No registrations found.
ID
Source
Brief title
Health condition
Mechanically ventilated children.
Sponsors and support
VU University Medical Center
Postbus 7057
1007 MB Amsterdam
Intervention
Outcome measures
Primary outcome
Detubation failure.
Secondary outcome
1. Use of other therapies to reduce upper airway obstruction (epinephrin, beclomethasone);
2. Croup score;
3. Supplemental oxygen;
4. Adverse effects of dexamethason: hypertension, Gatro-intestinal tract bleeding, hyperglycaemia.
Background summary
Upper airway obstrection is frequently seen (30%) after detubation in children at risk (4 weeks-4years, and prolonged intabation > 24 hours). There is often a need for reintubation (5%). Dexamethason may reduce the the frequency of upper airway obstruction and the need for reintubation. This has been studied earlier, however there is a lack of properly designed studies.
Study objective
Dexamethason reduces the rate of detubation failure in children at risk.
Study design
N/A
Intervention
Dexamethason 6 x 0,5 mg/kg i.v. à 6 uur (max 10 mg dose) first dose 6 - 12 hours prior to detubation.
Placebo: Saline (NaCl 0,9%).
P.O. Box 7057
M. Heerde, van
Amsterdam 1007 MB
The Netherlands
+31 (0)20 4444426 / +31 (0)20 4443000
m.vanheerde@vumc.nl
P.O. Box 7057
M. Heerde, van
Amsterdam 1007 MB
The Netherlands
+31 (0)20 4444426 / +31 (0)20 4443000
m.vanheerde@vumc.nl
Inclusion criteria
1. Age 4 weeks - 4 years;
2. Intubated > 24 hours;
3. Informed consent.
Exclusion criteria
1. Known with one of the following diseases:
a. peptic ulcus;
b. diabetes mellitus;
c. osteoporosis;
d. adrenal insufficiency;
e. hypertension;
f. systemic yeast infection;
g. tuberculosis;
h. sepsis;
2. Glucocorticoid use the week before detubation;
3. Intubation for laryngotracheal infection;
4. Mechanical ventilation for upper airway obstruction;
5. Down syndrome.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL110 |
| NTR-old | NTR141 |
| Other | : N/A |
| ISRCTN | ISRCTN54608329 |