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.
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;
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- 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
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
- 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.
- 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.
- Conditions
- Cervical Spondylosis
- 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 group | Role | What they receive |
|---|---|---|
| Study group | Patients performed airway obstruction after anterior cervical operation Receives: Other: Medical records collection | |
| Control group | Patients 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.
Demographic data
Age, gender, height, weight (BMI), smoking history, drinking history, hypertension, diabetes mellitus
Measured: Before surgery
Data about operation
Operation method
Measured: During surgery
Data about operation
Operative section location
Measured: During surgery
Data about operation
Operation time
Measured: During surgery
Data about operation
Blood loss during operation
Measured: During surgery
Data about operation
Recovery time of anesthesia
Measured: During surgery
Postoperative data
Postoperative blood pressure
Measured: After surgery to discharge, an average of 1 day
Postoperative data
Drainage volume
Measured: After surgery to discharge, an average of 1 day
Secondary outcomes (4)
History and evaluation
Chronic pharyngitis
Measured: Before surgery
History and evaluation
Sleep monitoring
Measured: Before surgery
Postoperative management
Neck circumference
Measured: After surgery to discharge, an average of 1 day
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.
- First posted21 Jul 2021
- Study start1 Jan 2021
- Primary completion31 May 2021
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical SpondylosisStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors Analysis and Evaluation System Construction of Airway Obstruction After Anterior Cervical Surgery
- ClinicalTrials.gov ID
- NCT04970628
- Acronym / sponsor ID
- LM2020406
- Conditions
- Cervical Spondylosis
- Keywords
- Cervical Spondylosis, Anterior cervical surgery, Postoperative airway obstruction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 21 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
- 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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: Medical records collectionPatients performed airway obstruction after anterior cervical operation |
| Control group | – | Other: Medical records collectionPatients did not perform airway obstruction after anterior cervical operation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (2 listed)
- Patients undergoing anterior cervical surgery from 2010 to 2019;
- Age ≥ 18 years old.
Key exclusion criteria (9 listed)
- Age ≤ 18 years old;
- Patients with neck tumor, infection and goiter;
- Neck soft tissue and bone structure deformity;
- Ankylosing spondylitis;
- Oral and laryngopharyngeal diseases;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical records collectionPatient's medical records before and after surgery. | Other | Control group, Study group |
Primary outcome
Demographic data
Time frame: Before surgery
Age, gender, height, weight (BMI), smoking history, drinking history, hypertension, diabetes mellitus
Data about operation
Time frame: During surgery
Operation method
Data about operation
Time frame: During surgery
Operative section location
Data about operation
Time frame: During surgery
Operation time
Data about operation
Time frame: During surgery
Blood loss during operation
Data about operation
Time frame: During surgery
Recovery time of anesthesia
Postoperative data
Time frame: After surgery to discharge, an average of 1 day
Postoperative blood pressure
Postoperative data
Time frame: After surgery to discharge, an average of 1 day
Drainage volume
4 secondary outcomes
History and evaluation
Time frame: Before surgery
History and evaluation
Time frame: Before surgery
Postoperative management
Time frame: After surgery to discharge, an average of 1 day
Postoperative management
Time frame: After surgery to discharge, an average of 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.