Tongue Depressor-related Ischemia-Reperfusion Injury in Tongue

Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04205253
• Other study ID #: 2018/330
• Status: Completed
• Start date: October 1, 2018
• Est. completion date: April 1, 2019

Study information

• Verified date: December 2019
• Source: Selcuk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: April 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Study group

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

Related Conditions & MeSH terms

• Edema
• Ischemia
• Ischemia Reperfusion Injury
• Reperfusion Injury
• Side Effect
• Tongue Enlarged
• Wounds and Injuries

Intervention

Diagnostic Test:
• Ultrasonography imaging
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.

Locations

Country	Name	City	State
Turkey	Selcen Celik	Konya	Selcuklu
Turkey	Selcuk University	Konya	Selcuklu

Sponsors (1)

Lead Sponsor	Collaborator
Selcuk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rate of formation in tongue edema.	This study aimed to measure the formation of tongue edema due to the rigid direct laryngoscope by using ultrasonography imaging.	2018 (6 months)