Clinical trial NCT06447818: Changes in Difficult Airway Markers After Surgery for Obstructive Sleep Apnoea Syndrome
Official title: Changes in Difficult Airway Markers After Surgery for Obstructive Sleep Apnoea Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obstructive Sleep Apnea of Adult
Difficult or Failed Intubation
Keywords: Obstructive sleep apnea surgery, Difficult airway markers
Lead sponsor: Kocaeli City Hospital
Sponsor class: OTHER_GOV
First posted: 2024-06-07
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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

Detailed description: The incidence of difficult airway is approximately one in 1000 cases and it is a life-threatening condition in perioperative patients. Many classifications, guidelines and appæroaches have been proposed to recognise patients with difficult airway. Even the most well-known classifications are not 100% successful in predicting difficult airway . For this reason, some unexpected difficult airway cases are encountered and their management is the subject of new research in the literature .

Obstructive sleep apnoea syndrome (OSAS) is associated with the possibility of difficult airway. Perioperative airway complications may also increase in patients with OSAS. Complications related with cardiac, pulmonary, endocrine and other systems are observed in patients living with a diagnosis of OSAS for a long time. The rate of complications is increased especially in patients with prolonged apnoea episodes during sleep.Anaesthesia process also poses a risk for OSAS patients. In patients receiving positive airway pressure therapy at home, intensive care or close anaesthesia is required at the end of the operation.follow-up is applied. In addition, OSAS patients are suitable candidates for day surgery, which is increasing day by day.

Reducing the symptoms with surgical treatment before OSAS is complicated can also reduce the effects that may occur in the future. Surgeries such as anterior uvulopalatinoplasty are frequently performed in these patients. OSAS patients require close follow-up and evaluation in terms of anaesthesia before these surgeries. A decrease in symptoms after surgery has been shown in some publications.Our study will be conducted in prospective observational status. Within the study period (01.05.2024-01.05.2025), patients who will undergo OSAS surgery by the ENT clinic in our operating theatres in a 12-month period will be included. In the preoperative evaluation of these patients; STOP-BANG and Epworth sleepiness test, SF-12 quality of life scales and laboratory values, if any, echocardiography results will be collected.

Weight, mallampati scores, neck circumference, thyromental distances and demographic data will be recorded at the preoperative visit.

After induction of anaesthesia, parameters such as mask ventilation, difficulty in laryngoscopy and intubation, Cormack-Lehane scores on direct laryngoscopy and the need for advanced airway techniques will be recorded.

At the end of the operation, the type of surgery performed and the need for intensive care will be recorded.

Patients will be routinely awakened and extubated at the end of the operation and discharged home with routine procedures after follow-up in the ward. Due to its observational status, no changes will be applied in the perioperative processes of our study patients.

Epworth sleepiness score questionnaire (Epworth Sleepness score), SF-12 quality of life questionnaire and STOP-BANG scores, mallampati score, cormack- lahane score, weight and neck circumference measurements will be taken again when the patients come to the control for surgery in the sixth postoperative month.

The changes of these values compared to preoperative values will be analysed at the sixth month after the study.

Eligibility criteria: 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

Primary outcomes:
measure: Change of Modified mallampati score
timeFrame: post operative sixth month
Secondary outcomes:
measure: Sleep quality assesment pre and post operative surgery
timeFrame: post operative sixth month
measure: Change of Cormack lahane score
timeFrame: post operative sixth month
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli City Hospital
state: Izmıt
Study officials:
affiliation: Kocaeli City Hospital
name: Ayse Sencan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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/
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.