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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05249738
Other study ID # 02.10.2019-241
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 15, 2019
Est. completion date March 1, 2020

Study information

Verified date February 2022
Source Selcuk University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date March 1, 2020
Est. primary completion date March 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: 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 - Exclusion Criteria: 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 -

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Measuring tongue cross-sectional area by submental ultrasonography
The tongue cross-sectional areas of both groups were measured with submental ultrasonography to detect tongue edema.

Locations

Country Name City State
Turkey Selcuk University Konya Selcuklu

Sponsors (1)

Lead Sponsor Collaborator
Selcuk University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

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, Observationa — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other The effect of the inner diameter of endotracheal intubation tube on the development of tongue edema. The exploratory outcome was tongue edema which is likely to develop due to the intubation tube with a large inner diameter. 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 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. 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 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. 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.
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