Obstructive Sleep Apnea of Adult Clinical Trial
Official title:
Changes in Difficult Airway Markers After Surgery for Obstructive Sleep Apnoea Syndrome
NCT number | NCT06447818 |
Other study ID # | 2024-40 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 15, 2024 |
Est. completion date | May 15, 2025 |
This study investigates the changes in difficult airway markers at 6 months post operatively in patients undergoing obstructive sleep apnoea surgery
Status | Recruiting |
Enrollment | 42 |
Est. completion date | May 15, 2025 |
Est. primary completion date | May 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Age between 18-65 - American society of assosication score (ASA) :1-3 - To undergo Obstructive sleep apnea surgery (OSAS) Exclusion Criteria: - Verbal and written consent cannot be obtained |
Country | Name | City | State |
---|---|---|---|
Turkey | Kocaeli City Hospital | Kocaeli | Izmit |
Lead Sponsor | Collaborator |
---|---|
Kocaeli City Hospital |
Turkey,
Koh W, Kim H, Kim K, Ro YJ, Yang HS. Encountering unexpected difficult airway: relationship with the intubation difficulty scale. Korean J Anesthesiol. 2016 Jun;69(3):244-9. doi: 10.4097/kjae.2016.69.3.244. Epub 2016 Jun 1. — View Citation
Kollmeier BR, Boyette LC, Beecham GB, Desai NM, Khetarpal S. Difficult Airway. 2023 Apr 10. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK470224/ — View Citation
Mark LJ, Herzer KR, Cover R, Pandian V, Bhatti NI, Berkow LC, Haut ER, Hillel AT, Miller CR, Feller-Kopman DJ, Schiavi AJ, Xie YJ, Lim C, Holzmueller C, Ahmad M, Thomas P, Flint PW, Mirski MA. Difficult airway response team: a novel quality improvement program for managing hospital-wide airway emergencies. Anesth Analg. 2015 Jul;121(1):127-139. doi: 10.1213/ANE.0000000000000691. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of Modified mallampati score | Modified mallampati score is one of the difficult airway markers evaluated preoperatively When the mouth is opened and the tongue is protruded Grade 1:soft palate, uvula, plicae and tonsils are clearly visible Grade 2:The soft palate, uvula, plicae and upper pole of the tonsils are visible.
Grade 3: only the soft palate and part of the palate can be seen. Grade 4:only the hard palate can be seen. |
post operative sixth month | |
Secondary | Sleep quality assesment pre and post operative surgery | Eppworth sleepiness test (ESS) The ESS subjectively measures sleepiness as it occurs in ordinary life situations.It can be used to screen for excessive sleepiness or to follow an individual's subjective response to an intervention.
Eight situations are described on a questionnaire: Sitting and reading Watching television Sitting inactively in a public place Riding as a passenger in a car for one hour without a break Lying down to rest in the afternoon when circumstances permit Sitting and talking with someone Sitting quietly after lunch without alcohol Sitting in a car as the driver, while stopped for a few minutes in trafficEach situation receives a score of 0 to 3, which is related to the likelihood that sleep will be induced: 0 = would never doze 1 = slight chance of dozing 2 = moderate chance of dozing 3 = high chance of dozing Total ESS score can range from 0 to 24, with higher scores correlating with increasing degrees of sleepiness |
post operative sixth month | |
Secondary | Change of Cormack lahane score | Cor Mack Lahane Score:The Cormack-Lehane scale describes the best view of the glottis during laryngoscopy, with grades defined by the structures that can be seen, as follows:
Grade 1 - Most of the glottis Grade 2 - Only the posterior extremity of the glottis Grade 3 - Only the epiglottis Grade 4 - Neither the glottis nor the epiglottis |
post operative sixth month |
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