To examine upper breathing route in people suffering from sleep related breathing disorders using sonography.

Recruiting

• Conditions: Sleep apnea,

• Registration Number: CTRI/2022/07/044431
• Lead Sponsor: PGIMER

Brief Summary

Now-a-days, airway ultrasonography (USG) is commonly used as a screening tool owing to wide availability, less expensive, portable, radiation free, and comfortable for patients. Submental USG has been studied as a dynamic, safe method, permitting the noninvasive visualization of soft-tissue structures of airway. we plan to conduct the prospective observational trial to evaluate the anatomic features and the dynamic changes of pharyngeal airspace by submental USG to identify OSA severity. We also plan to study the correlation between USG findings with DISE findings. The primary aim of the study is to assess percentage change in retropalatal diameter during Muller’s maneuver for predicting severe OSA in adults.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-08
• Last Update Posted: 2022-08-08

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Diagnosed OSA patients (as scheduled for DISE procedure), 2.
• American Society of Anaesthesiologists physical status (ASA-PS) I and II, 3.
• Between 18-65 years of age of either gender.

Exclusion Criteria

• Patient’s refusal; 2.
• Inability to perform maneuvers as per study protocol; 3.
• History of syndromic craniofacial abnormalities (e.g., Down syndrome); 4.
• Burns, trauma or radiotherapy involving the head and neck region; 5.
• Limited neck movements; 6.
• Prior upper airway surgery; 7.
• Upper airway masses/tumors; or 8.
• Neuromuscular disorders other than OSA.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess percentage change in the retropalatal diameter during Muller’s maneuver for predicting severe OSA.	Baseline (pre drug induced sleep endoscopy procedure)

Secondary Outcome Measures

Name	Time	Method
-To assess	1. Percentage change in the tongue base thickness during Muller’s manoeuvre,
-To correlate the dynamic airway ultrasound findings with the corresponding anatomical level findings in DISE	Baseline ultrasonography and DISE findings at the end of DISE procedure

Trial Locations

Locations (1)

Nehru hospital extension block; 🇮🇳 Chandigarh, CHANDIGARH, India

Nehru hospital extension block

🇮🇳Chandigarh, CHANDIGARH, India

Dr Abhishek Paul Moses

Principal investigator

9944725512

abhishekmoses@gmail.com