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

NCT05832554 | Completed

• 1 other identifier: AESH-2023-002
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Insufflation; Difficult Mask Ventilation

Keywords

Nasopharyngeal airway; Oropharyngeal airway; Difficult airway

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Leakage volume

  During 2 minutes mask ventilation

Study Arms (2)

Nasopharyngeal airway

ACTIVE COMPARATOR

Patients with nasopharygeal airway placed

Device: nasal airway

Orophryngeal airway

ACTIVE COMPARATOR

Patients with oropharygeal airway placed

Device: oral airway

Interventions

nasal airway DEVICE

nasopharyngeal airway

Nasopharyngeal airway

oral airway DEVICE

oropharyngeal airway

Orophryngeal airway

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients receiving general anesthesia
• ASA score I-II-III
• At least 3 criteria out of 5 difficult mask criteria defined by Langeron et al.

You may not qualify if:

• Patients who did not give informed consent
• Risk of aspiration
• Respiratory disease
• Facial, oropharyngeal or nasopharyngeal pathology
• Pregnancy

Sponsors & Collaborators

• Diskapi Teaching and Research Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital

Ankara, 06710, Turkey (Türkiye)

Location

Related 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.

  PMID: 24317204 BACKGROUND

• 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.

  PMID: 10781266 BACKGROUND

MeSH Terms

Interventions

Continuous Positive Airway Pressure

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Derya Ozkan, proff MD

  Ankara Etlik City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor MD

Study Record Dates

• First Submitted: April 15, 2023
• First Posted: April 27, 2023
• Study Start: May 1, 2023
• Primary Completion: November 24, 2023
• Study Completion: January 5, 2024
• Last Updated: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)