Patient Comfort During High Flow Nasal Cannula Versus Nasal Continuous Airway Pressure (CPAP)
Patient Comfort During High Flow Nasal Cannula (HFNC)Versus Nasal Continuous Airway Pressure (CPAP): a Cross Over Randomised Trial
Preterm children are at increased risk for developing lung disease due to immature lungs. Non-invasive ventilation (NIV) support is increasingly used as treatment. Nasal continuous positive airway pressure (nCPAP) is the most common NIV-mode. Recently, high flow nasal cannulas (HFNC) have become an alternative NIV-mode. Both nCPAP and HFNC provide increased pressure in the airways aiming to keep the lungs open. With nCPAP it is common to use short binasal prongs that fill the nostrils completely and are pressed tightly over the nose. With HFNC oxygen/air is administered via two small, thin cannulas located just inside the nostrils, but the nostrils are not blocked.
The aim of this study is to compare patient comfort in premature infants treated with nCPAP and HFNC. The investigators hypothesis is that HFNC increases patient comfort.
The study is a randomized cross over study (2 x 24 hours). Children eligible for inclusion should be born before 34 weeks of gestation and have moderate respiratory distress, thus be "in need" of nCPAP. During the study period (48 hours) the investigators will consider how the child tolerates treatment with nCPAP versus HFNC. Primary outcome is patient comfort assessed with the EDIN-score (Neonatal pain and comfort score). Secondary outcomes are stress hormone response (cortisol in saliva), surrounding noise and parental satisfaction. The child's breathing pattern will be carefully monitored. The study involves no extra painful investigations.
The investigators plan to recruit 20 patients.
Panoramica dello studio
Stato
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
-
Tromsø, Norvegia, N-9038
- University Hospital of North Norway
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
Preterm infants admitted to the NICU at University Hospital of North Norway, Tromsoe, Norway (single center study)
- Gestational age (GA) < 34 weeks
- Corrected age < 34 weeks
- Receiving nasal CPAP for respiratory distress
- Respiratory "stable": FiO2 < 30%, pCO2 < 8,5 kPa and pH > 7.25.
- GA < 29 weeks: Respiratory "stable" over last 72 h.
- GA 29-33 weeks: Respiratory "stable" over last 24 h.
Exclusion Criteria:
- Congenital anomalies
- Ongoing treatment for hypoglycemia or infection
- Other intercurrent disease requiring frequent blood sampling
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: HFNC
High flow nasal cannula
|
In the cross over study 2 types of respiratory support are compared; HFNC versus nCPAP
Altri nomi:
In the cross over study 2 types of respiratory support are compared; HFNC versus nCPAP
Altri nomi:
|
|
Comparatore attivo: nCPAP
Nasal CPAP
|
In the cross over study 2 types of respiratory support are compared; HFNC versus nCPAP
Altri nomi:
In the cross over study 2 types of respiratory support are compared; HFNC versus nCPAP
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Patient comfort (EDIN score)
Lasso di tempo: 48 h (CPAP 24 h and HFNC 24 h); cumulative EDIN score for each 24 epoch is calculated and a change between the two interventions are assessed
|
EDIN score (neonatal pain and comfort score) is a validated scoring system to assess pain and comfort in term and preterm infants.
The cumulative EDIN score, based on three evaluations/24 h, is recorded for each 24 h epoch with HFNC or CPAP, respectively.
The change in EDIN score between the two 24 h epochs are assessed.
|
48 h (CPAP 24 h and HFNC 24 h); cumulative EDIN score for each 24 epoch is calculated and a change between the two interventions are assessed
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Noise
Lasso di tempo: Measured at 10 AM and 10 PM over 48 h (4 measurements)
|
Surrounding noise (dB)is measured twice daily during the 2 x 24 (48) h study period; twice during CPAP and twice during HFNC.
|
Measured at 10 AM and 10 PM over 48 h (4 measurements)
|
|
Parental satisfaction
Lasso di tempo: Three questions answered after 24 h and 48 h
|
3 questions related to parental satisfaction are asked by the end of each 24 h epoch with either CPAP or HFNC.
|
Three questions answered after 24 h and 48 h
|
|
Stress hormone response (salivary cortisol)
Lasso di tempo: Measured at 10 AM and 10 PM over 48 h (4 measurements)
|
Salivary cortisol is used as a marker of stress hormone response.
Salivary cortisol is collected twice (10 AM and 10 PM) for every 24 h epoch; a total of 4 measurements.
|
Measured at 10 AM and 10 PM over 48 h (4 measurements)
|
Collaboratori e investigatori
Investigatori
- Investigatore principale: Claus Klingenberg, MD, PhD, University Hospital of North Norway, Tromsø, Norway
Pubblicazioni e link utili
Pubblicazioni generali
- Wilkinson D, Andersen C, O'Donnell CP, De Paoli AG. High flow nasal cannula for respiratory support in preterm infants. Cochrane Database Syst Rev. 2011 May 11;(5):CD006405. doi: 10.1002/14651858.CD006405.pub2.
- Klingenberg C, Pettersen M, Hansen EA, Gustavsen LJ, Dahl IA, Leknessund A, Kaaresen PI, Nordhov M. Patient comfort during treatment with heated humidified high flow nasal cannulae versus nasal continuous positive airway pressure: a randomised cross-over trial. Arch Dis Child Fetal Neonatal Ed. 2014 Mar;99(2):F134-7. doi: 10.1136/archdischild-2013-304525. Epub 2013 Nov 13.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2011-2019 REK NORD
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .