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

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.

Study Overview

• Status: Completed
• Conditions: Gastric Insufflation; Difficult Mask Ventilation
• Intervention / Treatment: Device: nasal airway; Device: oral airway

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 Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06710
    • Ankara Etlik City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Nasopharyngeal airway; Patients with nasopharygeal airway placed	Device: nasal airway; nasopharyngeal airway
Active Comparator: Orophryngeal airway; Patients with oropharygeal airway placed	Device: oral airway; oropharyngeal airway

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Diskapi Teaching and Research Hospital
• Investigators: Principal Investigator: Derya Ozkan, proff MD, Ankara Etlik City Hospital

Publications and helpful links

General Publications

• Langeron O, Masso E, Huraux C, Guggiari M, Bianchi A, Coriat P, Riou B. Prediction of difficult mask ventilation. Anesthesiology. 2000 May;92(5):1229-36. doi: 10.1097/00000542-200005000-00009.
• Bouvet L, Albert ML, Augris C, Boselli E, Ecochard R, Rabilloud M, Chassard D, Allaouchiche B. Real-time detection of gastric insufflation related to facemask pressure-controlled ventilation using ultrasonography of the antrum and epigastric auscultation in nonparalyzed patients: a prospective, randomized, double-blind study. Anesthesiology. 2014 Feb;120(2):326-34. doi: 10.1097/ALN.0000000000000094.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Actual): November 24, 2023
• Study Completion (Actual): January 5, 2024

Study Registration Dates

• First Submitted: April 15, 2023
• First Submitted That Met QC Criteria: April 15, 2023
• First Posted (Actual): April 27, 2023

Study Record Updates

• Last Update Posted (Actual): July 25, 2024
• Last Update Submitted That Met QC Criteria: July 24, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Difficult airway; Nasopharyngeal airway; Oropharyngeal airway
• Other Study ID Numbers: AESH-2023-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No