Gastric InsufflationNCT05832554
Comparison of the Effects of Nasal and Oral Airway Use on Gastric Insufflation
A study testing nasal airway and oral airway in people with Gastric Insufflation and Difficult Mask Ventilation, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Gastric Insufflation, Difficult Mask Ventilation
- What is being tested?
- nasal airway and oral airway
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2023to 5 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients receiving general anesthesia
- ASA score I-II-III
- At least 3 criteria out of 5 difficult mask criteria defined by Langeron et al.
Who cannot join
- Patients who did not give informed consent
- Risk of aspiration
- Respiratory disease
- Facial, oropharyngeal or nasopharyngeal pathology
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Gastric Insufflation, Difficult Mask Ventilation
- Being tested
- nasal airway, oral airway
- Keywords
- Nasopharyngeal airway, Oropharyngeal airway, Difficult airway
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasal airwayDevice
nasopharyngeal airway
oral airwayDevice
oropharyngeal airway
| Study group | Role | What they receive |
|---|---|---|
| Nasopharyngeal airway | Active comparator | Patients with nasopharygeal airway placed Receives: Device: nasal airway |
| Orophryngeal airway | Active comparator | Patients with oropharygeal airway placed Receives: Device: oral airway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of gastric insufflation
Presence of gastric insufflation by ultrasound imaging in nasopharyngeal and orophrayngeal airway use
Measured: During 2 minutes mask ventilation
Difference in antral area sizes
Difference in antral area sizes measured by ultrasound imaging before and after ventilation
Measured: During 2 minutes mask ventilation
Secondary outcomes (1)
Leakage volume
Leakage volume per minute in nasopharyngeal and orophrayngeal airway use
Measured: During 2 minutes mask ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start1 May 2023
- Primary completion24 Nov 2023
- Study completion5 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastric InsufflationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, derya özkan, Diskapi Teaching and Research Hospital
- Investigators
- Derya Ozkan, proff MD, Principal investigator, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05832554
- Sponsor's protocol ID
- AESH-2023-002
- Status last verified
- Jul 2024
- First submitted
- 15 Apr 2023
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 24317204Langeron 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05832554
- Acronym / sponsor ID
- AESH-2023-002
- Conditions
- Gastric Insufflation, Difficult Mask Ventilation
- Keywords
- Nasopharyngeal airway, Oropharyngeal airway, Difficult airway
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 24 Nov 2023 (actual)
- Study completion
- 5 Jan 2024 (actual)
- First posted
- 27 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasopharyngeal airway | Active comparator | Device: nasal airwayPatients with nasopharygeal airway placed |
| Orophryngeal airway | Active comparator | Device: oral airwayPatients with oropharygeal airway placed |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients receiving general anesthesia
- ASA score I-II-III
- At least 3 criteria out of 5 difficult mask criteria defined by Langeron et al.
Key exclusion criteria (5 listed)
- Patients who did not give informed consent
- Risk of aspiration
- Respiratory disease
- Facial, oropharyngeal or nasopharyngeal pathology
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nasal airwaynasopharyngeal airway | Device | Nasopharyngeal airway |
| oral airwayoropharyngeal airway | Device | Orophryngeal airway |
Primary outcome
Presence of gastric insufflation
Time frame: During 2 minutes mask ventilation
Presence of gastric insufflation by ultrasound imaging in nasopharyngeal and orophrayngeal airway use
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
1 secondary outcome
Leakage volume
Time frame: During 2 minutes mask ventilation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Background: PubMed 24317204Bouvet 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.
- Background: PubMed 10781266Langeron 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Derya Ozkan, proff MD principal investigator
Ankara Etlik City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nasal airway and oral airway in people with Gastric Insufflation and Difficult Mask Ventilation, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of gastric insufflation (time frame: During 2 minutes mask ventilation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05832554, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.