Tongue Depressor-related Ischemia-Reperfusion Injury in Tongue

Completed

• Conditions: Edema; Tongue Enlarged; Side Effect; Ischemia Reperfusion Injury
• Interventions: Diagnostic Test: Ultrasonography imaging

• Registration Number: NCT04205253
• Lead Sponsor: Selcuk University

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.

Detailed Description

Suspension laryngoscopy (SL) is a surgical procedure for both diagnostic and therapeutic purposes. In this procedure, a rigid direct laryngoscope is inserted orally, and the tongue and the base of the tongue are compressed.The tongue is an ideal organ for evaluation with ultrasonography. This study aimed to detect the occurrence of tongue edema through ultrasonography examination due to the rigid direct laryngoscope in SL procedures.

Study Timeline

• Study Start: 2018-10-01
• Primary Completion: 2019-04-01
• Study Completion: 2019-04-01
• Status Verified: 2019-12
• Study First Submitted: 2019-12-17
• Study First Submitted QC: 2019-12-18
• Last Update Submitted: 2019-12-18
• Study First Posted: 2019-12-19
• Last Update Posted: 2019-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

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

Exclusion Criteria

• 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

Inclusion Criteria:

Patients aged 20 years or older Patients who did not need suspension laryngoscopy and any head and neck procedures

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study	Ultrasonography imaging	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.
Control	Ultrasonography imaging	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.

Primary Outcome Measures

Name	Time	Method
Rate of change in tongue area.	2018-2019 (6 months)	This study aimed to measure the change in tongue areas before and after the implementation of rigid direct laryngoscope by using ultrasonography imaging.

Secondary Outcome Measures

Name	Time	Method
Rate of formation in tongue edema.	2018 (6 months)	This study aimed to measure the formation of tongue edema due to the rigid direct laryngoscope by using ultrasonography imaging.

Trial Locations

Locations (2)

Selcen Celik; 🇹🇷 Konya, Selcuklu, Turkey

Selcuk University; 🇹🇷 Konya, Selcuklu, Turkey