Tongue Edema Caused by Intubation Tube in Intensive Care Unit Patients

Mechanical Ventilation Complication Clinical Trial

Official title:

Detection of Tongue Edema Caused by Intubation Tube in Intensive Care Unit Patients by Ultrasonography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05249738
• Other study ID #: 02.10.2019-241
• Status: Completed
• 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
• 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 -

Related Conditions & MeSH terms

• Edema
• Intubation Complication
• Mechanical Ventilation Complication
• Tongue Diseases
• Tongue Enlarged

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.