Tongue Edema Caused by Intubation Tube in Intensive Care Unit Patients

NCT ID: NCT05249738

Last Updated: 2022-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-15

Study Completion Date

2020-03-01

Brief Summary

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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.

Detailed Description

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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

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Tongue Edema Tongue Enlarged Mechanical Ventilation Complication Intubation Complication

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Study Group

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

Measuring tongue cross-sectional area by submental ultrasonography

Intervention Type DIAGNOSTIC_TEST

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.

Measuring tongue cross-sectional area by submental ultrasonography

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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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Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Selcuk University

OTHER

Sponsor Role lead

Responsible Party

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Ozkan Onal

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Selcuk University

Konya, Selcuklu, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 32633658 (View on PubMed)

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.

Reference Type RESULT
PMID: 32223688 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38240918 (View on PubMed)

Other Identifiers

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02.10.2019-241

Identifier Type: -

Identifier Source: org_study_id

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