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Clinical Trials/NCT05832554
NCT05832554
Completed
Not Applicable

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

Diskapi Teaching and Research Hospital1 site in 1 country58 target enrollmentMay 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gastric Insufflation
Sponsor
Diskapi Teaching and Research Hospital
Enrollment
58
Locations
1
Primary Endpoint
Difference in antral area sizes
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2023
End Date
January 5, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

derya özkan

Professor MD

Diskapi Teaching and Research Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Presence of gastric insufflation

Time Frame: During 2 minutes mask ventilation

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

Secondary Outcomes

  • Leakage volume(During 2 minutes mask ventilation)

Study Sites (1)

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