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Trial record 5 of 10 for:    25003980 [PUBMED-IDS]

High Flow Nasal Cannulas in Children (HFNC)

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ClinicalTrials.gov Identifier: NCT03689686
Recruitment Status : Recruiting
First Posted : September 28, 2018
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Brief Summary:

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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Experimental: Patients
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:

  1. Standard Oxygen therapy with mask
  2. HFNC flow 2l/Kg
  3. HFNC flow 3l/Kg
  4. Helmet CPAP




Primary Outcome Measures :
  1. Changes in respiratory work of breathing for each study trial [ Time Frame: The last three minutes for each study trial ]
    Esophageal Pressure Time Product



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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

P/F<300 with oxygen mask (FiO2=0.4) for 15 minutes plus two of the followings:

  • Respiratory Rate (RR)>2SD according to age
  • Active contraction of respiratory muscles
  • Paradoxical abdominal motion

Exclusion Criteria:

  • Emergency need for intubation
  • Glasgow Coma Scale <12
  • Hypercapnia with pH <7.25
  • Cough reflex impairment
  • Upper-airway obstruction
  • Facial/gastric surgery
  • Recurrent apnoeas
  • Hemodynamic instability (need for vasopressor or inotropes)
  • Pneumothorax on lung echo or chest x ray
  • esophageal surgery.

Information from the National Library of Medicine

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


Contacts
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Contact: Giovanna Chidini, MD +39-2-55032242 giovanna.chidini@policlinico.mi.it
Contact: Edoardo Calderini, MD +39-2-55032242 edoardo.calderini@policlinico.mi.it

Locations
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Italy
Giovanna Chidini Recruiting
Cernusco Sul Naviglio, Milan, Italy, 20063
Contact: Giovanna Chidini, MD    +39-3463272082    giovanna.chidini@policlinico.mi.it   
Principal Investigator: Giovanna Chidini, MD         
Sponsors and Collaborators
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Investigators
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Principal Investigator: Giovanna Chidini, MD Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Publications of Results:

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Responsible Party: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
ClinicalTrials.gov Identifier: NCT03689686     History of Changes
Other Study ID Numbers: ID247
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico:
Noninvasive ventilation

Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiratory Distress Syndrome, Adult
Respiration Disorders
Respiratory Tract Diseases
Lung Diseases