Tongue Depressor-related Ischemia-Reperfusion Injury in Tongue

NCT04205253 | Completed

• 1 other identifier: 2018/330
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 2

Brief Summary

This study aimed to detect tongue edema associated with the pressure exerted by a rigid direct laryngoscope by measuring the tongue area using USG in patients undergoing suspension laryngoscopy (SL) procedures.

Conditions

Side Effect; Ischemia Reperfusion Injury; Edema; Tongue Enlarged

Keywords

tongue; ischemia-reperfusion injury; side effect; edema; suspension laryngoscopy

Outcome Measures

Primary Outcomes (1)

• Rate of change in tongue area.

  This study aimed to measure the change in tongue areas before and after the implementation of rigid direct laryngoscope by using ultrasonography imaging.

  2018-2019 (6 months)

Secondary Outcomes (1)

• Rate of formation in tongue edema.

  2018 (6 months)

Study Arms (2)

Study

The first group is the study group. Patients aged 20 years or older and were to undergo suspension laryngoscopy procedure were eligible for inclusion in this group. Tongue areas were measured twice by submental USG. The first measurements (TA1) were done immediately after endotracheal intubation before introducing the rigid direct laryngoscope, whereas the second measurements (TA2) were done after the SL procedure and after removing the rigid direct laryngoscope just before extubation.The difference between TA2 and TA1 (i.e., TA2-TA1) were used to define the occurrence of tongue edema as study group.

Diagnostic Test: Ultrasonography imaging

Control

The second group was the control group, which included patients who did not need SL and any head and neck procedures.The tongue areas of these patients were measured twice by submental USG as in the study group. The TA1 measurements were done immediately after endotracheal intubation, whereas the TA2 measurements were done at the end of the surgical procedure just before extubation. The difference between TA2 and TA1 (i.e., TA2-TA1) were used to define the occurrence of tongue edema as study group.

Diagnostic Test: Ultrasonography imaging

Interventions

Ultrasonography imaging DIAGNOSTIC_TEST

This study aimed to evaluate the tongue areas and compare the tongue areas before the implementation of rigid direct laryngoscope and after the rigid direct laryngoscope.

Control; Study

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 20 years or older who will undergo suspension laryngoscopy procedures or who did not need suspension larygoscopy procedures.

You may qualify if:

• Patients aged 20 years or older
• Patients who undergo suspension laryngoscope procedure

You may not qualify if:

• refusal to participate
• age of \<20 years
• history of syndromal craniofacial abnormalities
• occurrence of tongue masses
• history of craniofacial surgery
• history of burns, trauma or radiotherapy involving the head and neck region
• neurologic disorders and patients with obstructive sleep apnea syndrome (OSAS)
• active inflammation in the head and neck region
• cervical rigidity limiting neck flexion and head extension
• Control group
• Patients aged 20 years or older Patients who did not need suspension laryngoscopy and any head and neck procedures

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (2)

Selcen Celik

Konya, Selcuklu, 42100, Turkey (Türkiye)

Location

Selcuk University

Konya, Selcuklu, 42100, Turkey (Türkiye)

Location

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Reperfusion Injury; Edema; Macroglossia

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Tongue Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Ozkan Onal, Professor

  Selcuk University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: December 19, 2019
• Study Start: October 1, 2018
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: December 19, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)