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NCT Number: NCT05249738

Tongue Edema Caused by Intubation Tube in Intensive Care Unit Patients

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.

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Key information

Conditions

Tongue Edema Intubation Complication Macroglossia Mechanical Ventilation Complication Mouth Diseases Stomatognathic Diseases Tongue Diseases Tongue Enlarged

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Selcuk University

Konya, Selcuklu, 42100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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Treatment and study plan

Measuring tongue cross-sectional area by submental ultrasonography

Diagnostic Test

The tongue cross-sectional areas of both groups were measured with submental ultrasonography to detect tongue edema.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

    Secondary outcome was tongue edema which is likely to develop due to the drugs applied in the intensive care unit by submental ultrasonography.

Other outcomes

  1. The effect of the inner diameter of endotracheal intubation tube 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.

    The exploratory outcome was tongue edema which is likely to develop due to the intubation tube with a large inner diameter.

Sponsors and collaborators

Lead sponsor

Selcuk University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 22, 2022
Registry last updated
Feb 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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