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Official title MAsk VEntilation With Paratracheal Pressure In Children. Para Tracheal Compression to Prevent Gastric Insufflation in Children
ClinicalTrials.gov ID: NCT05279170
What this study is testing
- What it's testing
- 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 plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 10
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
- 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
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Lille, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 10 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lille, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.