Side EffectNCT04205253
Tongue Depressor-related Ischemia-Reperfusion Injury in Tongue
An observational study of Side Effect and Ischemia Reperfusion Injury, run by Selcuk University at 2 sites in Turkey (Türkiye).
Trial summary
This study aimed to detect tongue edema associated with the pressure exerted by a rigid direct laryngoscope by measuring the tongue area using USG in patients undergoing suspension laryngoscopy (SL) procedures. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Side Effect, Ischemia Reperfusion Injury, Edema
- What is being tested?
- Ultrasonography imaging
- How many people
- 64 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Oct 2018to 1 Apr 2019
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 20 years or older who will undergo suspension laryngoscopy procedures or who did not need suspension larygoscopy procedures.
Who may be able to join
- Patients aged 20 years or older
- Patients who undergo suspension laryngoscope procedure
- Patients aged 20 years or older Patients who did not need suspension laryngoscopy and any head and neck procedures
Who cannot join
- refusal to participate
- age of <20 years
- history of syndromal craniofacial abnormalities
- occurrence of tongue masses
- history of craniofacial surgery
- history of burns, trauma or radiotherapy involving the head and neck region
Show all 10Show fewer
- neurologic disorders and patients with obstructive sleep apnea syndrome (OSAS)
- active inflammation in the head and neck region
- cervical rigidity limiting neck flexion and head extension
- Control group
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Selcen Celik
Konya, Selcuklu, 42100
Selcuk University
Konya, Selcuklu, 42100
About this study
Official title: Is it Possible That Direct Rigid Laryngoscope-related Ischemia-Reperfusion Injury Occurs in the Tongue During Suspension Laryngoscopy as Detected by Ultrasonography: A Prospective Controlled Study
This study aimed to detect tongue edema associated with the pressure exerted by a rigid direct laryngoscope by measuring the tongue area using USG in patients undergoing suspension laryngoscopy (SL) procedures.
Read the detailed description
Suspension laryngoscopy (SL) is a surgical procedure for both diagnostic and therapeutic purposes. In this procedure, a rigid direct laryngoscope is inserted orally, and the tongue and the base of the tongue are compressed.The tongue is an ideal organ for evaluation with ultrasonography. This study aimed to detect the occurrence of tongue edema through ultrasonography examination due to the rigid direct laryngoscope in SL procedures.
- Conditions
- Side Effect, Ischemia Reperfusion Injury, Edema, Tongue Enlarged
- Being tested
- Ultrasonography imaging
- Keywords
- tongue, ischemia-reperfusion injury, side effect, edema, suspension laryngoscopy
- Medical subject headings
- Reperfusion Injury, Edema, Macroglossia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonography imagingDiagnostic test
This study aimed to evaluate the tongue areas and compare the tongue areas before the implementation of rigid direct laryngoscope and after the rigid direct laryngoscope.
| Study group | Role | What they receive |
|---|---|---|
| Study | The first group is the study group. Patients aged 20 years or older and were to undergo suspension laryngoscopy procedure were eligible for inclusion in this group. Tongue areas were measured twice by submental USG. The first measurements (TA1) were done immediately after endotracheal intubation before introducing the rigid direct laryngoscope, whereas the second measurements (TA2) were done after the SL procedure and after removing the rigid direct laryngoscope just before extubation.The difference between TA2 and TA1 (i.e., TA2-TA1) were used to define the occurrence of tongue edema as study group. Receives: Diagnostic Test: Ultrasonography imaging | |
| Control | The second group was the control group, which included patients who did not need SL and any head and neck procedures.The tongue areas of these patients were measured twice by submental USG as in the study group. The TA1 measurements were done immediately after endotracheal intubation, whereas the TA2 measurements were done at the end of the surgical procedure just before extubation. The difference between TA2 and TA1 (i.e., TA2-TA1) were used to define the occurrence of tongue edema as study group. Receives: Diagnostic Test: Ultrasonography imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of change in tongue area.
This study aimed to measure the change in tongue areas before and after the implementation of rigid direct laryngoscope by using ultrasonography imaging.
Measured: 2018-2019 (6 months)
Secondary outcomes (1)
Rate of formation in tongue edema.
This study aimed to measure the formation of tongue edema due to the rigid direct laryngoscope by using ultrasonography imaging.
Measured: 2018 (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2019
- Study start1 Oct 2018
- Primary completion1 Apr 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Side EffectStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozkan Onal, Selcuk University
- Investigators
- Ozkan Onal, Professor, Principal investigator, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04205253
- Sponsor's protocol ID
- 2018/330
- Status last verified
- Dec 2019
- First submitted
- 17 Dec 2019
- Last updated
- 19 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data has been planned to share after publishing as a article in a journal.
Publications
Onal M, Colpan B, Elsurer C, Bozkurt MK, Onal O, Turan A. Is it possible that direct rigid laryngoscope-related ischemia-reperfusion injury occurs in the tongue during suspension laryngoscopy as detected by ultrasonography: a prospective controlled study. Acta Otolaryngol. 2020 Jul;140(7):583-588. doi: 10.1080/00016489.2020.1743353. Epub 2020 Mar 30.
