Airway EdemaNCT05197400
Comparison of the Effect of Supine and Prone Position on the Ultrasonographic Airway Measurements
A study testing preoperative airway ultrasonography and postoperative airway ultrasonography in people with Airway Edema and Obstructive Sleep Apnea, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the preoperative and postoperative ultrasonographic measurements of patients undergoing in the prone position and the change in upper airway edema. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Airway Edema, Obstructive Sleep Apnea, Respiratory Complication
- What is being tested?
- preoperative airway ultrasonography and postoperative airway ultrasonography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2022to 1 Jul 2022
- Phase
- Interventional
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- prone position contraindications
- history of maxillofacial deformity, tumor or trauma,
- difficult airway history
- decompensated cardiac, respiratory, hepatic, renal diseases
- cervical spine fracture
- Patients refusal -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Comparison of the Effect of Supine and Prone Position on the Ultrasonographic Upper Airway Measurements and Postoperative Critical Respiratory Events
The aim of this study is to compare the preoperative and postoperative ultrasonographic measurements of patients undergoing in the prone position and the change in upper airway edema.
The secondary aim of the study is to investigate the relationship between OSAS risk levels determined by the STOP-BANG score in the preoperative period of the patients participating in the study, and airway ultrasound measurements and postoperative critical respiratory events in the preoperative and postoperative period.
- Being tested
- preoperative airway ultrasonography, postoperative airway ultrasonography
- Keywords
- airway edema, obstructive sleep apnea, respiratory complications
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preoperative airway ultrasonographyDiagnostic test
Tongue thickness Median sagittal tongue cross-sectional area Tongue width
Tongue volume:
Lateral parapharyngeal wall thickness
postoperative airway ultrasonographyDiagnostic test
Tongue thickness Median sagittal tongue cross-sectional area Tongue width
Tongue volume:
Lateral parapharyngeal wall thickness
| Study group | Role | What they receive |
|---|---|---|
| supine | Active comparator | operation in the supine position Receives: Diagnostic Test: preoperative airway ultrasonography; Diagnostic Test: postoperative airway ultrasonography |
| prone | Active comparator | operation in the prone position Receives: Diagnostic Test: preoperative airway ultrasonography; Diagnostic Test: postoperative airway ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative Tongue thickness
Measured: Baseline, preoperative
postoperative Tongue thickness1
Measured: postextubation
postoperative Tongue thickness2
Measured: postoperative 2. hour]
preoperative Tongue volume
Measured: Baseline, preoperative
postoperative Tongue volume1
Measured: postextubation
postoperative Tongue volume2
Measured: postoperative 2. hour
Preoperative Lateral parapharyngeal wall thickness
Measured: Baseline, preoperative
postoperative Lateral parapharyngeal wall thickness1
Measured: postextubation
postoperative Lateral parapharyngeal wall thickness2
Measured: postoperative 2. hour
Critical respiratory events
Measured: Within postoperative 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start1 Feb 2022
- Primary completion1 May 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway EdemaStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Işıl Karabeyoğlu, Ankara City Hospital Bilkent
- Investigators
- ışıl karabeyoğlu, md, Principal investigator, ankara ch bilkentbetül güven aytaç, Study chair, Ankara CH bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05197400
- Sponsor's protocol ID
- E1-21-2261
- Status last verified
- Jan 2023
- First submitted
- 5 Jan 2022
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Comparison of the Effect of Supine and Prone Position on the Ultrasonographic Upper Airway Measurements and Postoperative Critical Respiratory Events
- ClinicalTrials.gov ID
- NCT05197400
- Acronym / sponsor ID
- E1-21-2261
- Keywords
- airway edema, obstructive sleep apnea, respiratory complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 19 Jan 2022 (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.
The aim of this study is to compare the preoperative and postoperative ultrasonographic measurements of patients undergoing in the prone position and the change in upper airway edema.
The secondary aim of the study is to investigate the relationship between OSAS risk levels determined by the STOP-BANG score in the preoperative period of the patients participating in the study, and airway ultrasound measurements and postoperative critical respiratory events in the preoperative and postoperative period.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| supine | Active comparator | Diagnostic Test: preoperative airway ultrasonography, Diagnostic Test: postoperative airway ultrasonographyoperation in the supine position |
| prone | Active comparator | Diagnostic Test: preoperative airway ultrasonography, Diagnostic Test: postoperative airway ultrasonographyoperation in the prone position |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- prone position contraindications
- history of maxillofacial deformity, tumor or trauma,
- difficult airway history
- decompensated cardiac, respiratory, hepatic, renal diseases
- cervical spine fracture
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 |
|---|---|---|
| preoperative airway ultrasonographyTongue thickness Median sagittal tongue cross-sectional area Tongue width Tongue volume: Lateral parapharyngeal wall thickness | Diagnostic test | prone, supine |
| postoperative airway ultrasonographyTongue thickness Median sagittal tongue cross-sectional area Tongue width Tongue volume: Lateral parapharyngeal wall thickness | Diagnostic test | prone, supine |
Primary outcome
Preoperative Tongue thickness
Time frame: Baseline, preoperative
postoperative Tongue thickness1
Time frame: postextubation
postoperative Tongue thickness2
Time frame: postoperative 2. hour]
preoperative Tongue volume
Time frame: Baseline, preoperative
postoperative Tongue volume1
Time frame: postextubation
postoperative Tongue volume2
Time frame: postoperative 2. hour
Preoperative Lateral parapharyngeal wall thickness
Time frame: Baseline, preoperative
postoperative Lateral parapharyngeal wall thickness1
Time frame: postextubation
postoperative Lateral parapharyngeal wall thickness2
Time frame: postoperative 2. hour
Critical respiratory events
Time frame: Within postoperative 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Individual participant dataSharing planned: No
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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.
ışıl karabeyoğlu, md principal investigator
ankara ch bilkent
betül güven aytaç study chair
Ankara CH bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing preoperative airway ultrasonography and postoperative airway ultrasonography in people with Airway Edema and Obstructive Sleep Apnea, run by Ankara City Hospital Bilkent 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 0 inclusion and 6 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: finished, as of the sponsor's last update on 15 Jan 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative Tongue thickness (time frame: Baseline, preoperative). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jan 2025.