SurgeryMAVEPPICNCT05279170
MAsk VEntilation With Paratracheal Pressure In Children. Para Tracheal Compression to Prevent Gastric Insufflation in Children
A study testing MAVEPPIC: MAsk VEntilation with Paratracheal Pressure In Children in people with Surgery and Anesthesia Intubation Complication, run by University Hospital, Lille at 2 sites in France.
Trial summary
The use of cricoid pressure to prevent gastric aspiration or regurgitation in case of "full stomach" situation or emergency is still controversial in the adult population. Moreover this maneuver is no more recommended in children by some European pediatric anesthesia societies, because of a lack of evidence of its… Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- Surgery, Anesthesia Intubation Complication
- What is being tested?
- MAVEPPIC: MAsk VEntilation with Paratracheal Pressure In Children
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesFrance
- Study dates
- 6 Jun 2024to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 2 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children from 2 to 10 years of age who benefit from general anesthesia with or without intubation
- inhalation induction
- elective surgery
- ASA status 1 or 2
- consent of the child if he/she is able to express it
- consent of both parents and/or legal guardians
- socially insured
Who cannot join
- Child under 2 years old or > 10 years
- body weight is over 40 kgs
- ASA status 3 or higher
- Emergency surgery or unscheduled surgery
- scheduled ENT or esogastric surgery
- Achalasia of the esophagus or history of GERD pathology
Show all 11Show fewer
- History of esophageal surgery (NISSEN type)
- BMI indexed to age and sex showing childhood obesity
- Predictable mask ventilation difficulties
- History of Tracheostomy
- Child not insured by social security
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Hôpital Jeanne de Flandre - Pôle Anesthésie Réanimation Pédiatrique
Lille
Dina BERT, Dr, 0320446269, dina.bert@chru-lille.fr
- Recruiting
Hôpital Jeanne de Flandre - Pôle Anesthésie Réanimation Pédiatrique
Lille
Dina BERT, Dr, 03 20 44 62 69, dina.bert@chru-lille.fr
About this study
Official title: Para Tracheal Compression to Prevent Gastric Insufflation During Positive Pressure Ventilation With Facemask in Children Under General Anaesthesia: an Efficiency Study
The use of cricoid pressure to prevent gastric aspiration or regurgitation in case of "full stomach" situation or emergency is still controversial in the adult population. Moreover this maneuver is no more recommended in children by some European pediatric anesthesia societies, because of a lack of evidence of its protective effect against gastric aspiration and its possible adverse effects.
A new approach to occlude effectively the esophageal lumen has been recently described in adults and has shown its effectiveness to prevent gastric insufflation. But this maneuver has so far not been evaluated in the pediatric population and could be an alternative to prevent gastro-esophageal regurgitation and pulmonary aspiration in children
- Conditions
- Surgery, Anesthesia Intubation Complication
- Being tested
- MAVEPPIC: MAsk VEntilation with Paratracheal Pressure In Children
- Keywords
- Low Left Paratracheal esophagus Pressure, gastric insufflation, Echography, children, elective surgery, positive pressure ventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAVEPPIC: MAsk VEntilation with Paratracheal Pressure In ChildrenOther
Pressure will be applied with two fingers in the area located between the trachea and the sternal head of the sternocleidomastoid muscle on the left side to compress the cervical esophagus.
The force applied (after measuring the equivalent force applied on a precision scale) will be about 10 - 15 N. This force will be adapted according to the child's body weight : 10 N below 20 kgs and 15 N between 20 kgs and 40 kgs
| Study group | Role | What they receive |
|---|---|---|
| children | Experimental | Compression of adjacent vessels (jugular vein and carotid artery), near the left paratracheal area. The risk of compression of the vessels will be assessed before performing the maneuver.
At the screening time before the intervention, we will perfom an ultrasonography measurement while we applied the maneuver in order to eliminate a risk of compression of the vessels, defined as a reduction in diameter of 50%. Receives: Other: MAVEPPIC: MAsk VEntilation with Paratracheal Pressure In Children |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of air artefacts during positive pressure ventilation as evaluated by simultaneous gastric ultrasonography
Presence of antral and/or gastric air artefact described in ultrasonography. US will be perform during positive pressure mask ventilation.
Measured: We will perfom a unique measurement of gastric air artefact by ultrasonography after 2 minutes of positive pressure ventilation.
Secondary outcomes (3)
The verification of the actual position of the esophagus on the left side of the trachea at the place where LPPP will be applied (feasibility of LLPP)
Left side of the trachea ultrasonography performed before positive pressure ventilation
Measured: Before the beginning of positive pressure ventilation during 1 minute
The safety of the LLPP maneuver: absence of any significant compression of the adjacent vessels as measured by US.
