Tongue Depressor-related Ischemia-Reperfusion Injury in Tongue

• Sponsor: Selcuk University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04205253
• Collaborator: (none)
• Enrollment: 64
• Locations: 2
• Actual Duration (Months): 6
• Patients Per Site: 32
• Patients Per Site Per Month: 5.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Side Effect; Ischemia Reperfusion Injury; Edema; Tongue Enlarged	Diagnostic Test: Ultrasonography imaging

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 Design

• Study Type: Observational
• Actual Enrollment: 64 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Oct 1, 2018
• Actual Primary Completion Date: Apr 1, 2019
• Actual Study Completion Date: Apr 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
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; 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 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; 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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Selcen Celik	Konya	Selcuklu	Turkey	42100
2	Selcuk University	Konya	Selcuklu	Turkey	42100

Sponsors and Collaborators

• Selcuk University

Investigators

• Principal Investigator: Ozkan Onal, Professor, Selcuk University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ozkan Onal, Professor, Selcuk University
• ClinicalTrials.gov Identifier: NCT04205253
• Other Study ID Numbers: 2018/330
• First Posted: Dec 19, 2019
• Last Update Posted: Dec 19, 2019
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ozkan Onal, Professor, Selcuk University: tongue; ischemia-reperfusion injury; side effect; edema; suspension laryngoscopy
• Additional relevant MeSH terms: Reperfusion Injury; Ischemia; Wounds and Injuries

Study Results

No Results Posted as of Dec 19, 2019