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
NCT number | NCT04205253 |
Other study ID # | 2018/330 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 1, 2018 |
Est. completion date | April 1, 2019 |
Verified date | December 2019 |
Source | Selcuk University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Selcen Celik | Konya | Selcuklu |
Turkey | Selcuk University | Konya | Selcuklu |
Lead Sponsor | Collaborator |
---|---|
Selcuk University |
Turkey,
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) |
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