High Flow Nasal Cannulas in Children

NCT03689686 | Unknown

• 1 other identifier: ID247
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Failure

Keywords

Noninvasive ventilation

Outcome Measures

Primary Outcomes (1)

• Changes in respiratory work of breathing for each study trial

  Esophageal Pressure Time Product

  The last three minutes for each study trial

Study Arms (1)

Patients

EXPERIMENTAL

Fifteeen children with Acute Respiratory Failure admitted to a PICU, needing noninvasive respiratory support

Device: Noninvasive Respiratory Support

Interventions

Noninvasive Respiratory Support DEVICE

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

Patients

Eligibility Criteria

• Age: 15 Days - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

Giovanna Chidini

Cernusco sul Naviglio, Milan, 20063, Italy

RECRUITING

Related Publications (5)

• Chidini G, Piastra M, Marchesi T, De Luca D, Napolitano L, Salvo I, Wolfler A, Pelosi P, Damasco M, Conti G, Calderini E. Continuous positive airway pressure with helmet versus mask in infants with bronchiolitis: an RCT. Pediatrics. 2015 Apr;135(4):e868-75. doi: 10.1542/peds.2014-1142. Epub 2015 Mar 16.

  PMID: 25780074 RESULT

• Chidini G, Calderini E, Cesana BM, Gandini C, Prandi E, Pelosi P. Noninvasive continuous positive airway pressure in acute respiratory failure: helmet versus facial mask. Pediatrics. 2010 Aug;126(2):e330-6. doi: 10.1542/peds.2009-3357. Epub 2010 Jul 26.

  PMID: 20660548 RESULT

• Maggiore SM, Idone FA, Vaschetto R, Festa R, Cataldo A, Antonicelli F, Montini L, De Gaetano A, Navalesi P, Antonelli M. Nasal high-flow versus Venturi mask oxygen therapy after extubation. Effects on oxygenation, comfort, and clinical outcome. Am J Respir Crit Care Med. 2014 Aug 1;190(3):282-8. doi: 10.1164/rccm.201402-0364OC.

  PMID: 25003980 RESULT

• Mauri T, Turrini C, Eronia N, Grasselli G, Volta CA, Bellani G, Pesenti A. Physiologic Effects of High-Flow Nasal Cannula in Acute Hypoxemic Respiratory Failure. Am J Respir Crit Care Med. 2017 May 1;195(9):1207-1215. doi: 10.1164/rccm.201605-0916OC.

  PMID: 27997805 RESULT

• 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

Study Officials

• Giovanna Chidini, MD

  Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giovanna Chidini, MD

CONTACT

+39-2-55032242; giovanna.chidini@policlinico.mi.it

Edoardo Calderini, MD

CONTACT

+39-2-55032242; edoardo.calderini@policlinico.mi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2018
• First Posted: September 28, 2018
• Study Start: August 1, 2018
• Primary Completion: September 22, 2018
• Study Completion: September 22, 2018
• Last Updated: September 28, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)