CompletedNot Applicable

Cuff Pressure Regulation Apparatus for Tracheal Intubation in Children

France44 participantsStarted 2020-08-12

Plain-language summary

Despite the expert recommendation about rigorous monitoring of tracheal cuff pressure using a continuous or intermittent technique, cuff underinflation and overinflation are common increasing the risk of microinhalation and tracheal ischemia. All these complications are associated with high morbidity and mortality in ICU.

Who can participate

Age range2 Days – 5 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Infants and children more than 2 days after birth at term and less than 5 years of age * Patient intubated in the PICU with a cuffed endotracheal tube * Predicted duration of mechanical ventilation \> or = 24-hours * Signed informed consent Exclusion Criteria: * Intubated with an uncuffed endotracheal tube * Children admitted to the PICU with a previous tracheostomy * Preterm children or infants less than 2 days post-term * Patient under block neuromuscular treatment * Patient enrolled in another trial that might influence this study results

What they're measuring

Percentage of time spend with over or under-inflation of the tracheal cuff

Timeframe: 12 hours

Trial details

NCT IDNCT04413318

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-04-16

View on ClinicalTrials.gov More Cuff Overinflation trials