Tongue Edema Caused by Intubation Tube in Intensive Care Unit Patients

February 11, 2022 updated by: Ozkan Onal, Selcuk University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Selcuklu
      • Konya, Selcuklu, Turkey, 42100
        • Selcuk University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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 Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Selcuk University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 11, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 22, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 22, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 02.10.2019-241

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Study protocol, statistical analysis plan and raw data can be shared individual if there is a valid reason.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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