Tongue Edema Caused by Intubation Tube in Intensive Care Unit Patients

NCT05249738 | Completed

• 1 other identifier: 02.10.2019-241
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Tongue Edema; Tongue Enlarged; Mechanical Ventilation Complication; Intubation Complication

Keywords

ultrasonography; endotracheal intubation tube; complication; drugs; tongue edema

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Other Outcomes (1)

• 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.

Study Arms (2)

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

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

Interventions

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.

Control Group; Study Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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 -

You may not qualify if:

• 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

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (1)

Selcuk University

Konya, Selcuklu, 42100, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 32633658 RESULT

• 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. Acta Otolaryngol. 2020 Jul;140(7):583-588. doi: 10.1080/00016489.2020.1743353. Epub 2020 Mar 30.

  PMID: 32223688 RESULT

• Bayram 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.

  PMID: 38240918 DERIVED

MeSH Terms

Conditions

Macroglossia

Condition Hierarchy (Ancestors)

Tongue Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 11, 2022
• First Posted: February 22, 2022
• Study Start: October 15, 2019
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: February 22, 2022

Record last verified: 2022-02

Locations

TU (1)