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Cervical SpondylosisNCT04970628

Risk Factors Analysis After Anterior Cervical Surgery

An observational study of Cervical Spondylosis, run by Peking University Third Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cervical Spondylosis
What is being tested?
Medical records collection
How many people
100 participants
Where
1 siteChina
Study dates
1 Jan 2021to 31 Dec 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • 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;
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site
  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100083

Other trials in China

About this study

Official title: Risk Factors Analysis and Evaluation System Construction of Airway Obstruction After Anterior Cervical Surgery

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.

Read the 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.

Being tested
Medical records collection
Keywords
Cervical Spondylosis, Anterior cervical surgery, Postoperative airway obstruction
Medical subject headings
Spondylosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Medical records collectionOther

    Patient's medical records before and after surgery.

Study groups in NCT04970628
Study groupRoleWhat they receive
Study groupPatients performed airway obstruction after anterior cervical operation
Receives: Other: Medical records collection
Control groupPatients did not perform airway obstruction after anterior cervical operation
Receives: Other: Medical records collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Demographic data

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

    Measured: Before surgery

  2. Data about operation

    Operation method

    Measured: During surgery

  3. Data about operation

    Operative section location

    Measured: During surgery

  4. Data about operation

    Operation time

    Measured: During surgery

  5. Data about operation

    Blood loss during operation

    Measured: During surgery

  6. Data about operation

    Recovery time of anesthesia

    Measured: During surgery

  7. Postoperative data

    Postoperative blood pressure

    Measured: After surgery to discharge, an average of 1 day

  8. Postoperative data

    Drainage volume

    Measured: After surgery to discharge, an average of 1 day

Secondary outcomes (4)
  1. History and evaluation

    Chronic pharyngitis

    Measured: Before surgery

  2. History and evaluation

    Sleep monitoring

    Measured: Before surgery

  3. Postoperative management

    Neck circumference

    Measured: After surgery to discharge, an average of 1 day

  4. Postoperative management

    Expectoration

    Measured: After surgery to discharge, an average of 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2021
  2. Study start1 Jan 2021
  3. Primary completion31 May 2021
  4. Study completion31 Dec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04970628
Sponsor's protocol ID
LM2020406
Status last verified
Jul 2021
First submitted
1 Jul 2021
Last updated
21 Jul 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cervical Spondylosis, run by Peking University Third Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Demographic data (time frame: Before surgery). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2021.

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