An observational study in Side Effect, Ischemia Reperfusion Injury and Edema, sponsored by Selcuk University. Completed at 2 sites in Turkey (Türkiye). Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-12-19.
Sponsored by Selcuk University · 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.
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.
278 studies on the registry are indexed under Reperfusion Injury; 41 are open to participants now.
This study's enrollment of 64 is below the median of 100 across 46 observational studies indexed under Reperfusion Injury.
Browse Reperfusion Injury studies →Selcuk University is the lead sponsor of 255 studies on the registry; 66 are open to participants now.
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Patients aged 20 years or older who will undergo suspension laryngoscopy procedures or who did not need suspension larygoscopy procedures.
Study group
Inclusion Criteria:
Exclusion Criteria:
Control group
Inclusion Criteria:
Patients aged 20 years or older Patients who did not need suspension laryngoscopy and any head and neck procedures
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
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.
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.
Time frame: 2018-2019 (6 months)
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.
Time frame: 2018 (6 months)
Plan to share: No — Individual participant data has been planned to share after publishing as a article in a journal.
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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