Evaluation of Pulmonary Aeration and Muscle Thickening Fraction in Infants With Bronchiolitis Using a High-flow Nasal Cannula: Association of Electrical Impedance Tomography and Ultrasound

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this prospective clinical study is to evaluate the effect of different High Flow Nasal Cannula (HFNC) flow rates on diaphragm, rectoabdominal, and oblique thickening fraction, and to determine whether this effect depends on the action of HFNC flow rates on Functional Residual Capacity (FRC) in Infants under 2 years of age with a diagnosis of bronchiolitis and indication for use of HFNC. The main question\[s\] it aims to answer are: * If the thickening fraction of the abdominal muscle and diaphragm will change at the different flow rates evaluated * If the end-expiration lung impedance (EELZ) will change at the different flow rates evaluated The belt will be installed around the chest before the start of the change in flow rates and monitoring with Electrical Impedance Tomography (EIT) will be initiated. Patients will be positioned in dorsal decubitus elevated 10 to 20 degrees and monitoring will be performed continuously during all flow rate variations and also during the ultrasound performance. Four different randomized flow rates will be used for evaluation: 2.0 liter.Kg-1.min-1, 1.5 liter.Kg-1.min-1, 1.0 liter.Kg-1.min-1, 0.5 liter.Kg-1.min-1. At the end of the randomized order evaluation the infant will remain in the flow of 0.5 liter.Kg-1.min-1 for 5 minutes and then return to the flow of 2.0 liter.Kg-1.min-1. The EIT parameters, ultrasound assessment, and clinical variables will be collected at the end of the 5-minute stay in each lane. The randomization of the order of application of the phases will be carried out in blocks, so that the homogeneity of the sequences is maintained even if the collection is interrupted before reaching the total number of individuals. The blocks will be of size two and four and the test and production lists will be generated with the help of the R packages.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 2
Healthy Volunteers: f
View:

• Diagnosis of bronchiolitis

• Use of HFNC

Locations
Other Locations
Brazil
Hospital Israelita Albert Eisntein
RECRUITING
São Paulo
Contact Information
Primary
Milena S Nascimento
milena.nascimento@einstein.br
55 11 984520061
Time Frame
Start Date: 2024-05-01
Estimated Completion Date: 2026-01-31
Participants
Target number of participants: 82
Treatments
Experimental: flow rate sequence
Four different randomized flow rates will be used for evaluation: 2.0 liter.Kg-1.min-1, 1.5 liter.Kg-1.min-1, 1.0 liter.Kg-1.min-1, 0.5 liter.Kg-1.min-1. At the end of the randomized order evaluation the infant will remain in the flow of 0.5 liter.Kg-1.min-1 for 5 minutes and then return to the flow of 2.0 liter.Kg-1.min-1. The EIT parameters, ultrasound assessment, and clinical variables will be collected at the end of the 5-minute stay in each lane.
Related Therapeutic Areas
Sponsors
Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo, Feculdade de Medicina da Universidade de Sao Paulo - Brasil
Leads: Hospital Israelita Albert Einstein

This content was sourced from clinicaltrials.gov