Pulmonary Aeration and Muscle Thickening Fraction: Association of Electrical Impedance Tomography and Ultrasound

NCT06376487 | Recruiting DMC

• 1 other identifier: 75202423.2.0000.0071
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bronchiolitis

Keywords

Pulmonary;; Ventilation;

Outcome Measures

Primary Outcomes (3)

• diaphragm thickening fraction

  to evaluate the diaphragm thickening fraction through ultrasound in infants with bronchiolitis using HFNC at 4 different flow rates, whether the diaphragm thickening fraction changes when the flow rate is changed

  during procedure

• abdominal muscle thickening fraction

  to evaluate the abdominal muscle thickening fraction through ultrasound in infants with bronchiolitis using HFNC at 4 different flow rates, whether the abdominal muscle thickening fraction changes when the flow rate is changed

  during procedure

• EELZ (end-expiration lung impedance)

  to evaluate the EELZ through electrical impedance tomography in infants with bronchiolitis using HFNC at 4 different flow rates, whether there is a change in the EELZ when the flow rate is changed

  during procedure

Study Arms (1)

flow rate sequence

EXPERIMENTAL

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.

Device: Flow rate evaluation

Interventions

Flow rate evaluation DEVICE

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.

flow rate sequence

Eligibility Criteria

• Age: Up to 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis of bronchiolitis
• Use of HFNC

You may not qualify if:

• Patients diagnosed with chronic diseases

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator
• Feculdade de Medicina da Universidade de Sao Paulo - Brasil: collaborator

Study Sites (1)

Hospital Israelita Albert Eisntein

São Paulo, 05653000, Brazil

RECRUITING

MeSH Terms

Conditions

Bronchiolitis; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Milena S Nascimento

  Hospital Israelita Albert Einstein

  PRINCIPAL INVESTIGATOR

• Celso M Rebello

  Hospital Israelita Albert Einstein

  STUDY CHAIR

Central Study Contacts

Milena S Nascimento

CONTACT

55 11 984520061; milena.nascimento@einstein.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Patient will not know the flow rate sequence used during the assessment
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A prospective clinical study to evaluated four different flow rate in infants with bronchiolitis using high flow nasal cannula

Study Record Dates

• First Submitted: February 16, 2024
• First Posted: April 19, 2024
• Study Start: May 1, 2024
• Primary Completion: July 31, 2025
• Study Completion: January 31, 2026
• Last Updated: April 19, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: The data will be shared after the inclusion of patients until the analysis of the results is completed
• Access Criteria: All data will be compiled and managed in the electronic data capture system "Research Electronic Data Capture" (REDCap) hosted on the servers of Hospital Israelite Albert Einstein (HIAE) (33). All data, when made available to the project team, will be made available in a de-identified form in order to protect the participant's identity and guarantee the integrity of the data.

Locations

BR (1)