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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05197400
Other study ID # E1-21-2261
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 2022
Est. completion date July 2022

Study information

Verified date January 2022
Source Ankara City Hospital Bilkent
Contact betül güven aytaç, md
Phone +905073578351
Email drbguven@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to compare the preoperative and postoperative ultrasonographic measurements of patients undergoing in the prone position and the change in upper airway edema. The secondary aim of the study is to investigate the relationship between OSAS risk levels determined by the STOP-BANG score in the preoperative period of the patients participating in the study, and airway ultrasound measurements and postoperative critical respiratory events in the preoperative and postoperative period.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date July 2022
Est. primary completion date May 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:1-American Society of Anesthesiologists Physical Status Classification (ASA) I-II-III-IV risk group who will undergo Percutaneous Nephrolithotomy surgery Exclusion Criteria: 1. prone position contraindications 2. history of maxillofacial deformity, tumor or trauma, 3. difficult airway history 4. decompensated cardiac, respiratory, hepatic, renal diseases 5. cervical spine fracture 6. Patients refusal -

Study Design


Intervention

Diagnostic Test:
preoperative airway ultrasonography
Tongue thickness Median sagittal tongue cross-sectional area Tongue width Tongue volume: Lateral parapharyngeal wall thickness
postoperative airway ultrasonography
Tongue thickness Median sagittal tongue cross-sectional area Tongue width Tongue volume: Lateral parapharyngeal wall thickness

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ankara City Hospital Bilkent

Outcome

Type Measure Description Time frame Safety issue
Primary Preoperative Tongue thickness Baseline, preoperative
Primary postoperative Tongue thickness1 postextubation
Primary postoperative Tongue thickness2 postoperative 2. hour]
Primary preoperative Tongue volume Baseline, preoperative
Primary postoperative Tongue volume1 postextubation
Primary postoperative Tongue volume2 postoperative 2. hour
Primary Preoperative Lateral parapharyngeal wall thickness Baseline, preoperative
Primary postoperative Lateral parapharyngeal wall thickness1 postextubation
Primary postoperative Lateral parapharyngeal wall thickness2 postoperative 2. hour
Primary Critical respiratory events Within postoperative 2 hours
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