Chiari Malformation, Organic Obstructive Sleep Apnea (Diagnosis), Questionnaire
Conditions
Brief summary
Background: Obstructive sleep apnea (OSA) refers to the apnea and hypopnea caused by upper airway obstruction during sleep. Patients are associated with sleep disorders, frequent desaturation, hypertension, coronary heart disease, cerebrovascular disease and diabetes. OSA prevalence increased in China in recent years. It is estimated that nearly 80% of men and 93% of women are not diagnosed for moderate and severe OSA. Anesthesiologists and surgeons paid more attention on those high risk patients. The gold standard for OSA diagnosis is apnea and hypopnea index (AHI) obtained from polysomnography (PSG). But it is difficult to carry out PSG regularly in primary health care institutions in China for its high cost and long waiting list. So many OSA questionnaires are developed in Europe and North America, obesity is an important risk factor for OSA for them. But in China people have different anatomical characteristics, the diagnosis sensitivity and specificity of those methods has not been reported in China. Methods and Design: Participants for this study will be recruited in Beijing Tongren Hospital scheduled for elective surgery under general anesthesia. A total of 1200 adult male patients will be enrolled. It is including 3 kinds of persons. 1. To accept PSG monitor in sleep center. 2. To receive OSA correction surgery (UPPP). 3. To receive ophthalmological surgery under general anesthesia. Detailed inquiry and record all medical history. Upper airway assessment will be recorded. Preoperative snoring questionnaires will be integrated according to the four questionnaires. All patients complete PSG monitor. For patients undergoing surgical treatment, postoperative continuous pulse oximetry will be recorded for 24 hours. All postoperative adverse events will be recorded. The primary endpoint: All the patients complete the four snoring questionnaires (ASA, Berlin, STOP and STOP-BANG) before PSG test. The secondary endpoints: PSG monitor will be completed before operation. Medical history, upper airway assessment, postoperative 24 hours continuous pulse oximetry monitor and all perioperative adverse events will be recorded. The purpose is to compare the specificity and sensitivity of four questionnaires to figure out OSA. To find suspected OSA patients before operation with one easy-to-use assessment questionnaire and direct OSA clinical practice.
Interventions
DIAGNOSTIC_TESTquestionnaires
After filled the questionnaires, the patients will receive the PSG monitoring
Sponsors
Beijing Tongren Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Adult (18-60ys) 2. Male 3. ASA Ⅰ～Ⅲ grade 4. Applie to receive PSG monitor in sleep center 5. Plan to receive ophthalmological surgery under general anesthesia 6. To accept OSA correction surgery (UPPP)
Exclusion criteria
1. Severe maxillofacial deformities, pharyngeal reconstruction surgery history ( velopharynoplasty, upper and lower jaw orthopedic surgery, cleft lip and palate surgery) 2. Disturbance of consciousness, no self-control ability, serious mental illness, long-term alcohol abuse, drug abuse 3. Took mental or nervous system drugs within 3 months 4. Sleep apnea caused by hypothyroidism, acromegaly, laryngeal spasm, vocal cord paralysis 5. Epilepsy, neuromuscular disease 6. central sleep apnea 7. Ventilator treatment before monitor for more than 1 month 8. Llliteracy 9. Non-Chinese
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Berlin questionnair | From randomization to complete PSG monitor, assessed up to 3 months | The final reports of the questionnaire |
| STOP-Bang Scoring Model | From randomization to complete PSG monitor, assessed up to 3 months | The final reports of the questionnaire |
| STOP Questionnaire | From randomization to complete PSG monitor, assessed up to 3 months | The final reports of the questionnaire |
| ASA Checklist | From randomization to complete PSG monitor, assessed up to 3 months | The final reports of the questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PSG monitor | on the day of PSG reservation or before operation | golden standard for OSA diagnosis |
Other
| Measure | Time frame | Description |
|---|---|---|
| Medical history | From randomization to complete PSG monitor, assessed up to 3 months | to learn about the medical history |
| continuous pulse oximetry monitor | postoperative 24 hours, continuous | To monitor the saturation after surgery for the first 24 h |
| adverse events | during the induction of anesthesia, the whole period of anesthesia, in PACU and postoperative 24 hours | to record the related adverse events during the perioperative period |
| upper airway assessment | From randomization to complete PSG monitor, assessed up to 3 months | for the difficult airway evaluate and management |
Outcome results
None listed