PubMed 32223688
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is it Possible That Direct Rigid Laryngoscope-related Ischemia-Reperfusion Injury Occurs in the Tongue During Suspension Laryngoscopy as Detected by Ultrasonography: A Prospective Controlled Study
- ClinicalTrials.gov ID
- NCT04205253
- Acronym / sponsor ID
- 2018/330
- Conditions
- Side Effect, Ischemia Reperfusion Injury, Edema, Tongue Enlarged
- Keywords
- tongue, ischemia-reperfusion injury, side effect, edema, suspension laryngoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 19 Dec 2019 (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 aimed to detect tongue edema associated with the pressure exerted by a rigid direct laryngoscope by measuring the tongue area using USG in patients undergoing suspension laryngoscopy (SL) procedures.
Detailed description
Suspension laryngoscopy (SL) is a surgical procedure for both diagnostic and therapeutic purposes. In this procedure, a rigid direct laryngoscope is inserted orally, and the tongue and the base of the tongue are compressed.The tongue is an ideal organ for evaluation with ultrasonography. This study aimed to detect the occurrence of tongue edema through ultrasonography examination due to the rigid direct laryngoscope in SL procedures.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study | – | Diagnostic Test: Ultrasonography imagingThe first group is the study group. Patients aged 20 years or older and were to undergo suspension laryngoscopy procedure were eligible for inclusion in this group. Tongue areas were measured twice by submental USG. The first measurements (TA1) were done immediately after endotracheal intubation before introducing the rigid direct laryngoscope, whereas the second measurements (TA2) were done after the SL procedure and after removing the rigid direct laryngoscope just before extubation.The difference between TA2 and TA1 (i.e., TA2-TA1) were used to define the occurrence of tongue edema as study group. |
| Control | – | Diagnostic Test: Ultrasonography imagingThe second group was the control group, which included patients who did not need SL and any head and neck procedures.The tongue areas of these patients were measured twice by submental USG as in the study group. The TA1 measurements were done immediately after endotracheal intubation, whereas the TA2 measurements were done at the end of the surgical procedure just before extubation. The difference between TA2 and TA1 (i.e., TA2-TA1) were used to define the occurrence of tongue edema as study group. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 20 years or older who will undergo suspension laryngoscopy procedures or who did not need suspension larygoscopy procedures.
Key inclusion criteria (3 listed)
- Patients aged 20 years or older
- Patients who undergo suspension laryngoscope procedure
- Patients aged 20 years or older Patients who did not need suspension laryngoscopy and any head and neck procedures
Key exclusion criteria (10 listed)
- refusal to participate
- age of <20 years
- history of syndromal craniofacial abnormalities
- occurrence of tongue masses
- history of craniofacial surgery
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 |
|---|---|---|
| Ultrasonography imagingThis study aimed to evaluate the tongue areas and compare the tongue areas before the implementation of rigid direct laryngoscope and after the rigid direct laryngoscope. | Diagnostic test | Control, Study |
Primary outcome
Rate of change in tongue area.
Time frame: 2018-2019 (6 months)
This study aimed to measure the change in tongue areas before and after the implementation of rigid direct laryngoscope by using ultrasonography imaging.
1 secondary outcome
Rate of formation in tongue edema.
Time frame: 2018 (6 months)
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 19 Dec 2019.
- Derived from this study: PubMed 32223688Onal M, Colpan B, Elsurer C, Bozkurt MK, Onal O, Turan A. Is it possible that direct rigid laryngoscope-related ischemia-reperfusion injury occurs in the tongue during suspension laryngoscopy as detected by ultrasonography: a prospective controlled study. Acta Otolaryngol. 2020 Jul;140(7):583-588. doi: 10.1080/00016489.2020.1743353. Epub 2020 Mar 30.
- Individual participant dataSharing planned: No. Individual participant data has been planned to share after publishing as a article in a journal.
Related trials for Side Effect
Active, not recruitingPhase 2
A Study of Anakinra to Prevent or Treat Severe Side Effects for Patients Receiving CAR-T Cell Therapy
B Cell ALL, B-Cell Lymphoma
Not yet recruitingPhase 2
SAMe in Prevention of Oxaliplatin-associated Liver Injury
Colorectal Cancer, Liver Metastases
Not yet recruitingPhase 2
The CARDIOPROTECT Trial
Diffuse Large B-cell Lymphoma (DLBCL), Cardiotoxicity
RecruitingPhase 4
Hematological Safety of Dipyrone Versus Paracetamol After Dental Extractions
Hematologic Test, Agranulocytosis
RecruitingObservational study
Predictive Factors for Occlusal Changes in Obstructive Sleep Apnea Treatment With Mandibular Advancement Appliance
Obstructive Sleep Apnea Syndrome
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.
Ozkan Onal, Professor principal investigator
Selcuk University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Side Effect and Ischemia Reperfusion Injury, run by Selcuk University at 2 sites 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 10 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 19 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Rate of change in tongue area. (time frame: 2018-2019 (6 months)). 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 NCT04205253, which also lists 1 linked publication.
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 19 Dec 2019.