Comparison Of The Effect Of Supine And Prone Position On The Ultrasonographic Airway Measurements

A Prospective Randomized Comparison Of The Effect Of Supine And Prone Position On The Ultrasonographic Upper Airway Measurements And Postoperative Critical Respiratory Events

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obstructive Sleep Apnea; Respiratory Complication; Airway Edema
• Intervention / Treatment: Diagnostic test: preoperative airway ultrasonography; Diagnostic test: postoperative airway ultrasonography

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Betül Güven Aytaç, MD; Phone Number: +905073578351; Email: drbguven@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: supine; operation in the supine position	Diagnostic test: preoperative airway ultrasonography; Tongue thickness Median sagittal tongue cross-sectional area Tongue width Tongue volume: Lateral parapharyngeal wall thickness; Diagnostic test: postoperative airway ultrasonography; Tongue thickness Median sagittal tongue cross-sectional area Tongue width Tongue volume: Lateral parapharyngeal wall thickness
Active Comparator: prone; operation in the prone position	Diagnostic test: preoperative airway ultrasonography; Tongue thickness Median sagittal tongue cross-sectional area Tongue width Tongue volume: Lateral parapharyngeal wall thickness; Diagnostic test: postoperative airway ultrasonography; Tongue thickness Median sagittal tongue cross-sectional area Tongue width Tongue volume: Lateral parapharyngeal wall thickness

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Preoperative Tongue thickness	Baseline, preoperative
postoperative Tongue thickness1	postextubation
postoperative Tongue thickness2	postoperative 2. hour]
preoperative Tongue volume	Baseline, preoperative
postoperative Tongue volume1	postextubation
postoperative Tongue volume2	postoperative 2. hour
Preoperative Lateral parapharyngeal wall thickness	Baseline, preoperative
postoperative Lateral parapharyngeal wall thickness1	postextubation
postoperative Lateral parapharyngeal wall thickness2	postoperative 2. hour
Critical respiratory events	Within postoperative 2 hours

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent
• Investigators: Study Chair: betül güven aytaç, Ankara CH Bilkent; Principal Investigator: ışıl karabeyoğlu, md, Ankara CH Bilkent

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2022
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): July 1, 2022

Study Registration Dates

• First Submitted: January 5, 2022
• First Submitted That Met QC Criteria: January 5, 2022
• First Posted (Actual): January 19, 2022

Study Record Updates

• Last Update Posted (Actual): January 19, 2022
• Last Update Submitted That Met QC Criteria: January 5, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: obstructive sleep apnea; respiratory complications; airway edema
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: E1-21-2261

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No