Tongue Edema Caused by Intubation Tube in Intensive Care Unit Patients

Sponsor

Selcuk University (Other)

Overall Status

Completed

CT.gov ID

NCT05249738

Collaborator

(none)

100

Enrollment

Location

4.5

Actual Duration (Months)

22.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Tongue Edema Tongue Enlarged Mechanical Ventilation Complication Intubation Complication	Diagnostic Test: Measuring tongue cross-sectional area by submental ultrasonography

Detailed Description

Study Design

Study Type:

Observational

Actual Enrollment :

100 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Oct 15, 2019

Actual Primary Completion Date :

Mar 1, 2020

Actual Study Completion Date :

Mar 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Study Group Patients followed up with a mechanical ventilator for 4 days or longer were included in the study group.	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.
Control Group Patients followed up with mechanical ventilation for 3 days or less were included in the control group.	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.

Arm

Intervention/Treatment

Study Group

Patients followed up with a mechanical ventilator for 4 days or longer were included in the study group.

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.

Control Group

Patients followed up with mechanical ventilation for 3 days or less were included in the control group.

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.

Outcome Measures

Primary Outcome Measures

Detection of tongue edema by 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.]
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.

Secondary Outcome Measures

The effect of drugs applied in the intensive care unit on the development of tongue edema [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 outcome was tongue edema which is likely to develop due to the drugs applied in the intensive care unit by submental ultrasonography.

Other Outcome Measures

The effect of the inner diameter of endotracheal intubation tube on the development of tongue edema. [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.]
The exploratory outcome was tongue edema which is likely to develop due to the intubation tube with a large inner diameter.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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