Comparison of Four Questionnaires for OSA Screening in China

NCT03074747 | Unknown

• 1 other identifier: CT2016
• Study Type: observational
• Target: 1,200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Organic Obstructive Sleep Apnea (Diagnosis); Questionnaire; Chiari Malformation

Outcome Measures

Primary Outcomes (4)

• Berlin questionnair

  The final reports of the questionnaire

  From randomization to complete PSG monitor, assessed up to 3 months

• ASA Checklist

  The final reports of the questionnaire

  From randomization to complete PSG monitor, assessed up to 3 months

• STOP Questionnaire

  The final reports of the questionnaire

  From randomization to complete PSG monitor, assessed up to 3 months

• STOP-Bang Scoring Model

  The final reports of the questionnaire

  From randomization to complete PSG monitor, assessed up to 3 months

Secondary Outcomes (1)

• PSG monitor

  on the day of PSG reservation or before operation

Other Outcomes (4)

• Medical history

  From randomization to complete PSG monitor, assessed up to 3 months

• upper airway assessment

  From randomization to complete PSG monitor, assessed up to 3 months

• adverse events

  during the induction of anesthesia, the whole period of anesthesia, in PACU and postoperative 24 hours

Interventions

questionnaires DIAGNOSTIC_TEST

After filled the questionnaires, the patients will receive the PSG monitoring

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Participants for this study will be recruited 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 ENT sleep center. 2. To accept OSA correction surgery (UPPP). 3. To receive the ophthalmological surgery under general anesthesia.

You may qualify if:

• Adult (18-60ys)
• Male
• ASA Ⅰ～Ⅲ grade
• Applie to receive PSG monitor in sleep center
• Plan to receive ophthalmological surgery under general anesthesia
• To accept OSA correction surgery (UPPP)

You may not qualify if:

• Severe maxillofacial deformities, pharyngeal reconstruction surgery history ( velopharynoplasty, upper and lower jaw orthopedic surgery, cleft lip and palate surgery)
• Disturbance of consciousness, no self-control ability, serious mental illness, long-term alcohol abuse, drug abuse
• Took mental or nervous system drugs within 3 months
• Sleep apnea caused by hypothyroidism, acromegaly, laryngeal spasm, vocal cord paralysis
• Epilepsy, neuromuscular disease
• central sleep apnea
• Ventilator treatment before monitor for more than 1 month
• Llliteracy
• Non-Chinese

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

Related Publications (11)

• Stradling JR, Davies RJ. Sleep. 1: Obstructive sleep apnoea/hypopnoea syndrome: definitions, epidemiology, and natural history. Thorax. 2004 Jan;59(1):73-8. doi: 10.1136/thx.2003.007161.

  PMID: 14694254 RESULT

• 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.

  PMID: 18931212 RESULT

• 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/ANE.0b013e318269cfd7. Epub 2012 Aug 10.

  PMID: 22886843 RESULT

• 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.

  PMID: 21138886 RESULT

• 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. doi: 10.1007/BF03022219.

  PMID: 16527797 RESULT

• Mickelson SA. Preoperative and postoperative management of obstructive sleep apnea patients. Otolaryngol Clin North Am. 2007 Aug;40(4):877-89. doi: 10.1016/j.otc.2007.04.007.

  PMID: 17606028 RESULT

• 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 Society of Anesthesiologists Task Force on Perioperative Management of patients with obstructive sleep apnea. Anesthesiology. 2014 Feb;120(2):268-86. doi: 10.1097/ALN.0000000000000053. No abstract available.

  PMID: 24346178 RESULT

• 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.2012.02.007. Epub 2012 Mar 17.

  PMID: 22425575 RESULT

• 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.

  PMID: 26380759 RESULT

• 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. Anesthesiology. 2008 May;108(5):822-30. doi: 10.1097/ALN.0b013e31816d91b5.

  PMID: 18431117 RESULT

• 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. Epub 2012 Mar 8.

  PMID: 22401881 RESULT

MeSH Terms

Conditions

Disease; Arnold-Chiari Malformation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: March 9, 2017
• Study Start: March 1, 2017
• Primary Completion: March 1, 2017
• Study Completion: December 1, 2018
• Last Updated: March 13, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share