MAsk VEntilation With Paratracheal Pressure In Children. Para Tracheal Compression to Prevent Gastric Insufflation in Children

Surgery Clinical Trial

— MAVEPPIC  

Official title:

Para Tracheal Compression to Prevent Gastric Insufflation During Positive Pressure Ventilation With Facemask in Children Under General Anaesthesia: an Efficiency Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05279170
• Other study ID #: 2020_74
• Secondary ID: 2021-A01535-36
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2022
• Est. completion date: September 2023

Study information

• Verified date: February 2022
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: September 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 10 Years

Eligibility

Inclusion 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Anesthesia Intubation Complication
• Surgery

Intervention

Other:
• MAVEPPIC: MAsk VEntilation with Paratracheal Pressure In Children
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	We will perfom a unique measurement of gastric air artefact by ultrasonography after 2 minutes of positive pressure ventilation.
Secondary	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	Before the beginning of positive pressure ventilation during 1 minute
Secondary	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	Before the beginning of positive pressure ventilation and during 1 minute
Secondary	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	At the beginning of positive pressure ventilation and during two minutes