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Risk Factors Analysis After Anterior Cervical Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04970628
Recruitment Status : Active, not recruiting
First Posted : July 21, 2021
Last Update Posted : July 21, 2021
Sponsor:
Information provided by (Responsible Party):
Peking University Third Hospital

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
Cervical Spondylosis 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.

  2. 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.

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Study Type : Observational
Estimated 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 : January 1, 2021
Actual Primary Completion Date : May 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Choking

Group/Cohort 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.




Primary Outcome Measures :
  1. Demographic data [ Time Frame: Before surgery ]
    Age, gender, height, weight (BMI), smoking history, drinking history, hypertension, diabetes mellitus

  2. Data about operation [ Time Frame: During surgery ]
    Operation method

  3. Data about operation [ Time Frame: During surgery ]
    Operative section location

  4. Data about operation [ Time Frame: During surgery ]
    Operation time

  5. Data about operation [ Time Frame: During surgery ]
    Blood loss during operation

  6. Data about operation [ Time Frame: During surgery ]
    Recovery time of anesthesia

  7. Postoperative data [ Time Frame: After surgery to discharge, an average of 1 day ]
    Postoperative blood pressure

  8. Postoperative data [ Time Frame: After surgery to discharge, an average of 1 day ]
    Drainage volume


Secondary Outcome Measures :
  1. History and evaluation [ Time Frame: Before surgery ]
    Chronic pharyngitis

  2. History and evaluation [ Time Frame: Before surgery ]
    Sleep monitoring

  3. Postoperative management [ Time Frame: After surgery to discharge, an average of 1 day ]
    Neck circumference

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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04970628


Locations
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China, Beijing
Peking University Third Hospital
Beijing, Beijing, China, 100083
Sponsors and Collaborators
Peking University Third Hospital
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Responsible Party: Peking University Third Hospital
ClinicalTrials.gov Identifier: NCT04970628    
Other Study ID Numbers: LM2020406
First Posted: July 21, 2021    Key Record Dates
Last Update Posted: July 21, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
Cervical Spondylosis
Anterior cervical surgery
Postoperative airway obstruction
Additional relevant MeSH terms:
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Spondylosis
Airway Obstruction
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases