Ultrasound Versus Clinical Tests as Predictors of Difficult Endotracheal Intubation in Patients With Obstructive Sleep Apnoea Undergoing Elective Surgery Under General Anaesthesia

Obstructive sleep apnoea (OSA) is the most serious kind of the sleep-disordered breathing group, characterised by recurrent episodes of partial to complete obstruction of the upper airway resulting in inefficient alveolar gas exchange and desaturation[1].

It is a commonly encountered condition with a reported prevalence of 9-25% in the general population [2].

However, the majority of OSA patients presenting for surgery remain undiagnosed or untreated[3], contributing to a high rate of unexpected adverse airway outcome[4].

The various airway abnormalities represented by OSA include a large tongue, collapsible airway and crowding of the oropharyngeal structures, among others[5].

Accurate airway assessment should always be performed so as to provide appropriate planning and management of expected difficult intubation, but the common clinical screening tests (Mallampati score, inter-incisor distance, mento-hyoid distance, BMI, etc ) have shown low sensitivity and specificity with a limited predictive value, especially if only a single assessment method is used[6].

Ultrasonography could be a highly sensitive and specific tool for prediction of difficult intubation in OSA patients presented for elective surgery by measuring tongue base thickness, distance between lingual arteries, hyo-mental distance and condylar mobility.

Study Overview

• Status: Recruiting
• Conditions: Difficult Intubation in Obstructive Sleep Apnea

• Study Type: Observational
• Enrollment (Anticipated): 70

Contacts and Locations

• Study Contact: Name: Amer AB Soliman, bachelor; Phone Number: 0201094963127; Email: amer.soliman0@gmail.com

Study Locations

• Egypt
  • Gharbya
    • Tanta, Gharbya, Egypt
      • Recruiting
      • Tanta University Hospitals
      • Contact: Amer AB Soliman, bachelor; Phone Number: 0201094963127; Email: amer.soliman0@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

This study will be carried out on OSA patients prepared for elective surgery under general anaesthesia with tracheal intubation from Tanta University Hospitals

Description

Inclusion Criteria:

1. 21-60 years old
2. ASA I, II, or III
3. STOP-BANG scoring >3

Exclusion Criteria:

• 1) Age <21 years old 2) patients with cervical spine injury, limited neck mobility, neck swelling 3) patients with lost incisor teeth 4) asymmetric mobility of the temporomandibular joint as in maxillofacial injuries/malignancies prior to surgery on the airway 5) pregnancy

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ultrasound parameters	evaluate the accuracy of the ultrasound parameters as predictors of difficult intubation in OSA patients in the perioperative period.	preoperative assessment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
which is better	- To evaluate which is superior for assessment of difficult intubation in OSA patients, ultrasound or clinical tests.	preoperative assessment

Collaborators and Investigators

• Sponsor: Tanta University
• Investigators: Principal Investigator: Amer AB Soliman, Bachelor, Tanta University Hospitals

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2022
• Primary Completion (Anticipated): January 31, 2023
• Study Completion (Anticipated): January 31, 2023

Study Registration Dates

• First Submitted: May 27, 2022
• First Submitted That Met QC Criteria: May 28, 2022
• First Posted (Actual): June 2, 2022

Study Record Updates

• Last Update Posted (Actual): June 2, 2022
• Last Update Submitted That Met QC Criteria: May 28, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 35152/12/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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