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

Gastric Insufflation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05832554
• Other study ID #: AESH-2023-002
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: December 5, 2023

Study information

• Verified date: November 2023
• Source: Diskapi Teaching and Research Hospital
• Contact: Derya Ozkan, professor MD
• Phone: 0903127970000
• Email: derya_z[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 42
• Est. completion date: December 5, 2023
• Est. primary completion date: November 24, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 84 Years

Eligibility

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

Related Conditions & MeSH terms

• Difficult Mask Ventilation
• Gastric Insufflation

Intervention

Device:
• nasal airway
nasopharyngeal airway
• oral airway
oropharyngeal airway

Locations

Country	Name	City	State
Turkey	Ankara Etlik City Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Diskapi Teaching and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of gastric insufflation	Presence of gastric insufflation by ultrasound imaging in nasopharyngeal and orophrayngeal airway use	During 2 minutes mask ventilation
Primary	Difference in antral area sizes	Difference in antral area sizes measured by ultrasound imaging before and after ventilation	During 2 minutes mask ventilation
Secondary	Leakage volume	Leakage volume per minute in nasopharyngeal and orophrayngeal airway use	During 2 minutes mask ventilation