Left side of the trachea ultrasonography performed before positive pressure ventilation
Measured: Before the beginning of positive pressure ventilation and during 1 minute
The expired tidal volume and peak inspiratory pressure as measured during PPV to evaluate any difficulty in mask ventilation induced by LLPP.
Expired tidal volume measured exhaled flow on anesthesia ventilator
Measured: At the beginning of positive pressure ventilation and during two minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start6 Jun 2024
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05279170
- Sponsor's protocol ID
- 2020_74
- Other IDs
- 2021-A01535-36
- Acronym
- MAVEPPIC
- Status last verified
- Dec 2025
- First submitted
- 24 Feb 2022
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Para Tracheal Compression to Prevent Gastric Insufflation During Positive Pressure Ventilation With Facemask in Children Under General Anaesthesia: an Efficiency Study
- ClinicalTrials.gov ID
- NCT05279170
- Acronym / sponsor ID
- MAVEPPIC / 2020_74
- Conditions
- Surgery, Anesthesia Intubation Complication
- Keywords
- Low Left Paratracheal esophagus Pressure, gastric insufflation, Echography, children, elective surgery, positive pressure ventilation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 6 Jun 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 15 Mar 2022 (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 use of cricoid pressure to prevent gastric aspiration or regurgitation in case of "full stomach" situation or emergency is still controversial in the adult population. Moreover this maneuver is no more recommended in children by some European pediatric anesthesia societies, because of a lack of evidence of its protective effect against gastric aspiration and its possible adverse effects.
A new approach to occlude effectively the esophageal lumen has been recently described in adults and has shown its effectiveness to prevent gastric insufflation. But this maneuver has so far not been evaluated in the pediatric population and could be an alternative to prevent gastro-esophageal regurgitation and pulmonary aspiration in children
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| children | Experimental | Other: MAVEPPIC: MAsk VEntilation with Paratracheal Pressure In ChildrenCompression of adjacent vessels (jugular vein and carotid artery), near the left paratracheal area. The risk of compression of the vessels will be assessed before performing the maneuver. At the screening time before the intervention, we will perfom an ultrasonography measurement while we applied the maneuver in order to eliminate a risk of compression of the vessels, defined as a reduction in diameter of 50%. |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Children from 2 to 10 years of age who benefit from general anesthesia with or without intubation
- inhalation induction
- elective surgery
- ASA status 1 or 2
- consent of the child if he/she is able to express it
Key exclusion criteria (11 listed)
- Child under 2 years old or > 10 years
- body weight is over 40 kgs
- ASA status 3 or higher
- Emergency surgery or unscheduled surgery
- scheduled ENT or esogastric surgery
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 |
|---|---|---|
| MAVEPPIC: MAsk VEntilation with Paratracheal Pressure In ChildrenPressure will be applied with two fingers in the area located between the trachea and the sternal head of the sternocleidomastoid muscle on the left side to compress the cervical esophagus. The force applied (after measuring the equivalent force applied on a precision scale) will be about 10 - 15 N. This force will be adapted according to the child's body weight : 10 N below 20 kgs and 15 N between 20 kgs and 40 kgs | Other | children |
Primary outcome
Presence of air artefacts during positive pressure ventilation as evaluated by simultaneous gastric ultrasonography
Time frame: We will perfom a unique measurement of gastric air artefact by ultrasonography after 2 minutes of positive pressure ventilation.
Presence of antral and/or gastric air artefact described in ultrasonography. US will be perform during positive pressure mask ventilation.
3 secondary outcomes
The verification of the actual position of the esophagus on the left side of the trachea at the place where LPPP will be applied (feasibility of LLPP)
Time frame: Before the beginning of positive pressure ventilation during 1 minute
The safety of the LLPP maneuver: absence of any significant compression of the adjacent vessels as measured by US.
Time frame: Before the beginning of positive pressure ventilation and during 1 minute
The expired tidal volume and peak inspiratory pressure as measured during PPV to evaluate any difficulty in mask ventilation induced by LLPP.
Time frame: At the beginning of positive pressure ventilation and during two minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
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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.
Hôpital Jeanne de Flandre - Pôle Anesthésie Réanimation Pédiatrique
Lille, France
Hôpital Jeanne de Flandre - Pôle Anesthésie Réanimation Pédiatrique
Lille, France
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MAVEPPIC: MAsk VEntilation with Paratracheal Pressure In Children in people with Surgery and Anesthesia Intubation Complication, run by University Hospital, Lille at 2 sites 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 7 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of air artefacts during positive pressure ventilation as evaluated by simultaneous gastric ultrasonography (time frame: We will perfom a unique measurement of gastric air artefact by ultrasonography after 2 minutes of positive pressure ventilation.). 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 26 Dec 2025.