Point-of-care-Ultrasound for Sleep Apnea

NCT04443582 | Completed

• 1 other identifier: 202001068
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea, Obstructive

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting for surgeries who meet eligibility criteria.

You may qualify if:

• Patients of either gender
• Age 18 through 85
• History of previous sleep study polysomnography (PSG)

You may not qualify if:

• 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

Sponsors & Collaborators

• Rakesh Sondekoppam Vijayashankar: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Related Publications (8)

• 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.

  PMID: 24445639 BACKGROUND

• 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.

  PMID: 23257990 BACKGROUND

• 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.

  PMID: 26658438 BACKGROUND

• 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.

  PMID: 25220277 BACKGROUND

• 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.

  PMID: 19374148 BACKGROUND

• 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.

  PMID: 18041482 BACKGROUND

• 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.

  PMID: 23675433 BACKGROUND

• 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.

  PMID: 10802805 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Rakesh V. Sondekoppam, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: June 19, 2020
• First Posted: June 23, 2020
• Study Start: June 10, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: February 28, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)