Respiratory Insufficiency in Children Clinical Trial
— DiaWorkHFNCOfficial title:
Impact of Increasing Flow Rates in High-flow Nasal Cannula and CPAP on Diaphragmatic Work in Newborn and Paediatric Population: Non-inferiority Study
The goal of this randomised controlled, cross-over clinical trial is to compare High Flow Nasal Cannulas (HFNC) and Continuous Positive Airways Pressure (CPAP) in neonates over 34 weeks' amenorrhoea (SA) up to children weighing less than 20 kg with respiratory failure. The main question it aims to answer is the non-inferiority of high flows of high-flow nasal cannula compared with CPAP by analysis of diaphragmatic contraction (EAdi (Electrical activity of diaphragm)). Participants with respiratory failure and need of non invasive ventilation and nasogastric tube will receive 4 different increasing flows of HFNC and Positive End-Expiratory Pressure of 7 cmH2O with CPAP during 30 minutes for each flow rate and CPAP. The electrical activity of diaphragm and clinical data of the patient upon each flow and support will be collected. According to the cross-over procedure, the patients will change groups (increasing flows of HFNC or CPAP) in order to perform the remaining analysis.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | November 27, 2025 |
Est. primary completion date | November 27, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 34 Weeks to 6 Years |
Eligibility | Inclusion Criteria: - Newborns over 34 SA and paediatric patients weighing less than 20 kg. - Need for ventilatory support by HFNC or CPAP for respiratory failure - Need for enteral feeding via nasogastric tube - Hospitalized in PICU or NICU at Clermont-Ferrand University Hospital, - Covered by Social Security. - Whose parents or guardians are able to provide informed consent to participate in the research. Exclusion Criteria: - Respiratory failure requiring immediate intubation. - Use of HFNC or CPAP as a relay to extubation. - Acquired or congenital abnormality of the gastrointestinal tract. - Diaphragmatic paralysis and/or neuromuscular pathology - Failure of central ventilatory control (e.g. intra-ventricular haemorrhage, anoxic-ischaemic encephalopathy, massive vascular accident, intracranial process, cerebral edema and/or intracranial hypertension). - Contraindications listed in the CPAP and HFNC user manuals: absence of spontaneous ventilation, choanal atresia, diaphragmatic hernia, tracheo-oesophageal fistula, nasal trauma, severe deformity likely to be aggravated by the nasal mask or nasal cannula, pneumothorax, pneumencephaly, Cerebrospinal Fluid leak, hypotension. - Refusal by parents or guardians. |
Country | Name | City | State |
---|---|---|---|
France | CHU Clermont-Ferrand | Clermont-Ferrand |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Clermont-Ferrand | Fisher and Paykel Healthcare, Maquet Critical Care AB |
France,
Milesi C, Essouri S, Pouyau R, Liet JM, Afanetti M, Portefaix A, Baleine J, Durand S, Combes C, Douillard A, Cambonie G; Groupe Francophone de Reanimation et d'Urgences Pediatriques (GFRUP). High flow nasal cannula (HFNC) versus nasal continuous positive — View Citation
Milesi C, Pierre AF, Deho A, Pouyau R, Liet JM, Guillot C, Guilbert AS, Rambaud J, Millet A, Afanetti M, Guichoux J, Genuini M, Mansir T, Bergounioux J, Michel F, Marcoux MO, Baleine J, Durand S, Durand P, Dauger S, Javouhey E, Leteurtre S, Brissaud O, Re — View Citation
Nasef N, El-Gouhary E, Schurr P, Reilly M, Beck J, Dunn M, Ng E. High-flow nasal cannulae are associated with increased diaphragm activation compared with nasal continuous positive airway pressure in preterm infants. Acta Paediatr. 2015 Aug;104(8):e337-43 — View Citation
Pham TM, O'Malley L, Mayfield S, Martin S, Schibler A. The effect of high flow nasal cannula therapy on the work of breathing in infants with bronchiolitis. Pediatr Pulmonol. 2015 Jul;50(7):713-20. doi: 10.1002/ppul.23060. Epub 2014 May 21. — View Citation
Ramnarayan P, Richards-Belle A, Drikite L, Saull M, Orzechowska I, Darnell R, Sadique Z, Lester J, Morris KP, Tume LN, Davis PJ, Peters MJ, Feltbower RG, Grieve R, Thomas K, Mouncey PR, Harrison DA, Rowan KM; FIRST-ABC Step-Up RCT Investigators and the Paediatric Critical Care Society Study Group. Effect of High-Flow Nasal Cannula Therapy vs Continuous Positive Airway Pressure Therapy on Liberation From Respiratory Support in Acutely Ill Children Admitted to Pediatric Critical Care Units: A Randomized Clinical Trial. JAMA. 2022 Jul 12;328(2):162-172. doi: 10.1001/jama.2022.9615. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Variations of mean max electrical activity of the diaphragm (mean EAdi) between different HFNC flows and between each HFNC flow and CPAP | Maximal EAdi will be measured in µV | Maximal electrical activity of diaphragm will be recorded every minutes (up to 3 hours) | |
Secondary | Variation in mean minimum EAdi (EAdi min) between different HFNC flows and between each HFNC flow and CPAP | Minimum EAdi will be measured in µV | Minimal electrical activity of diaphragm will be recorded every minutes (up to 3 hours) | |
Secondary | Variations of heart rate between the different rates of HFNC and between each rate of HFNC and CPAP | Heart rate will be measured in beats per minute (bpm) | every 5 minutes during 3 hours | |
Secondary | Variations of respiratory rate between the different rates of HFNC and between each rate of HFNC and CPAP | Respiratory rate will be measured in breath per minute | every 5 minutes during 3 hours | |
Secondary | Variations of oxygen saturation between the different rates of HFNC and between each rate of HFNC and CPAP | Oxygen saturation will be measured in percentage | every 5 minutes during 3 hours | |
Secondary | Variations of transcutaneous partial pressure of carbon dioxide between the different rates of HFNC and between each rate of HFNC and CPAP | Transcutaneous partial pressure of carbon dioxide will be measured in mmHg | every 5 minutes during 3 hours | |
Secondary | Variations of respiratory distress score between the different rates of HFNC and between each rate of HFNC and CPAP | score of Silverman (0 to 10), or score modified Wood score (0 to 10) or score of PRAM (0 to 12) depending on the pathology | Every 30 minutes during 3 hours | |
Secondary | Incidence of minor side effects for each HFNC flow rate and for CPAP | bloating and/or gastrointestinal discomfort with no other associated cause, low-grade skin trauma | Every 30 minutes during 3 hours | |
Secondary | Incidence of major side effects for each flow of HFNC and for CPAP | Barotrauma to the chest, pneumothorax or pneumomediastinum
Bradycardia defined as : if < 1 year: Heart rate (HR) < 100 bpm for 20 seconds or < 60 bpm for 5 seconds if = 1 year: HR < 100 bpm for 20 seconds or < 40 bpm for 5 seconds Number of desaturations (oxygen saturation rate (SpO2) < 88% for 3s), apneas (breathing pause = 10s) High-grade skin trauma |
Every 30 minutes during 3 hours | |
Secondary | Intubation rate | through patient follow-up period, up to 3 hours | ||
Secondary | Ventilatory weaning time | Weaning from all types of pressure support | From date of randomization until the date of pressure weaning support, up to 30 days. |
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