RhDNase can liquefy mucus in children with an atelectasis during mechanical ventilation, resulting in improved mucociliary clearance, less mucus retention and less airways obstruction, thereby enhancing the rate of resolution of an atelectasis.…
ID
Bron
Verkorte titel
Aandoening
Atelectasis during mechanical ventilation.
Ondersteuning
3015 GJ Rotterdam
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Change in a Chest radiograph-score (CXR-score) at 48 hours.
Achtergrond van het onderzoek
Atelectasis in children during mechanical ventilation often results from and/or is associated with airway inflammation and airways infection, with an increased influx of inflammAatory cells in the airways. Inflammatory cells and damaged epithelial cells degrade, and release DNA in airway mucus resulting in an increased mucus viscosity. Viscous mucus impairs mucociliary clearance, resulting in airways obstruction and impaired resolution of atelectasis.
We therefore designed a study to evaluate the efficacy of the mucolytic medicine rhDNase in addition to conventional treatment in children with an atelectasis during mechanical ventilation.
Doel van het onderzoek
RhDNase can liquefy mucus in children with an atelectasis during mechanical ventilation, resulting in improved mucociliary clearance, less mucus retention and less airways obstruction, thereby enhancing the rate of resolution of an atelectasis. Moreover we expect the ventilator settings, pulmonary ventilation and ventilation-perfusion mismatch to improve faster, possibly resulting in a shorter time spent on a ventilator and on the ICU.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Intervention group: Twice daily: inhaled rhDNase, 2.5 ml and twice daily 4 ml isotonic saline (NaCl 0.9%), for two days.
Control group: Twice daily: inhaled isotinic saline 2.5 ml and twice daily 4 ml isotonic saline, for two days.
Publiek
P.O. Box 2060
R. Boogaard
Rotterdam 3000 CB
The Netherlands
+31 (0)10 4636683
r.boogaard@erasmusmc.nl
Wetenschappelijk
P.O. Box 2060
R. Boogaard
Rotterdam 3000 CB
The Netherlands
+31 (0)10 4636683
r.boogaard@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Age 0-18 years;
2. Mechanical ventilation;
3. Presence of an atelectasis on a chest radiograph;
4. First dose of study medication can be administered preferably within 6 hours (max 12 hours) after an atelectasis has been diagnosed.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Children with neuromuscular disorders and impaired ability to cough; cardiomyopathy; or cystic fibrosis;
2. Post-gestational age < 32 weeks;
3. Mechanical ventilation during muscle paralysis;
4. Atelectasis due to a bronchoscopically diagnosed:
- foreign body aspiration;
- tracheal or bronchial compression by lymph nodes or vessels;
5. Recurrent atelectasis due to an anatomical airway-abnormality;
6. RhDNase treatment in the previous 48 hours;
7. Clinical condition or ventilator settings that are not compatible with nebulizing medication (according to the responsible physician);
8. Presence of a pneumothorax;
9. Previous participation in the study.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL715 |
NTR-old | NTR725 |
Ander register | : N/A |
ISRCTN | ISRCTN07263575 |