Changes in Difficult Airway Markers After Surgery for Obstructive Sleep Apnoea Syndrome

NCT06447818 | Recruiting

• 1 other identifier: 2024-40
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the changes in difficult airway markers at 6 months post operatively in patients undergoing obstructive sleep apnoea surgery

Conditions

Obstructive Sleep Apnea of Adult; Difficult or Failed Intubation

Keywords

Obstructive sleep apnea surgery, Difficult airway markers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Sleep quality assesment pre and post operative surgery

  post operative sixth month

• Change of Cormack lahane score

  post operative sixth month

Study Arms (1)

Airway groups

This group will consist of patients who will undergo airway surgery for obstructive sleep apnoea

Other: Change in airway markers

Interventions

Change in airway markers OTHER

Mallampati and cormack lahane scores will be evaluated at the sixth postoperative month

Airway groups

Eligibility Criteria

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

Study Population

Patients aged 18-65 years with American society of anaesthesiologist score 1-3 who will undergo obstructive sleep apnoea surgery

You may qualify if:

• Age between 18-65
• American society of assosication score (ASA) :1-3
• To undergo Obstructive sleep apnea surgery (OSAS)

You may not qualify if:

• Verbal and written consent cannot be obtained

Sponsors & Collaborators

• Kocaeli City Hospital: lead

Study Sites (1)

Kocaeli City Hospital

Kocaeli, Izmıt, 41 100, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• 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.

  PMID: 27274369 BACKGROUND

• Kollmeier BR, Boyette LC, Beecham GB, Desai NM, Khetarpal S. Difficult Airway. 2023 Apr 10. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK470224/

  PMID: 29261859 BACKGROUND

• 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.

  PMID: 26086513 BACKGROUND

Study Officials

• Ayse Sencan, MD

  Kocaeli City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayse Sencan, MD

CONTACT

05078313235; draysesencan@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: June 7, 2024
• Study Start: May 15, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 15, 2025
• Last Updated: June 7, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)