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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2024-01-05

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.

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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.

Conditions

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Gastric Insufflation Difficult Mask Ventilation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Nasopharyngeal airway

Patients with nasopharygeal airway placed

Group Type ACTIVE_COMPARATOR

nasal airway

Intervention Type DEVICE

nasopharyngeal airway

Orophryngeal airway

Patients with oropharygeal airway placed

Group Type ACTIVE_COMPARATOR

oral airway

Intervention Type DEVICE

oropharyngeal airway

Interventions

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nasal airway

nasopharyngeal airway

Intervention Type DEVICE

oral airway

oropharyngeal airway

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

84 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No