High Flow Nasal Cannulas in Children (HFNC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03689686|
Recruitment Status : Unknown
Verified September 2018 by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico.
Recruitment status was: Recruiting
First Posted : September 28, 2018
Last Update Posted : September 28, 2018
Non-invasive Continuous Positive Airway Pressure (nCPAP) is widely recognized as an efficient respiratory support in infants with mild to moderate Acute Hypoxemic Respiratory Failure (AHRF).
Its application results in alveolar recruitment, inflation of collapsed alveoli, and reduction of intrapulmonary shunt. nCPAP is traditionally delivered with nasal prongs, nasal/facial mask. CPAP by helmet was introduced more recently in the clinical practice.
The helmet circuit was described in details in previously published studies. From a physiological point of view the helmet circuit could be considered the best system to deliver CPAP because of the following: 1) it is characterized by the lowest amount of leaks around the interface and mouth opening 2) airways are free from potentially obstructing devices (cannula) thus the resistance is minimized and 3) theoretically the pressure is more stable minimizing the leaks 4) it is comfortable and usually sedation is not needed.
High Flow Nasal Cannula (HFNC) is increasing in use both in adults and pediatric population. HFNC could result in several clinical benefits by reducing inspiratory effort and work of breathing, increasing end-expiratory volume and CO2 wash-out for upper airways and creating a CPAP effects of 2-3 cmH2Oin the upper airways. This CPAP effect combined with an increase in CO2 wash-out and optimal airways humidification could decrease the respiratory work of breathing and improve gas exchange. However little is known about the optimal flow rate setting to improve the respiratory mechanics and gas exchange. Recent studies have reported that HFNC in nonintubated children improves oxygenation, reduces the respiratory drive and prevent reintubation in high patient risk. However all these physiological effects during HFNC therapy are only speculative.
To address the question on the more efficient devices to support the child in the early phase of mild to moderate AHRF, the Authors designed a physiological randomized crossover study aimed at measuring the physiological effects of HFNC 2 and 3 l/Kg and helmet CPAP on the work of breathing (estimated by the esophageal Pressure Time Product, PTPes) in pediatric AHRF.
|Condition or disease||Intervention/treatment||Phase|
|Acute Respiratory Failure||Device: Noninvasive Respiratory Support||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Physiological Effects of High Flow Nasal Cannulas Oxygen Therapy vs Continuous Positive Airway Pressure in Pediatric Acute Respiratory Failure|
|Actual Study Start Date :||August 1, 2018|
|Actual Primary Completion Date :||September 22, 2018|
|Estimated Study Completion Date :||September 22, 2018|
Fifteeen children with Acute Respiratory Failure admitted to a PICU, needing noninvasive respiratory support
Device: Noninvasive Respiratory Support
Physiological crossover prospective study comparing four study trials (20 mins) delivered in computer generated random order:
- Changes in respiratory work of breathing for each study trial [ Time Frame: The last three minutes for each study trial ]Esophageal Pressure Time Product
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03689686
|Contact: Giovanna Chidini, MDemail@example.com|
|Contact: Edoardo Calderini, MDfirstname.lastname@example.org|
|Cernusco Sul Naviglio, Milan, Italy, 20063|
|Contact: Giovanna Chidini, MD +39-3463272082 email@example.com|
|Principal Investigator: Giovanna Chidini, MD|
|Principal Investigator:||Giovanna Chidini, MD||Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico|