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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05832554

Enrollment

Registered

2023-04-27

Start date

2023-05-01

Completion date

2024-01-05

Last updated

2024-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Difficult Mask Ventilation, Gastric Insufflation

Keywords

Nasopharyngeal airway, Oropharyngeal airway, Difficult airway

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.

Interventions

DEVICEnasal airway

nasopharyngeal airway

DEVICEoral airway

oropharyngeal airway

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 84 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Leakage volume	During 2 minutes mask ventilation	Leakage volume per minute in nasopharyngeal and orophrayngeal airway use

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026