Diaphragmatic Work During HFNC and CPAP Support

NCT06249009 | Unknown

• 1 other identifier: AOI 2022 SAVY
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Respiratory Insufficiency in Children; Newborn Rds; Nasal Cannula; CPAP Ventilation

Keywords

Paediatric; HFNC; CPAP; work of breathing; primary support

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Variation in mean minimum EAdi (EAdi min) between different HFNC flows and between each HFNC flow and CPAP

  Minimal electrical activity of diaphragm will be recorded every minutes (up to 3 hours)

• Variations of heart rate between the different rates of HFNC and between each rate of HFNC and CPAP

  every 5 minutes during 3 hours

• Variations of respiratory rate between the different rates of HFNC and between each rate of HFNC and CPAP

  every 5 minutes during 3 hours

• Variations of oxygen saturation between the different rates of HFNC and between each rate of HFNC and CPAP

  every 5 minutes during 3 hours

• Variations of transcutaneous partial pressure of carbon dioxide between the different rates of HFNC and between each rate of HFNC and CPAP

  every 5 minutes during 3 hours

Study Arms (2)

CPAP-first group

ACTIVE COMPARATOR

After a wash out of 15 minutes with conventional oxygen therapy, CPAP with a Positive End -Expiratory Pressure of 7 cmH2O will be introduced, with an inspiratory oxygen fraction required for an oxygen saturation of 94%, during 30 minutes. The collection of EAdi min/max will be done every minutes over 30min as well as the collection of HR, Respiratory rate (RR), SpO2, while TCPCO2, distress respiratory score and pain score will be taken at M0 and M30.

Device: Non invasive ventilation

HFNC-first group

ACTIVE COMPARATOR

After a wash out of 15 minutes with conventional oxygenotherapy, increasing flow rates for up to 2 hours according to the following augmentation: * Initiation at a flow rate of 2 L/kg/min with FiO2 required to achieve SpO2≥94% (increase FiO2 if reliable SpO2 signal \<94% for 1 minute) for 30min. * Increase to 3 L/kg/min after the first 30min of ventilation and repeat the previously described experimental scheme. * Further increase to 4 L/kg/min after 30min of ventilation and repetition of the experimental scheme (if weight \< 16 kg). * Last increase to 5 L/kg/min after 30 min of ventilation and repetition of the experimental scheme (if weight \< 13 kg). The collection of EAdi min/max will be done every minutes over 30min as well as the collection of HR, RR, SpO2, while TCPCO2, distress respiratory score and pain score will be taken at M0 and M30.

Device: Non invasive ventilation

Interventions

Non invasive ventilation DEVICE

CPAP and increasing flows of HFNC will be compared during a 30-minutes period each

CPAP-first group; HFNC-first group

Eligibility Criteria

• Age: 34 Weeks - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Maquet Critical Care AB: collaborator
• Fisher and Paykel Healthcare: collaborator

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, France

RECRUITING

Related Publications (5)

• 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.

  PMID: 35707984 BACKGROUND

• 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 airway pressure (nCPAP) for the initial respiratory management of acute viral bronchiolitis in young infants: a multicenter randomized controlled trial (TRAMONTANE study). Intensive Care Med. 2017 Feb;43(2):209-216. doi: 10.1007/s00134-016-4617-8. Epub 2017 Jan 26.

  PMID: 28124736 RESULT

• 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, Renolleau S, Portefaix A, Douillard A, Cambonie G; GFRUP Respiratory Study Group. A multicenter randomized controlled trial of a 3-L/kg/min versus 2-L/kg/min high-flow nasal cannula flow rate in young infants with severe viral bronchiolitis (TRAMONTANE 2). Intensive Care Med. 2018 Nov;44(11):1870-1878. doi: 10.1007/s00134-018-5343-1. Epub 2018 Oct 21.

  PMID: 30343318 RESULT

• 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. doi: 10.1111/apa.12998. Epub 2015 Apr 13.

  PMID: 25759095 RESULT

• 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.

  PMID: 24846750 RESULT

MeSH Terms

Conditions

Pulmonary Atelectasis

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Nadia Savy

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

334.73.754.963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The included patients will then be randomized into two separate groups: a CPAP group with PEEP at 7 cmH2O for 30 minutes and an HFNC group with increasing flow rates from 2L/kg/min to 5 L/kg/min with 30 minutes of study for each flow. After a wash-out period of 15 minutes, according to the cross-over procedure, the patients will change groups in order to perform the remaining analysis.

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: February 8, 2024
• Study Start: November 27, 2023
• Primary Completion: November 27, 2025
• Study Completion: November 27, 2025
• Last Updated: February 8, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)