Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date December 2019
Source Selcuk University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Intervention

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.

Locations

Country Name City State
Turkey Selcen Celik Konya Selcuklu
Turkey Selcuk University Konya Selcuklu

Sponsors (1)

Lead Sponsor Collaborator
Selcuk University

Country where clinical trial is conducted

Turkey, 

Outcome

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)
See also
  Status Clinical Trial Phase
Completed NCT06003205 - Contributing Factors to Local Bioimpedance Spectroscopy N/A
Completed NCT02055872 - Furosemide and Albumin for Diuresis of Edema: A Pilot Randomized Controlled Trial Phase 3
Completed NCT01172522 - Topical Treatment of Under Eye Dark Circles and Swelling Phase 2
Completed NCT00602303 - Bioequivalency Study of Torsemide Tablets Under Fasting Conditions N/A
Completed NCT00602615 - Bioequivalency Study of Torsemide Tablets Under Fed Conditions N/A
Completed NCT00115726 - Trial Assessing the Effect of Preoperative Furosemide on Intraoperative Blood Pressure Phase 4
Completed NCT04595448 - Lymphatic Function in Patients With Secondary Tricuspid Valve Regurgitation
Recruiting NCT06014203 - Examination of Edema After Arthroscopic Shoulder Surgery
Completed NCT06010394 - Control of Edema in the Knee in Patients With Knee Osteoarthritis N/A
Recruiting NCT05310019 - Effect of Electroacupuncture in Patients Submitted Orthognathic Surgery and Mentoplasty N/A
Recruiting NCT03442166 - Effectiveness of Light-emitting Diode (LED) Photobiomodulation in the Extraction of Retained Lower Third Molars Phase 2
Completed NCT06220903 - The Effect of Complex Decongestive Therapy in Patients With Lymphedema N/A
Withdrawn NCT03603990 - Effect of Vitrectomy on the Evolution of Refractory Diabetic Macular Edema N/A
Recruiting NCT04927234 - Foot and Ankle Post-operative Oedema Management Using Geko™ N/A
Active, not recruiting NCT02876107 - Carboplatin and Paclitaxel With or Without Panitumumab in Treating Patients With Invasive Triple Negative Breast Cancer Phase 2
Recruiting NCT03704857 - Different Endodontic Treatment Techniques in Postoperative Symptoms, Apical Repair, Longevity of Rehabilitations, and Oral Health-related Quality of Life N/A
Recruiting NCT04606030 - LymphBridge: Surgical Evaluation for Breast Cancer-Associated Lymphedema (BioBridge) N/A
Completed NCT00732719 - Compression Device Safety Study on Edema Phase 2
Not yet recruiting NCT05534308 - Effect of Intraoperative Taping on the Control of Edema Resulting From Stripping N/A
Terminated NCT03296085 - Bedside Evaluation of Edema