Tongue EdemaNCT05249738
Tongue Edema Caused by Intubation Tube in Intensive Care Unit Patients
An observational study of Tongue Edema and Tongue Enlarged, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
Tongue edema (TE) is an enlargement of the tongue that can be noticed with the naked eye and protrudes from the mouth. Endotracheal intubation tube, which can exert high pressure on the tongue for a long time, may cause TE. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tongue Edema, Tongue Enlarged, Mechanical Ventilation Complication
- What is being tested?
- Measuring tongue cross-sectional area by submental ultrasonography
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2019to 1 Mar 2020
- 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 who underwent endotracheal intubation in the Anesthesiology and Reanimation intensive care unit were followed up on a mechanical ventilator were included in the study after obtaining informed consent from their legal representatives.
Who may be able to join
- Patients aged between 18-65 years Patients who underwent endotracheal intubation and were admitted to the intensive care unit on the 0th day of intubation and patients who underwent endotracheal intubation during follow-up in the intensive care unit and were followed up on a mechanical ventilator -
Who cannot join
- Patients under the age of 18 and over the age of 65 Patients who had a history of maxillofacial trauma, tongue surgery, head and neck malignancy, radiotherapy to the head and neck region, congenital anomalies of the tongue base and floor of the mouth Patients who were admitted to the intensive care unit due to allergy-anaphylaxis
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Detection of Tongue Edema Caused by Intubation Tube in Intensive Care Unit Patients by Ultrasonography
Tongue edema (TE) is an enlargement of the tongue that can be noticed with the naked eye and protrudes from the mouth. Endotracheal intubation tube, which can exert high pressure on the tongue for a long time, may cause TE. This study was aimed to detect TE, which may develop due to long-term pressure application of the intubation tube to the tongue, in patients hospitalized in the intensive care unit (ICU) who underwent endotracheal intubation by submental ultrasonography (USG) method.
Read the detailed description
Tongue edema (TE) is an enlargement of the tongue that can be noticed with the naked eye and protrudes from the mouth. Endotracheal intubation tube, which can exert high pressure on the tongue for a long time, may cause TE. This study was aimed to detect TE, which may develop due to long-term pressure application of the intubation tube to the tongue, in patients hospitalized in the intensive care unit (ICU) who underwent endotracheal intubation by submental ultrasonography (USG) method.
- Conditions
- Tongue Edema, Tongue Enlarged, Mechanical Ventilation Complication, Intubation Complication
- Being tested
- Measuring tongue cross-sectional area by submental ultrasonography
- Keywords
- ultrasonography, endotracheal intubation tube, complication, drugs, tongue edema
- Medical subject headings
- Macroglossia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measuring tongue cross-sectional area by submental ultrasonographyDiagnostic test
The tongue cross-sectional areas of both groups were measured with submental ultrasonography to detect tongue edema.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Patients followed up with a mechanical ventilator for 4 days or longer were included in the study group. Receives: Diagnostic Test: Measuring tongue cross-sectional area by submental ultrasonography | |
| Control Group | Patients followed up with mechanical ventilation for 3 days or less were included in the control group. Receives: Diagnostic Test: Measuring tongue cross-sectional area by submental ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of tongue edema by ultrasonography
Primary outcome was tongue edema which is likely to develop due to the pressure exerted by endotracheal intubation tube on the tongue, by submental ultrasonography in patients who were followed up on mechanical ventilation for a long time.
Measured: The patients' tongue cross-sectional areas were measured by submental ultrasonograph on the 0th day of endotracheal intubation and 4th day of follow-up on a mechanical ventilator. The difference between the two measurements was evaluated as tongue edema.
Secondary outcomes (1)
The effect of drugs applied in the intensive care unit on the development of tongue edema
Secondary outcome was tongue edema which is likely to develop due to the drugs applied in the intensive care unit by submental ultrasonography.
Measured: The patients' tongue cross-sectional areas were measured by submental ultrasonograph on the 0th day of endotracheal intubation and 4th day of follow-up on a mechanical ventilator. The difference between the two measurements was evaluated as tongue edema.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2022
- Study start15 Oct 2019
- Primary completion1 Mar 2020
- Study completion1 Mar 2020
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 Tongue EdemaStudies 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
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozkan Onal, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05249738
- Sponsor's protocol ID
- 02.10.2019-241
- Status last verified
- Feb 2022
- First submitted
- 11 Feb 2022
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Study protocol, statistical analysis plan and raw data can be shared individual if there is a valid reason.
Publications
Onal M, Colpan B, Elsurer C, Bozkurt MK, Ozturk M, Onal O, Turan A. Can Tonsillar Retractor-Induced Tongue Edema Be a New Complication in Pediatric Patients Undergoing Tonsillectomy Detected by Ultrasonography? A Prospective, Case-Controlled, Observational Study. Ear Nose Throat J. 2022 Jan;101(1):42-47. doi: 10.1177/0145561320934918. Epub 2020 Jul 7.
PubMed 32633658Onal 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 32223688Bayram HH, Onal O, Akpinar S, Onal M, Aslanlar E, Ozturk M. Detection of tongue edema caused by endotracheal intubation tube in ICU patients by ultrasonography: a prospective, observational, clinical study. J Clin Monit Comput. 2024 Jun;38(3):721-729. doi: 10.1007/s10877-023-01123-0. Epub 2024 Jan 19.
