Point-of-care-Ultrasound for Sleep Apnea

Sleep Apnea, Obstructive Clinical Trial

Official title:

An Exploratory Study of Correlating Point Of Care Ultrasound (POCUS) Measures of Sleep Apnea With STOP-BANG Scoring and Apnea-Hypopnea Index (AHI)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04443582
• Other study ID #: 202001068
• Status: Completed
• Start date: June 10, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2022
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Patients with obstructive sleep apnea (OSA) are at risk for respiratory dysfunction in the perioperative environment. The study is designed to evaluate if point-of-care-ultrasound (POCUS) measurements of upper airway anatomy may identify patients with OSA and their severity.

Description:

Obstructive sleep apnea (OSA) is characterized by recurrent collapse of the pharyngeal airway during sleep, resulting in substantially reduced (hypopnea) or complete cessation (apnea) of airflow despite ongoing breathing efforts. OSA has long been recognized as a heterogeneous disorder with potentially multiple contributing pathophysiological causes but with significant impact to perioperative morbidity. Various OSA phenotypes exist but, the predominant feature is a narrow and collapsible upper airway anatomy and is an interplay between pharyngeal soft tissue, genioglossus muscle tone and the bony anatomy and accounts for up to two-thirds of the variation in the AHI. Identification of moderate-severe OSA is crucial to prevent potential life-threatening cardiopulmonary complications perioperatively.(1) However, a large proportion of patients with OSA remain undiagnosed at the time of surgery.(2) Current screening tools are mainly questionnaire based and are largely sensitive but not specific (3) resulting in many false positives, unnecessary increased resource utilization, cost burden, and legal implications. Gold standard laboratory polysomnography(PSG) study is expensive and not widely available. Point-of-care ultrasound (POCUS) is a readily available, portable, noninvasive tool that has been used for airway evaluation and may be useful for OSA screening.(4-8) Study investigators want to evaluate the various POCUS measures of OSA in the perioperative population and correlate these measurements with the PSG based severity of OSA (based on apnea-hypopnea index -AHI) to find out the best measure or a combination of measures to diagnose the incidence and severity of OSA.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Patients of either gender

• Age 18 through 85

• History of previous sleep study polysomnography (PSG)

Exclusion Criteria:

• No prior sleep study

• History of central sleep apnea

• Craniofacial/oropharyngeal malformations

• Oropharyngeal surgery since the last sleep study

• Ear/Nose/Throat tumor

• History of Ear/Nose/Throat surgery

• Inability to consent

• Non-English speaking

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
United States	University of Iowa	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Rakesh Sondekoppam Vijayashankar

Country where clinical trial is conducted

United States, 

References & Publications (8)

Chen JW, Chang CH, Wang SJ, Chang YT, Huang CC. Submental ultrasound measurement of dynamic tongue base thickness in patients with obstructive sleep apnea. Ultrasound Med Biol. 2014 Nov;40(11):2590-8. doi: 10.1016/j.ultrasmedbio.2014.06.019. Epub 2014 Sep 12. — View Citation

Lahav Y, Rosenzweig E, Heyman Z, Doljansky J, Green A, Dagan Y. Tongue base ultrasound: a diagnostic tool for predicting obstructive sleep apnea. Ann Otol Rhinol Laryngol. 2009 Mar;118(3):179-84. — View Citation

Liu KH, Chu WC, To KW, Ko FW, Tong MW, Chan JW, Hui DS. Sonographic measurement of lateral parapharyngeal wall thickness in patients with obstructive sleep apnea. Sleep. 2007 Nov;30(11):1503-8. — View Citation

Memtsoudis SG, Stundner O, Rasul R, Chiu YL, Sun X, Ramachandran SK, Kaw R, Fleischut P, Mazumdar M. The impact of sleep apnea on postoperative utilization of resources and adverse outcomes. Anesth Analg. 2014 Feb;118(2):407-418. doi: 10.1213/ANE.0000000000000051. — View Citation

Nagappa M, Liao P, Wong J, Auckley D, Ramachandran SK, Memtsoudis S, Mokhlesi B, Chung F. Validation of the STOP-Bang Questionnaire as a Screening Tool for Obstructive Sleep Apnea among Different Populations: A Systematic Review and Meta-Analysis. PLoS One. 2015 Dec 14;10(12):e0143697. doi: 10.1371/journal.pone.0143697. eCollection 2015. Review. — View Citation

Shu CC, Lee P, Lin JW, Huang CT, Chang YC, Yu CJ, Wang HC. The use of sub-mental ultrasonography for identifying patients with severe obstructive sleep apnea. PLoS One. 2013 May 10;8(5):e62848. doi: 10.1371/journal.pone.0062848. Print 2013. — View Citation

Siegel H, Sonies BC, Graham B, McCutchen C, Hunter K, Vega-Bermudez F, Sato S. Obstructive sleep apnea: A study by simultaneous polysomnography and ultrasonic imaging. Neurology. 2000 May 9;54(9):1872. — View Citation

Singh M, Liao P, Kobah S, Wijeysundera DN, Shapiro C, Chung F. Proportion of surgical patients with undiagnosed obstructive sleep apnoea. Br J Anaesth. 2013 Apr;110(4):629-36. doi: 10.1093/bja/aes465. Epub 2012 Dec 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of POCUS measurements with AHI and/or STOP-Bang Scores	The study is designed to assess if there is a correlation of one or a combination of point-of-care-ultrasound measurements with the severity of OSA as denoted by apnea-hypopnea index (AHI) from previous sleep study and/or STOP-Bang scores noted for the presence of OSA in screening exam prior to surgical procedures that require intubation.; STOP-Bang denotes Snoring, Tired, Observed (anyone observed you stop breathing), Pressure (high blood pressure), Body mass index (more than 35 kg/m2), Age (older than 50), Neck size, Gender	1 day