Positive-Pressure RespirationUGVNCT02906267
Ultrasonographic Comparison of Gastric Volume After Three Modes of Positive Facemask During Induction of Anaesthesia
A study testing Diagnostic ultrasonography of gastric volume in people with Positive-Pressure Respiration and Respiratory Aspiration of Gastric Content, run by University Hospital, Brest at 1 site in France.
Trial summary
This study is designed to evaluate the occurrence of gastric insufflation and the critical volume of the stomach after three different modes of positive pressure ventilation during induction (Manual-controlled, volume-controlled and pressure-controlled ventilation) Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Positive-Pressure Respiration, Respiratory Aspiration of Gastric Content
- What is being tested?
- Diagnostic ultrasonography of gastric volume
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2016to Dec 2017
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA status I and II
Who cannot join
- Pregnant woman Obese patient (BMI>30kgm-2) oropharyngeal or facial anomalies anticipated difficult mask ventilation upper respiratory tract infection history of gastric surgery patient refusal
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHRU de Brest
Brest
Pierre LAFERE, MD, PhD, pierre.lafere@chu-brest.fr
About this study
Official title: Ultrasonographic Comparison of Gastric Volume After Three Modes of Positive Facemask. A Prospective Randomized Study.
This study is designed to evaluate the occurrence of gastric insufflation and the critical volume of the stomach after three different modes of positive pressure ventilation during induction (Manual-controlled, volume-controlled and pressure-controlled ventilation)
Read the detailed description
Aspiration of gastric contents can be a serious perioperative complication, which can be related to facemask positive pressure ventilation with unprotected airway. Even with low peak airway pressure (<15 cm H2O) gastric insufflation may occur. Since gastric content and volume assessment is a new point-of-care ultrasound recommended application, the cross-sectional antra area will be measured using ultrasonography before, continuously during facemask ventilation and after intubation.
- Being tested
- Diagnostic ultrasonography of gastric volume
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic ultrasonography of gastric volumeOther
Ultrasonic measurement of gastric insufflation during positive pressure ventilation (secondary endpoint) and final gastric volume after positive pressure ventilation (primary endpoint)
| Study group | Role | What they receive |
|---|---|---|
| Manual-controlled | Other | Patient in the manual ventilation group will receive facemask ventilation to get a tidal volume of 8-10ml/kg with a respiratory rate of 15/min. The pop-off valve will be set to 20 cm H2O. Receives: Other: Diagnostic ultrasonography of gastric volume |
| Volume-controlled | Other | mechanical breath will be delivered by a Primus ventilator (Dräger, Lubeck, Germany) at a frequency of 15 breath/min. Tidal volume will be set to 8-10 ml/min. Receives: Other: Diagnostic ultrasonography of gastric volume |
| Pressure-controlled | Other | mechanical breath will be delivered by a Primus ventilator (Dräger, Lubeck, Germany) at a frequency of 15 breath/min. Pressure will be adjusted to obtain a tidal volume of 8-10 ml/min. Receives: Other: Diagnostic ultrasonography of gastric volume |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric volume before and after positive pressure ventilation
Measured: 15 minutes
Secondary outcomes (1)
Ultrasonographic detection of gastric insufflation during ventilation
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Positive-Pressure RespirationStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 123 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LAFERE Pierre, University Hospital, Brest
- Investigators
- Pierre LAFERE, MD,PhD, Principal investigator, CHRU de Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02906267
- Sponsor's protocol ID
- Ultrasonic gastric volume
- Acronym
- UGV
- Status last verified
- Jul 2017
- First submitted
- 5 Sep 2016
- Last updated
- 17 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic Comparison of Gastric Volume After Three Modes of Positive Facemask. A Prospective Randomized Study.
- ClinicalTrials.gov ID
- NCT02906267
- Acronym / sponsor ID
- UGV / Ultrasonic gastric volume
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 123 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 20 Sep 2016 (estimated)
- 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.
This study is designed to evaluate the occurrence of gastric insufflation and the critical volume of the stomach after three different modes of positive pressure ventilation during induction (Manual-controlled, volume-controlled and pressure-controlled ventilation)
Detailed description
Aspiration of gastric contents can be a serious perioperative complication, which can be related to facemask positive pressure ventilation with unprotected airway. Even with low peak airway pressure (<15 cm H2O) gastric insufflation may occur. Since gastric content and volume assessment is a new point-of-care ultrasound recommended application, the cross-sectional antra area will be measured using ultrasonography before, continuously during facemask ventilation and after intubation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Manual-controlled | Other | Other: Diagnostic ultrasonography of gastric volumePatient in the manual ventilation group will receive facemask ventilation to get a tidal volume of 8-10ml/kg with a respiratory rate of 15/min. The pop-off valve will be set to 20 cm H2O. |
| Volume-controlled | Other | Other: Diagnostic ultrasonography of gastric volumemechanical breath will be delivered by a Primus ventilator (Dräger, Lubeck, Germany) at a frequency of 15 breath/min. Tidal volume will be set to 8-10 ml/min. |
| Pressure-controlled | Other | Other: Diagnostic ultrasonography of gastric volumemechanical breath will be delivered by a Primus ventilator (Dräger, Lubeck, Germany) at a frequency of 15 breath/min. Pressure will be adjusted to obtain a tidal volume of 8-10 ml/min. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA status I and II
Key exclusion criteria (1 listed)
- Pregnant woman Obese patient (BMI>30kgm-2) oropharyngeal or facial anomalies anticipated difficult mask ventilation upper respiratory tract infection history of gastric surgery patient refusal
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 |
|---|---|---|
| Diagnostic ultrasonography of gastric volumeUltrasonic measurement of gastric insufflation during positive pressure ventilation (secondary endpoint) and final gastric volume after positive pressure ventilation (primary endpoint) | Other | Manual-controlled, Pressure-controlled, Volume-controlled |
Primary outcome
Gastric volume before and after positive pressure ventilation
Time frame: 15 minutes
1 secondary outcome
Ultrasonographic detection of gastric insufflation during ventilation
Time frame: 15 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2017.
- Individual participant dataSharing planned: Undecided
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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.
Pierre LAFERE, MD,PhD principal investigator
CHRU de Brest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic ultrasonography of gastric volume in people with Positive-Pressure Respiration and Respiratory Aspiration of Gastric Content, run by University Hospital, Brest at 1 site in France.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 17 Jul 2017. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierre LAFERE, MD, PhD (0033298347658, pierre.lafere@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric volume before and after positive pressure ventilation (time frame: 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jul 2017.