CompletedNCT05832554Updated Jul 25, 2024

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

An interventional study of nasal airway and oral airway in Gastric Insufflation and Difficult Mask Ventilation, sponsored by Diskapi Teaching and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 84 Years. Per ClinicalTrials.gov, last updated 2024-07-25.

Sponsored by Diskapi Teaching and Research Hospital · Not applicable, Interventional, and Prevention

Phase: Not applicable
Study type: Interventional
Enrollment: 58
Allocation: Randomized
Ages: 18 Years to 84 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Gastric Insufflation
Difficult Mask Ventilation

Keywords

Nasopharyngeal airway
Oropharyngeal airway
Difficult airway

In context

Lead sponsor

Diskapi Teaching and Research Hospital is the lead sponsor of 101 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 84 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

Exclusion Criteria:

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

Study design

Phase: Not applicable
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Outcomes assessor)
Enrollment: 58 participants (actual)

Study arms

Active comparator
Nasopharyngeal airway
Patients with nasopharygeal airway placed
Device: nasal airway
Active comparator
Orophryngeal airway
Patients with oropharygeal airway placed
Device: oral airway

Interventions

Devicenasal airway
nasopharyngeal airway
Deviceoral airway
oropharyngeal airway

What researchers measure

Primary outcomes

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

Secondary outcomes

Leakage volume
Leakage volume per minute in nasopharyngeal and orophrayngeal airway use
Time frame: During 2 minutes mask ventilation

Study locations

1 site

Ankara Etlik City Hospital
Ankara, 06710, Turkey

References and documents

Publications

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. PubMed 24317204 ↗
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. PubMed 10781266 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05832554
Lead sponsor: Diskapi Teaching and Research Hospital
Responsible party: derya özkan (Professor MD, Diskapi Teaching and Research Hospital) — Principal investigator
First posted: Apr 27, 2023
Start date: May 1, 2023
Primary completion: Nov 24, 2023
Completion: Jan 5, 2024
Last update: Jul 25, 2024

Study contacts

Derya Ozkan, proff MD

principal investigator · Ankara Etlik City Hospital

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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