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Nasal HFOV Versus Nasal CPAP to Reduce Post-extubation pCO2

21. juli 2020 oppdatert av: Christoph Czernik, Charite University, Berlin, Germany

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

To investigate whether nasal high frequency oscillation ventilation (nHFOV) immediately after extubation reduces the arterial partial pressure of carbon dioxide (paCO2) at 72 hours after extubation in comparison with nasal continuous positive airway pressure (nCPAP) in very low birth weight infants (VLBWs).

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

6

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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Studiesteder

  • Tyskland
      • Berlin, Tyskland
        • Dpt. of Neonatology, Charité - Universitätsmedizin Berlin

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

5 dager til 4 uker (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Enhet: nHFOV
Extubation to ventilator-derived nHFOV using binasal prongs
Aktiv komparator: 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.
Enhet: nCPAP
Extubation to ventilator-derived nCPAP using binasal prongs

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
paCO2 at 72 h After Extubation
Tidsramme: 64 h to 80 h
Partial pressure of arterial carbon dioxide assessed between 64 and 80 hours, and on average 72 hours.
64 h to 80 h

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
pH at 2 h After Extubation
Tidsramme: within the first 6 h after extubation
within the first 6 h after extubation
paO2 at 2 h After Extubation
Tidsramme: within the first 6 h after extubation
within the first 6 h after extubation
paCO2 at 2 h After Extubation
Tidsramme: within the first 6 h after extubation
within the first 6 h after extubation
Base Excess at 2 h After Extubation
Tidsramme: within the first 6 h after extubation
within the first 6 h after extubation
pH at 72 h After Extubation
Tidsramme: 64-80 h after extubation
64-80 h after extubation
paO2 at 72 h After Extubation
Tidsramme: 64-80 h after extubation
64-80 h after extubation
Base Excess at 72 h After Extubation
Tidsramme: 64-80 h after extubation
64-80 h after extubation
Successful Extubation
Tidsramme: 72 h after extubation
Defined as the number of patients breathing spontaneously in their assigned treatment group for ≥72h without reaching the criterion of "treatment failure"
72 h after extubation
Treatment Failure
Tidsramme: within 7 days after extubation
Defined as the number of patients reaching the criterion of "treatment failure"
within 7 days after extubation
Reintubation
Tidsramme: within 7 days after extubation
Defined as the number of patients being reintubated
within 7 days after extubation
Highly Viscous Secretions
Tidsramme: within 72 hours after extubation
Defined as the documented number of episodes of airway obstruction due to highly viscous secretions per patient
within 72 hours after extubation
Other Adverse Effects
Tidsramme: until discharge
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
until discharge
Duration of Respiratory Support
Tidsramme: until discharge
Total duration of mechanical ventilation, total duration of supplemental oxygen, number of infants discharged with home oxygen
until discharge

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
pH at 2 h After Switch to "Rescue Treatment"
Tidsramme: within the first 6 h after switch to "rescue treatment"
within the first 6 h after switch to "rescue treatment"
paO2 at 2 h After Switch to "Rescue Treatment"
Tidsramme: within the first 6 h after switch to "rescue treatment"
within the first 6 h after switch to "rescue treatment"
paCO2 at 2 h After Switch to "Rescue Treatment"
Tidsramme: within the first 6 h after switch to "rescue treatment"
within the first 6 h after switch to "rescue treatment"
Base Excess at 2 h After Switch to "Rescue Treatment"
Tidsramme: within the first 6 h after switch to "rescue treatment"
within the first 6 h after switch to "rescue treatment"
Successful Rescue
Tidsramme: 72 h after switch to "rescue" treatment
Defined as spontaneous breathing for ≥72h after starting "rescue" therapy, without reaching the criterion of "treatment failure"
72 h after switch to "rescue" treatment

Samarbeidspartnere og etterforskere

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Sponsor

Charite University, Berlin, Germany

Etterforskere

  • Hovedetterforsker: Christoph Czernik, MD PhD, Charite University, Berlin, Germany

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. januar 2015

Primær fullføring (Faktiske)

31. desember 2017

Studiet fullført (Faktiske)

31. desember 2017

Datoer for studieregistrering

Først innsendt

10. januar 2015

Først innsendt som oppfylte QC-kriteriene

13. januar 2015

Først lagt ut (Anslag)

16. januar 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. august 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. juli 2020

Sist bekreftet

1. juli 2020

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • EA2/011/12

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