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

Not Applicable

Completed

• Conditions: Gastric Insufflation; Difficult Mask Ventilation
• Interventions: Device: nasal airway; Device: oral airway

• Registration Number: NCT05832554
• Lead Sponsor: Diskapi Teaching and Research Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2023-04-15
• Study First Submitted QC: 2023-04-15
• Study First Posted: 2023-04-27
• Study Start: 2023-05-01
• Primary Completion: 2023-11-24
• Study Completion: 2024-01-05
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-24
• Last Update Posted: 2024-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nasopharyngeal airway	nasal airway	Patients with nasopharygeal airway placed
Orophryngeal airway	oral airway	Patients with oropharygeal airway placed

Primary Outcome Measures

Name	Time	Method
Difference in antral area sizes	During 2 minutes mask ventilation	Difference in antral area sizes measured by ultrasound imaging before and after ventilation
Presence of gastric insufflation	During 2 minutes mask ventilation	Presence of gastric insufflation by ultrasound imaging in nasopharyngeal and orophrayngeal airway use

Secondary Outcome Measures

Name	Time	Method
Leakage volume	During 2 minutes mask ventilation	Leakage volume per minute in nasopharyngeal and orophrayngeal airway use

Trial Locations

Locations (1)

Ankara Etlik City Hospital; 🇹🇷 Ankara, Turkey