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Completed

NCT Number: NCT04205253

Tongue Depressor-related Ischemia-Reperfusion Injury in Tongue

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.

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Key information

Conditions

Side Effect Cardiovascular Diseases Edema Ischemia Reperfusion Injury Macroglossia Mouth Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Reperfusion Injury Signs and Symptoms Stomatognathic Diseases Tongue Diseases Tongue Enlarged Vascular Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Selcen Celik, Konya, Selcuklu, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Rate of change in tongue area.

    Time frame: 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 outcomes

  1. Rate of formation in tongue edema.

    Time frame: 2018 (6 months)

    This study aimed to measure the formation of tongue edema due to the rigid direct laryngoscope by using ultrasonography imaging.

Sponsors and collaborators

Lead sponsor

Selcuk University

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 19, 2019
Registry last updated
Dec 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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