No registrations found.
ID
Source
Brief title
Health condition
Mask leak during mask ventilation.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Percentage of inflations with a large amount (> 60%) of leak.
Secondary outcome
The administered tidal volumes and the incidence of obstruction.
Background summary
The most frequent used interface during resuscitation with the self-inflating bag or a mechanical T-piece device, is the facemask. Studies have shown that inadequate sealing between face and mask often leads to inappropriate and inconsistent peak inspiratory pressures (PIP) and positive end expiratory pressure (PEEP), which may be harmful. Effective resuscitation at birth may improve clinical outcome in preterm infants.
Segedin et al. showed that manual ventilation can be better performed via the nasal route. It has been shown that delivery of positive pressure ventilation though the nasal route via nasal prongs is favourable in terms of outcome (chest compressions and intubation) compared to delivery through a face mask.
There however is limited evidence that other device who use the nasal route, deliver efficient PIP and PEEP during resuscitation by decreasing the amount of leak. Examples of these devices are the nasal canula and the nasal mask. The applicability of these devices will alleviate the dependence on sufficient sealing by a facemask, providing that both the mouth and the other nostril are closed during resuscitation.
The nasal mask is often used in the unit as interface to deliver non-invasive respiratory support (continuous positive airway pressure (CPAP) or nasal intermittent mandatory ventilation). In other units it is used to deliver respiratory support in preterm infants at birth. However, so far the effectiveness of the nasal mask has not been tested and compared with the facial mask. To create rationale for a larger clinical trial we wish to perform a small pilot study comparing the effectiveness of a nasal mask with the standard facemask in preterm infants needing positive pressure ventilation.
Study objective
To compare the occurrence of significant mask leak when using a nasal mask versus a facemask in preterm infants needing positive pressure ventilation.
Study design
N/A
Intervention
Randomised cross-over study during which the neonate is ventilated with a nasal mask for 1 minute and face mask for 1 minute.
Postal zone J6-S
Jeroen Vonderen, van
Albinusdreef 2
Leiden 2300 RC
The Netherlands
+31 (0)71 5264987
j.j.van_vonderen@lumc.nl
Postal zone J6-S
Jeroen Vonderen, van
Albinusdreef 2
Leiden 2300 RC
The Netherlands
+31 (0)71 5264987
j.j.van_vonderen@lumc.nl
Inclusion criteria
Preterm born infants requiring non-emergency intubation during admission on the Neonatal Intensive Care Unit.
Exclusion criteria
Preterm born infants who need immediate intubation in resuscitation setting or who have facial, laryngeal of pharyngeal malformations.
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 | NL3668 |
NTR-old | NTR3814 |
Other | METC LUMC : P12.133 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |