Risk Factors Analysis After Anterior Cervical Surgery

Sponsor
Peking University Third Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04970628
Collaborator
(none)
100
1
12
8.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Medical records collection

Detailed Description

  1. Research objects 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. They were evaluated by ward doctors, anesthesiologists and ward nurses according to clinical standards. The following inclusion and exclusion criteria were used. Inclusion criteria: patients undergoing anterior cervical surgery from 2010 to 2019; Age ≥ 18 years old. Exclusion criteria: 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.

Grouping of patients:①Case group: patients who underwent anterior cervical spine surgery from 2010 to 2019 and had airway obstruction and re intubation in a short time after surgery. ②Control group: among the patients who never had reoperation of postoperative airway obstruction, the number of cases closest to this time point was collected according to the maximum matching ratio of 1:4 according to the operation time of patients in case group.

  1. Research methods The exposure history of various possible risk factors in the past was collected by inquiring and consulting medical records. Through literature review, the most direct cause of airway obstruction after anterior cervical surgery is the compression of trachea caused by neck hematoma, the increase of respiratory secretions, airway obstruction, dyspnea and even asphyxia. In the research of Li Haoxi, Chen Xiongsheng and other experts, it is pointed out that the age, smoking, body mass index, hypertension, operation mode, operation time and number of operation segments of patients have a significant impact on the airway obstruction after anterior cervical surgery, which is consistent with some foreign related reports. The risk of airway obstruction in smokers and those aged 60 or above increased significantly compared with those who did not smoke and <45 years old. Meanwhile, the incidence rate of chronic pharyngitis in smokers was significantly higher than that in non-smokers. With the increase of smoking time and age, chronic pharyngitis was also a high-risk factor. According to the statistical results of the study, the incidence of re intubation of airway obstruction after single segment anterior cervical surgery was 0.3%, and the incidence of airway obstruction was 4.97% with the increase of surgical segments. Studies suggest that prevention of hematoma, intraoperative clear exposure and thorough hemostasis are the first factors, and treatment of possible active bleeding. In the study, a case of hematoma in a patient with hypertension was taken as an example to point out that patients with hypertension will have the risk of bleeding again after operation. When the patient has obvious obesity, the neck is short and thick in appearance, and tissue edema is easy to occur after operation, resulting in drainage affected. ①preoperative assessment: age, gender, height, weight (BMI), smoking history, drinking history, hypertension, diabetes mellitus, chronic pharyngitis, neck circumference and sleep monitoring.
  • Intraoperative factors: operation mode, operation segment location, operation time, intraoperative blood loss, anesthesia recovery time. ③Postoperative evaluation: respiratory condition, blood oxygen, blood pressure, drainage volume, limb muscle strength, expectoration.

In order to explore the relationship between risk factors and airway obstruction, the exposure proportion of each index in case group and control group was compared.

Study Design

Study Type:
Observational
Anticipated Enrollment :
100 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Risk Factors Analysis and Evaluation System Construction of Airway Obstruction After Anterior Cervical Surgery
Actual Study Start Date :
Jan 1, 2021
Actual Primary Completion Date :
May 31, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Study group

Patients performed airway obstruction after anterior cervical operation

Other: Medical records collection
Patient's medical records before and after surgery.

Control group

Patients did not perform airway obstruction after anterior cervical operation

Other: Medical records collection
Patient's medical records before and after surgery.

Outcome Measures

Primary Outcome Measures

  1. Demographic data [Before surgery]

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

  2. Data about operation [During surgery]

    Operation method

  3. Data about operation [During surgery]

    Operative section location

  4. Data about operation [During surgery]

    Operation time

  5. Data about operation [During surgery]

    Blood loss during operation

  6. Data about operation [During surgery]

    Recovery time of anesthesia

  7. Postoperative data [After surgery to discharge, an average of 1 day]

    Postoperative blood pressure

  8. Postoperative data [After surgery to discharge, an average of 1 day]

    Drainage volume

Secondary Outcome Measures

  1. History and evaluation [Before surgery]

    Chronic pharyngitis

  2. History and evaluation [Before surgery]

    Sleep monitoring

  3. Postoperative management [After surgery to discharge, an average of 1 day]

    Neck circumference

  4. Postoperative management [After surgery to discharge, an average of 1 day]

    Expectoration

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients undergoing anterior cervical surgery from 2010 to 2019;

  • Age ≥ 18 years old.

Exclusion Criteria:
  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking University Third Hospital Beijing Beijing China 100083

Sponsors and Collaborators

  • Peking University Third Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Peking University Third Hospital
ClinicalTrials.gov Identifier:
NCT04970628
Other Study ID Numbers:
  • LM2020406
First Posted:
Jul 21, 2021
Last Update Posted:
Jul 21, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Peking University Third Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 21, 2021