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

Recruiting

Conditions: narrowing of the airway
10046304
airway injury

Registration Number: NL-OMON41240

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 150

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 < III

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

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome parameters are injury or any pathology of the airway caused by<br /><br>cuffed versus uncuffed endotracheal tubes after prolonged tracheal intubation,<br /><br>detected by direct laryngo-tracheoscopy. </p><br>

Secondary Outcome Measures

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