Status:
UNKNOWN
Asynchronies in Pediatric Noninvasive Ventilation
Lead Sponsor:
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Conditions:
Pediatric Respiratory Diseases
Eligibility:
All Genders
1-4 years
Phase:
NA
Brief Summary
The term ''Non-invasive ventilation'' (NIV) refers to various methods of respiratory assistance, in the absence of an indwelling endotracheal tube. In recent years, the use of NIV has increased for th...
Detailed Description
After having obtained the signed informed consent from the parents of the patient, a 6 Fr pediatric esophageal balloon-catheter will be placed through a nostril in the distal third of the esophagus. ...
Eligibility Criteria
Inclusion
- Patients with acute hypoxic (SpO2/FIO2 ratio \< 315) or hypercapnic (PvCO2 \> 52 mmHg and venous pH \<7.28) respiratory failure in which non-invasive respiratory support is clinically indicated
- Age: \> 28 days and \< 4 years
- Patients whose parents provided signed informed consent
Exclusion
- Age \> 4 years or \< 28 days
- Patients whose parents did not provide signed informed consent
- Clinical contraindications to non-invasive ventilation
- Clinical contraindication to the placement of an esophageal balloon
Key Trial Info
Start Date :
September 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 15 2021
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04017780
Start Date
September 15 2019
End Date
July 15 2021
Last Update
November 27 2019
Active Locations (1)
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1
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Milan, Italy, 20122