Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06447818
Status:
RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-05-20
Brief Title:
Changes in Difficult Airway Markers After Surgery for Obstructive Sleep Apnoea Syndrome
Sponsor:
Kocaeli City Hospital
Organization:
Kocaeli City Hospital
Study Overview
Official Title:
Changes in Difficult Airway Markers After Surgery for Obstructive Sleep Apnoea Syndrome
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 sleepAnaesthesia 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 operationfollow-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 publicationsOur study will be conducted in prospective observational status Within the study period 01052024-01052025 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
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 sleepAnaesthesia 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 operationfollow-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 publicationsOur study will be conducted in prospective observational status Within the study period 01052024-01052025 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None