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Gerandomiseerde cross-over studie naar het verschil in hoeveelheid lek bij het gezichtsmasker en het neusmasker tijdens beademing: Een pilot studie.


- candidate number14254
- NTR NumberNTR3814
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR23-jan-2013
- Secondary IDsP12.133 METC LUMC
- Public TitleGerandomiseerde cross-over studie naar het verschil in hoeveelheid lek bij het gezichtsmasker en het neusmasker tijdens beademing: Een pilot studie.
- Scientific TitleRandomized crossover comparison of mask leak between facemask and nasal mask ventilation: A pilot study.
- ACRONYMTesting Interfaces in Neonates. (TIN)
- hypothesisTo compare the occurrence of significant mask leak when using a nasal mask versus a facemask in preterm infants needing positive pressure ventilation.
- Healt Condition(s) or Problem(s) studiedMask ventilation, Leakage
- Inclusion criteriaPreterm born infants requiring non-emergency intubation during admission on the Neonatal Intensive Care Unit.
- Exclusion criteriaPreterm born infants who need immediate intubation in resuscitation setting or who have facial, laryngeal of pharyngeal malformations.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-okt-2012
- planned closingdate1-jul-2013
- Target number of participants40
- InterventionsRandomised cross-over study during which the neonate is ventilated with a nasal mask for 1 minute and face mask for 1 minute.
- Primary outcomePercentage of inflations with a large amount (> 60%) of leak.
- Secondary outcomeThe administered tidal volumes and the incidence of obstruction.
- TimepointsN/A
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Jeroen Vonderen, van
- CONTACT for SCIENTIFIC QUERIES Jeroen Vonderen, van
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Willem-Alexander Children's Foundation scholarship
- PublicationsN/A
- Brief summaryThe 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.
- Main changes (audit trail)
- RECORD23-jan-2013 - 4-feb-2013


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