Nasal HFOV Versus Nasal CPAP to Reduce Post-extubation pCO2
Nasal High Frequency Oscillation Ventilation Versus Nasal Continuous Positive Airway Pressure to Reduce Post-extubation pCO2 in Very Low Birth Weight Infants: a Randomized Controlled Trial
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Randomized controlled clinical trial comparing nHFOV vs nCPAP immediately after extubation of VLBW infants.
Intervention and treatment protocol as described for the two study arms.
Definition of treatment failure (infant meets at least one criterion):
- Sustained pCO2 >80 mmHg and pH <7.20 confirmed by arterial or capillary blood gas analysis in spite of optimized non-invasive respiratory support with maximum settings as defined above.
- Fraction of inspired oxygen (FiO2) >0.6 to maintain peripheral oxygen saturation as measured by pulse oximetry (SpO2) at 90-94% in spite of optimized non-invasive respiratory support with maximum settings as defined above.
- Reintubation (study patients may be intubated at any time, due to clinical considerations, with or without reaching another criterion of "treatment failure").
Sample size:
Assuming a variability of the paCO2 as previously reported for difficult-to-wean preterm infants in our unit (Czernik C, J Matern Fetal Neonatal Med 2012) and a treatment failure rate of 22% within 72 hours after extubation, we calculated a sample size of 34 patients in each study arm to detect a difference in the paCO2 of 7 mmHg, using a two-sided significance of 0.05 and a power of 0.8.
Randomization:
Sequence generation by an independent statistician and a study nurse. Block randomization using at least two different block sizes. Allocation concealment using sequentially numbered opaque sealed envelopes.
Data monitoring:
By an independent statistician.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Berlin, Alemanha
- Dpt. of Neonatology, Charité - Universitätsmedizin Berlin
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Gestational age <32+0 weeks
- Birth weight <1500 g
- Received mechanical ventilation via an endotracheal tube for ≥120 h
- Caffeine treatment according to unit guidelines
- paCO2 <65 mmHg with pH >7.2
- FiO2 25-40% to maintain SpO2 at 90-94%.
- Time-cycled, pressure-controlled ventilation: PIP ≤22 cm H2O, PEEP ≤6 cm H2O; Volume guarantee ventilation: Working Ppeak ≤22 cm H2O, PEEP ≤6 cm H2O; High frequency oscillation ventilation: Pmean ≤12 cm H2O, Amplitude ≤30 cm H2O
- Decision of the attending clinician to extubate
Exclusion Criteria:
- Major congenital malformation requiring surgery
- Duct-dependent congenital heart disease
- Neuromuscular disease
- Participation in another randomized controlled trial
- Death before reaching the eligibility criteria
- Hydrocortisone treatment at the time of enrolment
- Chronological age >28 days
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: nHFOV
Immediately after extubation, nHFOV is provided via binasal prongs. Ventilator settings: Frequency set at 10 Hz, I:E ratio 33:66, amplitude 20 cm H2O, Pmean 8 cm H2O, flow 7 l/min. Set FiO2 to maintain SpO2 at 90-94%. The weaning process is left to the discretion of the attending physician. Maximum amplitude 30 cm H2O, minimum frequency 9 Hz, maximum Pmean 8 cm H2O. For infants in the nHFOV-group who "fail" nHFOV (see definition below), but do not need immediate reintubation, a non-invasive "Rescue-Treatment" may be provided. The decision to attempt "Rescue-Treatment", the mode of respiratory support and the ventilator settings used are at the discretion of the attending clinician. |
Extubation to ventilator-derived nHFOV using binasal prongs
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Comparador Ativo: nCPAP
Immediately after extubation, nCPAP is provided via binasal prongs. Ventilator settings: CPAP level set at 8 cm H2O, flow 7 l/min. Set FiO2 to maintain SpO2 at 90-94%. The weaning process is left to the discretion of the attending physician. Maximum CPAP level 8 cm H2O, maximum flow 8 l/min. For infants in the nCPAP-group who "fail" nCPAP (see definition below), but do not need immediate reintubation, "Rescue-nHFOV" via binasal prongs may be provided. The decision to attempt "Rescue-nHFOV" and the ventilator settings used are at the discretion of the attending clinician. |
Extubation to ventilator-derived nCPAP using binasal prongs
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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paCO2 at 72 h After Extubation
Prazo: 64 h to 80 h
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Partial pressure of arterial carbon dioxide assessed between 64 and 80 hours, and on average 72 hours.
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64 h to 80 h
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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pH at 2 h After Extubation
Prazo: within the first 6 h after extubation
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within the first 6 h after extubation
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paO2 at 2 h After Extubation
Prazo: within the first 6 h after extubation
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within the first 6 h after extubation
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paCO2 at 2 h After Extubation
Prazo: within the first 6 h after extubation
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within the first 6 h after extubation
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Base Excess at 2 h After Extubation
Prazo: within the first 6 h after extubation
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within the first 6 h after extubation
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pH at 72 h After Extubation
Prazo: 64-80 h after extubation
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64-80 h after extubation
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paO2 at 72 h After Extubation
Prazo: 64-80 h after extubation
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64-80 h after extubation
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Base Excess at 72 h After Extubation
Prazo: 64-80 h after extubation
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64-80 h after extubation
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Successful Extubation
Prazo: 72 h after extubation
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Defined as the number of patients breathing spontaneously in their assigned treatment group for ≥72h without reaching the criterion of "treatment failure"
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72 h after extubation
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Treatment Failure
Prazo: within 7 days after extubation
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Defined as the number of patients reaching the criterion of "treatment failure"
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within 7 days after extubation
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Reintubation
Prazo: within 7 days after extubation
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Defined as the number of patients being reintubated
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within 7 days after extubation
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Highly Viscous Secretions
Prazo: within 72 hours after extubation
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Defined as the documented number of episodes of airway obstruction due to highly viscous secretions per patient
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within 72 hours after extubation
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Other Adverse Effects
Prazo: until discharge
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Incidences of the following adverse effects: Intraventricular hemorrhage III°-IV° (Papile), surgical necrotizing enterocolitis, pneumothorax, pulmonary interstitial emphysema, persistent ductus arteriosus requiring surgical closure, retinopathy of prematurity requiring laser treatment and/or injection of bevacizumab, death or moderate to severe bronchopulmonary dysplasia (Jobe) at 36 weeks' gestational age, periventricular leukomalacia
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until discharge
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Duration of Respiratory Support
Prazo: until discharge
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Total duration of mechanical ventilation, total duration of supplemental oxygen, number of infants discharged with home oxygen
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until discharge
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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pH at 2 h After Switch to "Rescue Treatment"
Prazo: within the first 6 h after switch to "rescue treatment"
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within the first 6 h after switch to "rescue treatment"
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paO2 at 2 h After Switch to "Rescue Treatment"
Prazo: within the first 6 h after switch to "rescue treatment"
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within the first 6 h after switch to "rescue treatment"
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paCO2 at 2 h After Switch to "Rescue Treatment"
Prazo: within the first 6 h after switch to "rescue treatment"
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within the first 6 h after switch to "rescue treatment"
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Base Excess at 2 h After Switch to "Rescue Treatment"
Prazo: within the first 6 h after switch to "rescue treatment"
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within the first 6 h after switch to "rescue treatment"
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Successful Rescue
Prazo: 72 h after switch to "rescue" treatment
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Defined as spontaneous breathing for ≥72h after starting "rescue" therapy, without reaching the criterion of "treatment failure"
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72 h after switch to "rescue" treatment
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Christoph Czernik, MD PhD, Charite University, Berlin, Germany
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- EA2/011/12
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