Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06249009
Status:
RECRUITING
Last Update Posted:
2024-02-08
First Post:
2023-09-28
Brief Title:
Diaphragmatic Work During HFNC and CPAP Support
Sponsor:
University Hospital Clermont-Ferrand
Organization:
University Hospital Clermont-Ferrand
Study Overview
Official Title:
Impact of Increasing Flow Rates in High-flow Nasal Cannula and CPAP on Diaphragmatic Work in Newborn and Paediatric Population Non-inferiority Study
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DiaWorkHFNC
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
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
Detailed Description:
With this research protocol the investigators aim to demonstrate the non-inferiority of high flows of HFNC compared with CPAP on work of breathing based on the intensity of contraction of diaphragmatic fibres and clinical aspects in paediatric and neonatal patients The investigators will also study the clinical tolerance and safety of these practices
Objectives
Main objective To demonstrate the non-inferiority of high-flow nasal cannula flow rates compared with CPAP by analysis of diaphragmatic contraction EAdi Electrical activity of diaphragm in neonates over 34 weeks amenorrhoea SA up to children weighing less than 20 kg in respiratory failure
Secondary objectives
To compare different flows of HFNC 2 Lkgmin 3 Lkgmin 4 Lkgmin 5 Lkgmin with each other by analysing diaphragmatic contraction
Compare the clinical effectiveness of different flow rates of HFNC with CPAP in young children in respiratory distress
To compare the tolerability of different flow rates of HFNC with CPAP in the population of young children suffering from respiratory distress
To compare the incidence of minor digestive discomfort digestive bloating non-damaging skin lesions and major thoracic barotrauma damaging skin lesions side effects of different flow rates of HFNC with CPAP in young children in respiratory distress
To describe the choice of support and settings flow rates or PEEP levels made by the practitioners in charge of the child after the study period
To describe the epidemiological data from the paediatric intensive care and monitoring units and the neonatal intensive care unit
Type of study Randomised controlled cross-over single-centre non-inferiority trial of a medical device
Number of centres 1
Study design
Upon admission to the department if the eligibility criteria are met and the parents agree to the research a wash-out period will be performed under low-flow oxygen therapy at 1 Lmin to achieve SpO2 94 for 15 minutes
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 for up to 2 hours
The patients included will be their own controls and at the end of the first analysis according to the cross-over procedure the patients will change groups in order to perform the remaining analysis
A recourse procedure has been foreseen in case of failure of ventilatory support
Medical devices
Concerning HFNC ventilation
The nasal cannulas used are Optiflow cannulas Fisher and Paykel Laboratory which will be adapted to the size of each patients nostrils The following sizes are available
NICU patient Optiflow Junior 2
PICU patient Optiflow Junior 2 Optiflow
Concerning CPAP ventilation
For the neonatal population
Medin Sindi CPAP masks caps and ties
Medin Miniflow CPAP generators
For the paediatric population
Medin Sindi CPAP masks caps and ties
Fisher and Paykel Healthcare CPAP masks cannulas and caps
Miniflow CPAP generators from Medin
Fisher and Paykel Healthcare CPAP generators
Expected benefits
If it is shown that a reduction in the work of breathing is observed EAdi and usual clinical signs when HFNC flow rates are gradually increased and that this increase to flow rates of 3 to 5 Lkgmin is well tolerated and does not increase the risk of barotrauma HFNC ventilation at flow rates greater than 2 Lkgmin could be more widely proposed and accepted in the various units using it as it is unanimously accepted in terms of tolerance and comfort for the patient compared with CPAP
Recruitment procedures The patients eligible for this study will be those admitted to the neonatal and paediatric intensive care unit of the Clermont-Ferrand University Hospital by a doctor on the unit and who meet the various inclusion criteria for the study
An information note has been drawn up and will be presented and explained to the childs legal representatives by an investigating doctor during their usual care as well as to the child if his or her level of understanding is adequate within 2 hours of admission to the department The parents and the child will have a maximum of 1 hour to reflect and a maximum of 3 hours from admission to the ward between the time they are given the information and the time they sign the consent form
Legal representatives will then be asked to sign the written consent The childs inclusion in the DiaworkHFNC protocol will be recorded in the childs computerised medical record ICCA software
Objectives
Main objective To demonstrate the non-inferiority of high-flow nasal cannula flow rates compared with CPAP by analysis of diaphragmatic contraction EAdi Electrical activity of diaphragm in neonates over 34 weeks amenorrhoea SA up to children weighing less than 20 kg in respiratory failure
Secondary objectives
To compare different flows of HFNC 2 Lkgmin 3 Lkgmin 4 Lkgmin 5 Lkgmin with each other by analysing diaphragmatic contraction
Compare the clinical effectiveness of different flow rates of HFNC with CPAP in young children in respiratory distress
To compare the tolerability of different flow rates of HFNC with CPAP in the population of young children suffering from respiratory distress
To compare the incidence of minor digestive discomfort digestive bloating non-damaging skin lesions and major thoracic barotrauma damaging skin lesions side effects of different flow rates of HFNC with CPAP in young children in respiratory distress
To describe the choice of support and settings flow rates or PEEP levels made by the practitioners in charge of the child after the study period
To describe the epidemiological data from the paediatric intensive care and monitoring units and the neonatal intensive care unit
Type of study Randomised controlled cross-over single-centre non-inferiority trial of a medical device
Number of centres 1
Study design
Upon admission to the department if the eligibility criteria are met and the parents agree to the research a wash-out period will be performed under low-flow oxygen therapy at 1 Lmin to achieve SpO2 94 for 15 minutes
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 for up to 2 hours
The patients included will be their own controls and at the end of the first analysis according to the cross-over procedure the patients will change groups in order to perform the remaining analysis
A recourse procedure has been foreseen in case of failure of ventilatory support
Medical devices
Concerning HFNC ventilation
The nasal cannulas used are Optiflow cannulas Fisher and Paykel Laboratory which will be adapted to the size of each patients nostrils The following sizes are available
NICU patient Optiflow Junior 2
PICU patient Optiflow Junior 2 Optiflow
Concerning CPAP ventilation
For the neonatal population
Medin Sindi CPAP masks caps and ties
Medin Miniflow CPAP generators
For the paediatric population
Medin Sindi CPAP masks caps and ties
Fisher and Paykel Healthcare CPAP masks cannulas and caps
Miniflow CPAP generators from Medin
Fisher and Paykel Healthcare CPAP generators
Expected benefits
If it is shown that a reduction in the work of breathing is observed EAdi and usual clinical signs when HFNC flow rates are gradually increased and that this increase to flow rates of 3 to 5 Lkgmin is well tolerated and does not increase the risk of barotrauma HFNC ventilation at flow rates greater than 2 Lkgmin could be more widely proposed and accepted in the various units using it as it is unanimously accepted in terms of tolerance and comfort for the patient compared with CPAP
Recruitment procedures The patients eligible for this study will be those admitted to the neonatal and paediatric intensive care unit of the Clermont-Ferrand University Hospital by a doctor on the unit and who meet the various inclusion criteria for the study
An information note has been drawn up and will be presented and explained to the childs legal representatives by an investigating doctor during their usual care as well as to the child if his or her level of understanding is adequate within 2 hours of admission to the department The parents and the child will have a maximum of 1 hour to reflect and a maximum of 3 hours from admission to the ward between the time they are given the information and the time they sign the consent form
Legal representatives will then be asked to sign the written consent The childs inclusion in the DiaworkHFNC protocol will be recorded in the childs computerised medical record ICCA software
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None