Obstructive Sleep Apnea of AdultNCT06447818
Changes in Difficult Airway Markers After Surgery for Obstructive Sleep Apnoea Syndrome
An observational study of Obstructive Sleep Apnea of Adult and Difficult or Failed Intubation, run by Kocaeli City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study investigates the changes in difficult airway markers at 6 months post operatively in patients undergoing obstructive sleep apnoea surgery Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obstructive Sleep Apnea of Adult, Difficult or Failed Intubation
- What is being tested?
- Change in airway markers
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2024to 15 May 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 18-65 years with American society of anaesthesiologist score 1-3 who will undergo obstructive sleep apnoea surgery
Who may be able to join
- Age between 18-65
- American society of assosication score (ASA) :1-3
- To undergo Obstructive sleep apnea surgery (OSAS)
Who cannot join
- Verbal and written consent cannot be obtained
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kocaeli City Hospital
Kocaeli, Izmıt, 41 100
Ahmet Yuksek, M.D., 532 658 03 51, mdayuksek@hotmail.com
About this study
This study investigates the changes in difficult airway markers at 6 months post operatively in patients undergoing obstructive sleep apnoea surgery
Read the 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.
- Being tested
- Change in airway markers
- Keywords
- Obstructive sleep apnea surgery, Difficult airway markers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Change in airway markersOther
Mallampati and cormack lahane scores will be evaluated at the sixth postoperative month
| Study group | Role | What they receive |
|---|---|---|
| Airway groups | This group will consist of patients who will undergo airway surgery for obstructive sleep apnoea Receives: Other: Change in airway markers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: post operative sixth month
Secondary outcomes (2)
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
Measured: post operative sixth month
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
Measured: post operative sixth month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start15 May 2024
- Primary completion1 May 2025 (estimated)
- Study completion15 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnea of AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Kocaeli City Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ayse Sencan, MD, Principal investigator, Kocaeli City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06447818
- Sponsor's protocol ID
- 2024-40
- Status last verified
- Jun 2024
- First submitted
- 20 May 2024
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Sharing of patient data is prohibited by the organisation. If necessary, it can be accessed by obtaining the relevant permissions
Publications
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.
PubMed 27274369Beecham GB, Easton-Carr R. Difficult Airway. 2026 Mar 25. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK470224/
PubMed 29261859Mark 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.
PubMed 26086513
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Difficult Airway Markers After Surgery for Obstructive Sleep Apnoea Syndrome
- ClinicalTrials.gov ID
- NCT06447818
- Acronym / sponsor ID
- 2024-40
- Keywords
- Obstructive sleep apnea surgery, Difficult airway markers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Kocaeli City HospitalOther government
- Study start
- 15 May 2024 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 15 May 2025 (estimated)
- First posted
- 7 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Airway groups | – | Other: Change in airway markersThis group will consist of patients who will undergo airway surgery for obstructive sleep apnoea |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18-65 years with American society of anaesthesiologist score 1-3 who will undergo obstructive sleep apnoea surgery
Key inclusion criteria (3 listed)
- Age between 18-65
- American society of assosication score (ASA) :1-3
- To undergo Obstructive sleep apnea surgery (OSAS)
Key exclusion criteria (1 listed)
- Verbal and written consent cannot be obtained
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Change in airway markersMallampati and cormack lahane scores will be evaluated at the sixth postoperative month | Other | Airway groups |
Primary outcome
Change of Modified mallampati score
Time frame: post operative sixth month
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.
2 secondary outcomes
Sleep quality assesment pre and post operative surgery
Time frame: post operative sixth month
Change of Cormack lahane score
Time frame: post operative sixth month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Background: PubMed 27274369Koh 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.
- Background: PubMed 29261859Beecham GB, Easton-Carr R. Difficult Airway. 2026 Mar 25. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK470224/
- Background: PubMed 26086513Mark 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.
- Individual participant dataSharing planned: No. Sharing of patient data is prohibited by the organisation. If necessary, it can be accessed by obtaining the relevant permissions
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayse Sencan, MD principal investigator
Kocaeli City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea of Adult and Difficult or Failed Intubation, run by Kocaeli City Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayse Sencan, MD (05078313235, draysesencan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Modified mallampati score (time frame: post operative sixth month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06447818, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2024.