Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-25 @ 4:59 AM
NCT ID:
NCT06447818
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.
Study:
NCT06447818
Study Brief:
Protocol Section:
NCT06447818