Point-of-care-Ultrasound for Sleep Apnea

NCT ID: NCT04443582

Last Updated: 2022-02-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 140 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-10
• Study Completion Date: 2021-12-31

Brief 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.

Detailed 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.

Conditions

Sleep Apnea, Obstructive

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rakesh Sondekoppam Vijayashankar

OTHER

Sponsor Role: lead

Responsible Party

Rakesh Sondekoppam Vijayashankar

Principle Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Rakesh V. Sondekoppam, MD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

University of Iowa

Iowa City, Iowa, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 24445639 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23257990 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26658438 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25220277 (View on PubMed)

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. doi: 10.1177/000348940911800304.

Reference Type: BACKGROUND

PMID: 19374148 (View on PubMed)

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. doi: 10.1093/sleep/30.11.1503.

Reference Type: BACKGROUND

PMID: 18041482 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23675433 (View on PubMed)

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. doi: 10.1212/wnl.54.9.1872. No abstract available.

Reference Type: BACKGROUND

PMID: 10802805 (View on PubMed)

Other Identifiers

202001068

Identifier Type: -

Identifier Source: org_study_id