Comparison of Four Questionnaires for OSA Screening in China

Questionnaire Clinical Trial

— COQ  

Official title:

The Comparison of Different Questionnaires for Preoperative Screening and Perioperative Risk Prediction in Obstructive Sleep Apnea Patients in China

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03074747
• Other study ID #: CT2016
• Status: Not yet recruiting
• Phase: N/A
• First received: February 22, 2017
• Last updated: March 9, 2017
• Start date: March 2017
• Est. completion date: December 2018

Study information

• Verified date: March 2017
• Source: Beijing Tongren Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1200
• Est. completion date: December 2018
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

1. Adult (18-60ys)

2. Male

3. ASA ?~? 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

Related Conditions & MeSH terms

• Arnold-Chiari Malformation
• Chiari Malformation
• Congenital Abnormalities
• Organic Obstructive Sleep Apnea (Diagnosis)
• Questionnaire
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Diagnostic Test:
• questionnaires
After filled the questionnaires, the patients will receive the PSG monitoring

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tongren Hospital

References & Publications (11)

Adesanya AO, Lee W, Greilich NB, Joshi GP. Perioperative management of obstructive sleep apnea. Chest. 2010 Dec;138(6):1489-98. doi: 10.1378/chest.10-1108. Review. Erratum in: Chest. 2011 Nov;140(5):1393. — View Citation

American Society of Anesthesiologists Task Force on Perioperative Management of patients with obstructive sleep apnea.. Practice guidelines for the perioperative management of patients with obstructive sleep apnea: an updated report by the American Societ — View Citation

Chung F, Subramanyam R, Liao P, Sasaki E, Shapiro C, Sun Y. High STOP-Bang score indicates a high probability of obstructive sleep apnoea. Br J Anaesth. 2012 May;108(5):768-75. doi: 10.1093/bja/aes022. — View Citation

Chung F, Yegneswaran B, Liao P, Chung SA, Vairavanathan S, Islam S, Khajehdehi A, Shapiro CM. Validation of the Berlin questionnaire and American Society of Anesthesiologists checklist as screening tools for obstructive sleep apnea in surgical patients. A — View Citation

Chung SA, Yuan H, Chung F. A systemic review of obstructive sleep apnea and its implications for anesthesiologists. Anesth Analg. 2008 Nov;107(5):1543-63. doi: 10.1213/ane.0b013e318187c83a. Review. — View Citation

Fischer MK, Martinez D, Cassol CM, Rahmeier L, Vieira LR. Immediate and overnight recumbence-dependent changes of neck circumference: relationship with OSA severity in obese and nonobese subjects. Sleep Med. 2012 Jun;13(6):650-5. doi: 10.1016/j.sleep.2012 — View Citation

Franklin KA, Lindberg E. Obstructive sleep apnea is a common disorder in the population-a review on the epidemiology of sleep apnea. J Thorac Dis. 2015 Aug;7(8):1311-22. doi: 10.3978/j.issn.2072-1439.2015.06.11. Review. — View Citation

Joshi GP, Ankichetty SP, Gan TJ, Chung F. Society for Ambulatory Anesthesia consensus statement on preoperative selection of adult patients with obstructive sleep apnea scheduled for ambulatory surgery. Anesth Analg. 2012 Nov;115(5):1060-8. doi: 10.1213/A — View Citation

Mickelson SA. Preoperative and postoperative management of obstructive sleep apnea patients. Otolaryngol Clin North Am. 2007 Aug;40(4):877-89. Review. — View Citation

Stradling JR, Davies RJ. Sleep. 1: Obstructive sleep apnoea/hypopnoea syndrome: definitions, epidemiology, and natural history. Thorax. 2004 Jan;59(1):73-8. Review. — View Citation

Turner K, VanDenkerkhof E, Lam M, Mackillop W. Perioperative care of patients with obstructive sleep apnea - a survey of Canadian anesthesiologists. Can J Anaesth. 2006 Mar;53(3):299-304. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Medical history	to learn about the medical history	From randomization to complete PSG monitor, assessed up to 3 months
Other	upper airway assessment	for the difficult airway evaluate and management	From randomization to complete PSG monitor, assessed up to 3 months
Other	adverse events	to record the related adverse events during the perioperative period	during the induction of anesthesia, the whole period of anesthesia, in PACU and postoperative 24 hours
Other	continuous pulse oximetry monitor	To monitor the saturation after surgery for the first 24 h	postoperative 24 hours, continuous
Primary	Berlin questionnair	The final reports of the questionnaire	From randomization to complete PSG monitor, assessed up to 3 months
Primary	ASA Checklist	The final reports of the questionnaire	From randomization to complete PSG monitor, assessed up to 3 months
Primary	STOP Questionnaire	The final reports of the questionnaire	From randomization to complete PSG monitor, assessed up to 3 months
Primary	STOP-Bang Scoring Model	The final reports of the questionnaire	From randomization to complete PSG monitor, assessed up to 3 months
Secondary	PSG monitor	golden standard for OSA diagnosis	on the day of PSG reservation or before operation