Hemodynamic stable term and preterm neonates requiring semi-elective endotracheal intubation.
Conditions
Brief summary
Successful outcome is defined as adequate intubation with satisfactory sedation. Following each procedure: intubating conditions are graded immediately by the intubator with a scoring system based on criteria for good clinical research practice (GCRP) by Viby-Mogensen. Each assessment domain is allocated a score of 1-4. Good quality of intubation was defined as a score of ≤ 2 on each of the 5 items., The level of sedation is assessed with a sedation score (adopted from the study of Naulaers et al) performed by rubbing the sole of the subject’s foot and judging the motor reaction to that stimulus (1 = spontaneous movement; 2 = movement on slight touch; 3 = movement in reaction to firm stimulus; 4 = no movement).
Detailed description
safety end points: During the intubation procedure: predefined side effects such as bradycardia (heart rate less than 100 bpm), hypotension, respiratory depression, and chest wall rigidity are reviewed.., efficacy end points: ease of bag-mask ventilation and time to successful intubation, additional end points: time to return of spontaneous ventilation ; incidence of intraventricular hemorrhage ; blood gas values ; need for rescue medication
Interventions
DRUGUltiva 1 mg poeder voor concentraat voor oplossing voor injectie / infusie
DRUGNaCl 0
DRUG9 % B. Braun
DRUGoplossing voor injectie
Sponsors
Universitair Ziekenhuis Gent
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Successful outcome is defined as adequate intubation with satisfactory sedation. Following each procedure: intubating conditions are graded immediately by the intubator with a scoring system based on criteria for good clinical research practice (GCRP) by Viby-Mogensen. Each assessment domain is allocated a score of 1-4. Good quality of intubation was defined as a score of ≤ 2 on each of the 5 items., The level of sedation is assessed with a sedation score (adopted from the study of Naulaers et al) performed by rubbing the sole of the subject’s foot and judging the motor reaction to that stimulus (1 = spontaneous movement; 2 = movement on slight touch; 3 = movement in reaction to firm stimulus; 4 = no movement). | — |
Secondary
| Measure | Time frame |
|---|---|
| safety end points: During the intubation procedure: predefined side effects such as bradycardia (heart rate less than 100 bpm), hypotension, respiratory depression, and chest wall rigidity are reviewed.., efficacy end points: ease of bag-mask ventilation and time to successful intubation, additional end points: time to return of spontaneous ventilation ; incidence of intraventricular hemorrhage ; blood gas values ; need for rescue medication | — |
Countries
Belgium
Outcome results
None listed