PubMed 38240918
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Tongue Edema Caused by Intubation Tube in Intensive Care Unit Patients by Ultrasonography
- ClinicalTrials.gov ID
- NCT05249738
- Acronym / sponsor ID
- 02.10.2019-241
- Conditions
- Tongue Edema, Tongue Enlarged, Mechanical Ventilation Complication, Intubation Complication
- Keywords
- ultrasonography, endotracheal intubation tube, complication, drugs, tongue edema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 22 Feb 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.
Tongue edema (TE) is an enlargement of the tongue that can be noticed with the naked eye and protrudes from the mouth. Endotracheal intubation tube, which can exert high pressure on the tongue for a long time, may cause TE. This study was aimed to detect TE, which may develop due to long-term pressure application of the intubation tube to the tongue, in patients hospitalized in the intensive care unit (ICU) who underwent endotracheal intubation by submental ultrasonography (USG) method.
Detailed description
Tongue edema (TE) is an enlargement of the tongue that can be noticed with the naked eye and protrudes from the mouth. Endotracheal intubation tube, which can exert high pressure on the tongue for a long time, may cause TE. This study was aimed to detect TE, which may develop due to long-term pressure application of the intubation tube to the tongue, in patients hospitalized in the intensive care unit (ICU) who underwent endotracheal intubation by submental ultrasonography (USG) method.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | Diagnostic Test: Measuring tongue cross-sectional area by submental ultrasonographyPatients followed up with a mechanical ventilator for 4 days or longer were included in the study group. |
| Control Group | – | Diagnostic Test: Measuring tongue cross-sectional area by submental ultrasonographyPatients followed up with mechanical ventilation for 3 days or less were included in the control group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent endotracheal intubation in the Anesthesiology and Reanimation intensive care unit were followed up on a mechanical ventilator were included in the study after obtaining informed consent from their legal representatives.
Key inclusion criteria (1 listed)
- Patients aged between 18-65 years Patients who underwent endotracheal intubation and were admitted to the intensive care unit on the 0th day of intubation and patients who underwent endotracheal intubation during follow-up in the intensive care unit and were followed up on a mechanical ventilator -
Key exclusion criteria (2 listed)
- Patients under the age of 18 and over the age of 65 Patients who had a history of maxillofacial trauma, tongue surgery, head and neck malignancy, radiotherapy to the head and neck region, congenital anomalies of the tongue base and floor of the mouth Patients who were admitted to the intensive care unit due to allergy-anaphylaxis
- -
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 |
|---|---|---|
| Measuring tongue cross-sectional area by submental ultrasonographyThe tongue cross-sectional areas of both groups were measured with submental ultrasonography to detect tongue edema. | Diagnostic test | Control Group, Study Group |
Primary outcome
Detection of tongue edema by ultrasonography
Time frame: The patients' tongue cross-sectional areas were measured by submental ultrasonograph on the 0th day of endotracheal intubation and 4th day of follow-up on a mechanical ventilator. The difference between the two measurements was evaluated as tongue edema.
Primary outcome was tongue edema which is likely to develop due to the pressure exerted by endotracheal intubation tube on the tongue, by submental ultrasonography in patients who were followed up on mechanical ventilation for a long time.
1 secondary outcome
The effect of drugs applied in the intensive care unit on the development of tongue edema
Time frame: The patients' tongue cross-sectional areas were measured by submental ultrasonograph on the 0th day of endotracheal intubation and 4th day of follow-up on a mechanical ventilator. The difference between the two measurements was evaluated as tongue edema.
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 22 Feb 2022.
- Results publication: PubMed 32633658Onal M, Colpan B, Elsurer C, Bozkurt MK, Ozturk M, Onal O, Turan A. Can Tonsillar Retractor-Induced Tongue Edema Be a New Complication in Pediatric Patients Undergoing Tonsillectomy Detected by Ultrasonography? A Prospective, Case-Controlled, Observational Study. Ear Nose Throat J. 2022 Jan;101(1):42-47. doi: 10.1177/0145561320934918. Epub 2020 Jul 7.
- Results publication: 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.
- Derived from this study: PubMed 38240918Bayram HH, Onal O, Akpinar S, Onal M, Aslanlar E, Ozturk M. Detection of tongue edema caused by endotracheal intubation tube in ICU patients by ultrasonography: a prospective, observational, clinical study. J Clin Monit Comput. 2024 Jun;38(3):721-729. doi: 10.1007/s10877-023-01123-0. Epub 2024 Jan 19.
- Individual participant dataSharing planned: Undecided. Study protocol, statistical analysis plan and raw data can be shared individual if there is a valid reason.
Related trials for Tongue Edema
Not yet recruitingPhase 4
Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
Airway Edema, Postoperative Complications
Active, not recruitingObservational study
A Single-center, Prospective Study for Mechanism and Risk Factors of Tracheal Tube-related Tongue Injury
Tracheal Tube-related Tongue Injury
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Tongue Edema and Tongue Enlarged, run by Selcuk University 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 1 inclusion and 2 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 22 Feb 2022. 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?
Detection of tongue edema by ultrasonography (time frame: The patients' tongue cross-sectional areas were measured by submental ultrasonograph on the 0th day of endotracheal intubation and 4th day of follow-up on a mechanical ventilator. The difference between the two measurements was evaluated as tongue edema.). 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 NCT05249738, 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 22 Feb 2022.