Clinical trial NCT04205253: Tongue Depressor-related Ischemia-Reperfusion Injury in Tongue
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Side Effect
Ischemia Reperfusion Injury
Edema
Tongue Enlarged
Keywords: tongue
ischemia-reperfusion injury
side effect
edema
suspension laryngoscopy
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2019-12-19
Enrollment: 64
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate of change in tongue area.
timeFrame: 2018-2019 (6 months)
Secondary outcomes:
measure: Rate of formation in tongue edema.
timeFrame: 2018 (6 months)
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcen Celik
state: Selcuklu
city: Konya
country: Turkey
facility: Selcuk University
state: Selcuklu
Study officials:
affiliation: Selcuk University
name: Ozkan Onal, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.