Comparison of the Effects of Nasal and Oral Airway Use on Gastric Insufflation

Study Overview
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Brief Summary
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The goal of this clinical trial is to compare the effects of nasopharyngeal and oropharyngeal airway on gastric insufflation in patients undergoing general anesthesia and expected difficult mask ventilation. The main questions it aims to answer are: Is there a difference between the presence of gastric insufflation in the use of nasopharyngeal and oropharyngeal airways? Is there a difference between the antral area sizes measured before and after ventilation After general anesthesia induction, nasopharyngeal or oropharyngeal airway will be placed in participants and real-time ultrasonographic gastric antral area imaging will be performed during mask ventilation. Researchers will compare the effects of nasopharyngeal and oropharyngeal airway use on gastric insufflation.

Detailed Description
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Patients who are expected to have difficult mask ventilation and receive general anesthesia will be included in the study. After preoperative gastric antral area measurements of the patients by ultrasonography, preoxygenation will be applied and anesthesia induction will be performed. Real-time gastric ultrasonography will be performed during pressure-controlled mask ventilation for 2 minutes after nasopharyngeal or oropharyngeal airway insertion, and then antral area measurement will be repeated. After the trachea was intubated, the antral area measurement was once again performed. At the 30th, 60th, 90th and 120th seconds of ventilation, patients' SpO2, EtO2, EtCO2, peak airway pressure, tidal volume, leak volumes and hemodynamic changes will be recorded.

Official Title
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Comparison of the Effects of Nasopharyngeal and Oropharyngeal Airway Use on Gastric Insufflation in Patients Who Are Expected to Have Difficult Mask Ventilation

Conditions
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Gastric Insufflation, Difficult Mask Ventilation

Intervention / Treatment
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* Device: nasal airway
* Device: oral airway


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients receiving general anesthesia ASA score I-II-III At least 3 criteria out of 5 difficult mask criteria defined by Langeron et al. Exclusion Criteria: Patients who did not give informed consent Risk of aspiration Respiratory disease Facial, oropharyngeal or nasopharyngeal pathology Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 84 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nasopharyngeal airway<br>Patients with nasopharygeal airway placed | Device: nasal airway<br>* nasopharyngeal airway<br>|
| Active Comparator: Orophryngeal airway<br>Patients with oropharygeal airway placed | Device: oral airway<br>* oropharyngeal airway<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of gastric insufflation | Presence of gastric insufflation by ultrasound imaging in nasopharyngeal and orophrayngeal airway use | During 2 minutes mask ventilation | 
| Difference in antral area sizes | Difference in antral area sizes measured by ultrasound imaging before and after ventilation | During 2 minutes mask ventilation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leakage volume | Leakage volume per minute in nasopharyngeal and orophrayngeal airway use | During 2 minutes mask ventilation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nasopharyngeal airway, Oropharyngeal airway, Difficult airway