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NCT Number: NCT05832554

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

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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Key information

Conditions

Gastric Insufflation Difficult Mask Ventilation

Age range

18 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Etlik City Hospital

Ankara, 06710, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nasal airway

Device

nasopharyngeal airway

oral airway

Device

oropharyngeal airway

Primary outcomes

  1. Presence of gastric insufflation

    Time frame: During 2 minutes mask ventilation

    Presence of gastric insufflation by ultrasound imaging in nasopharyngeal and orophrayngeal airway use

  2. Difference in antral area sizes

    Time frame: During 2 minutes mask ventilation

    Difference in antral area sizes measured by ultrasound imaging before and after ventilation

Secondary outcomes

  1. Leakage volume

    Time frame: During 2 minutes mask ventilation

    Leakage volume per minute in nasopharyngeal and orophrayngeal airway use

Sponsors and collaborators

Lead sponsor

Diskapi Teaching and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Apr 27, 2023
Registry last updated
Jul 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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