Endoscopic evaluation of the paediatric airway after prior prolonged (>24 h) tracheal intubation, a multicenter study.

Endoscopic evaluation of the paediatric airway after prior prolonged (>24 h) tracheal intubation, a multicenter study. - PAAPI (paediatric airway after prolonged intubation)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON41240

Enrollment

150

Registered

2014-09-22

Start date

2015-03-31

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

airway injury narrowing of the airway

Interventions

None listed

Eligibility

Age

2 Years to 17 Years

Inclusion criteria

Inclusion criteria: Children, aged 1 month to 16 yrs having prior prolonged (>= 24h) tracheal intubation during ICU-stay within the study centre, who are scheduled for elective intervention such as surgery or diagnostics procedures requiring general anaesthesia with airway instrumentation involving muscle paralysis. Children for diagnosis or treatment of stridor are also included • No known risk for regurgitation • Written parental consent • ASA physical status

Exclusion criteria

Exclusion criteria: No parental written consent • Known airway anomalies associated with syndromes or diseases such as TEF and CDH • Known or suspected difficult intubation • Emergency surgery or intervention • Full stomach and/or at risk for regurgitation • ASA physical status IV and higher • Patients with current or prior tracheostomy • Known, suspected or potential cervical spine pathology (e.g. Down*s Syndrome) • Insufficient clinical details from previous prolonged intubation

Design outcomes

Primary

Measure	Time frame
Primary outcome parameters are injury or any pathology of the airway caused by cuffed versus uncuffed endotracheal tubes after prolonged tracheal intubation, detected by direct laryngo-tracheoscopy.	—

Secondary

Measure	Time frame
Secondary outcome parameters are other risk factors which might contribute to airway injury in intubated children. These factors are the brand of the tube, the route of intubation (oral or nasal), and tube size. Further factors are prematurity, age and weight of the patient, the reason for prolonged intubation such as cardiac failure, respiratory failure, sepsis, postoperative ventilation or other, presence of airway infection or shock during intubation. Also adverse events during intubation such as accidental extubation, reintubation, hemodynamic compromise and sepsis will be recorded.	—

Measure

Time frame

Secondary outcome parameters are other risk factors which might contribute to airway injury in intubated children. These factors are the brand of the tube, the route of intubation (oral or nasal), and tube size. Further factors are prematurity, age and weight of the patient, the reason for prolonged intubation such as cardiac failure, respiratory failure, sepsis, postoperative ventilation or other, presence of airway infection or shock during intubation. Also adverse events during intubation such as accidental extubation, reintubation, hemodynamic compromise and sepsis will be recorded.

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Countries

Netherlands

Outcome results