NCT04970628

Brief Summary

This study is to collect and summarize the cases of airway obstruction after anterior cervical operation through retrospective case analysis, to explore the risk factors of airway obstruction after anterior cervical operation, to provide the basis for the construction of evaluation system and provide reference for the nursing of postoperative complications.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 1, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 21, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

July 21, 2021

Status Verified

July 1, 2021

Enrollment Period

5 months

First QC Date

July 1, 2021

Last Update Submit

July 12, 2021

Conditions

Cervical Spondylosis

Keywords

Cervical SpondylosisAnterior cervical surgeryPostoperative airway obstruction

Outcome Measures

Primary Outcomes (8)

  • Demographic data

    Age, gender, height, weight (BMI), smoking history, drinking history, hypertension, diabetes mellitus

    Before surgery

  • Data about operation

    Operation method

    During surgery

  • Data about operation

    Operative section location

    During surgery

  • Data about operation

    Operation time

    During surgery

  • Data about operation

    Blood loss during operation

    During surgery

  • Data about operation

    Recovery time of anesthesia

    During surgery

  • Postoperative data

    Postoperative blood pressure

    After surgery to discharge, an average of 1 day

  • Postoperative data

    Drainage volume

    After surgery to discharge, an average of 1 day

Secondary Outcomes (4)

  • History and evaluation

    Before surgery

  • History and evaluation

    Before surgery

  • Postoperative management

    After surgery to discharge, an average of 1 day

  • Postoperative management

    After surgery to discharge, an average of 1 day

Study Arms (2)

Study group

Patients performed airway obstruction after anterior cervical operation

Other: Medical records collection

Control group

Patients did not perform airway obstruction after anterior cervical operation

Other: Medical records collection

Interventions

Medical records collectionOTHER

Patient's medical records before and after surgery.

Control groupStudy group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The clinical data of patients who underwent anterior cervical surgery in our department from 2010 to 2019 were retrospectively collected. The cases of patients who underwent reoperation and those who did not underwent reoperation and the causes of airway obstruction were analyzed.

You may qualify if:

  • Patients undergoing anterior cervical surgery from 2010 to 2019;
  • Age ≥ 18 years old.

You may not qualify if:

  • Age ≤ 18 years old;
  • Patients with neck tumor, infection and goiter;
  • Neck soft tissue and bone structure deformity;
  • Ankylosing spondylitis;
  • Oral and laryngopharyngeal diseases;
  • Hysteria or mental illness;
  • Postoperative anesthesia can not be normal resuscitation patients;
  • Nervous system diseases: such as Parkinson's disease.
  • Patients with airway obstruction due to epidural hematoma underwent reoperation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100083, China

Location

MeSH Terms

Conditions

Spondylosis

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2021

First Posted

July 21, 2021

Study Start

January 1, 2021

Primary Completion

May 31, 2021

Study Completion

December 31, 2021

Last Updated

July 21, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)