Ph.D.

    Department of Neurosurgery, Neurological Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants are randomly allocated into one of the two group: nasoendotracheal and oroendotracheal group
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Associate Professor

Study Record Dates

First Submitted

August 2, 2017

First Posted

August 4, 2017

Study Start

October 17, 2017

Primary Completion

May 15, 2018

Study Completion

June 16, 2018

Last Updated

April 18, 2019

Record last verified: 2019-04

Locations

TW(1)