Point of Care Ultrasound in Pregnant Women (PoCUS-OB)

Point of Care Ultrasound (PoCUS) as a Tool to Evaluate Patients at High Risk of Obstructive Sleep Apnea in the Obstetric Population

Pregnant women with gestational age more than 20 weeks are at risk of developing Obstructive Sleep Apnea (OSA). OSA is a common underdiagnosed comorbid condition in pregnant women associated with adverse maternal and fetal outcomes. It is a severe form of sleep-disordered breathing (SDB), featured with repeated episodes of airflow reduction or cessation during sleep. It exists in different severity among pregnant women and maybe worsen over the course of the pregnancy. If OSA remains untreated, it can complicate the pregnancy by developing heart failure, gestational diabetes, pre-eclampsia, eclampsia, and hypertension. To determine the OSA during pregnancy has become an important issue to reduce the morbidity related to it. Currently, Polysomnography (PSG) remains the gold standard for diagnosing OSA, but scheduling and logistics remain significant impediments to accessibility for pregnant women. Home sleep apnea tests (HST) is a promising alternative but are expensive and not widely available. Point of care ultrasonography (PoCUS) is being increasingly used across specialties. Our preliminary data support the feasibility of PoCUS in the preoperative setting and increasing the diagnostic accuracy and the specificity for moderate to severe OSA (AHI >15 events per h) when combined with the STOP-Bang questionnaire (cut-off >5). Given that HST shows high levels of agreement with PSG for the diagnosis of OSA and are significantly less burdensome than PSG, investigators will evaluate the PoCUS airway examination against the HST for the diagnosis of OSA in pregnant women at high risk of OSA.

Study Overview

• Status: Not yet recruiting
• Conditions: Obstructive Sleep Apnea (OSA)
• Intervention / Treatment: Diagnostic test: PoCUS

Detailed Description

This project is to define the range of mouth and tongue dimensions and to visualize airway structures by using ultrasound. Given that Home sleep apnea tests (HST) shows high levels of accuracy for the diagnosis of Obstructive sleep apnea (OSA), investigators hypothesize that the Point of care ultrasonography (PoCUS) airway examination against the HST for the diagnosis of OSA in pregnant women at the high-risk can,

1. reliably visualize upper airway structures that are responsible for OSA;
2. objectively measure airway soft tissue thickness and dimensions; and
3. identify pregnant women with moderate-severe OSA.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Abdel Basit Al Hawwari; Phone Number: 3959 4166035800; Email: abdelbasit.alhawwari@uhn.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T 2S8
      • Toronto Western Hospital (TWH)-University Health Network (UHN)
      • Contact: Abdel Basit Al Hawwari, MSN, RN; Phone Number: 3959 4166035800; Email: abdelbasit.alhawwari@uhn.ca
      • Principal Investigator: Mandeep Singh, MBBS, FRCPC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Investigators aim to recruit 100 pregnant women ≥ 18 years of age at > 20 weeks of gestation, ASA physical status I - IV, with untreated recently diagnosed (within the previous 12 months) OSA or at high risk of OSA

Description

- Inclusion criteria

• Pregnant women ≥ 18 years of age
• at > 20 weeks of gestation
• ASA physical status I - IV
• With untreated recently diagnosed (within the previous 12 months) OSA or at high risk of OSA will be eligible for inclusion.

High risk of OSA will be defined as outlined by Facco et al. and recommended by recently updated guidelines (i.e., score ≥ 75) (8).

- Exclusion criteria i) past history of oral, head or neck surgery (e.g., corrective surgery for OSA) ii) active head and neck disease (e.g., cancer, infection, radiotherapy etc.) iii) inability to perform HST per instruction iv) patients with diagnosed OSA on CPAP therapy

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Areas Under the Curve (AUC)	The primary outcome will be the difference in Areas Under the Curve (AUC) for each US parameter compared to the AUC of the HST obtained using the Receiver Operating Characteristic (ROC) curves for moderate to severe OSA defined as AHI > 15.	One Day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The inter-rater reliability for measuring each one of the airway parameters	i) The inter-rater reliability for measuring each one of the airway parameters ii) The association between each US parameter and OSA severity level (none/mild/moderate/severe) iii) The association between each US parameter and OSA diagnosis derived from PSG	One Day

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: MOUNT SINAI HOSPITAL
• Investigators: Principal Investigator: Mandeep Singh, MD, University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: January 9, 2025
• First Submitted That Met QC Criteria: January 9, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 15, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: OSA,Pregnancy,Women,HST,Ultrasound
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: 23-5451

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No