Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06376487
Status:
RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-02-16
Brief Title:
Pulmonary Aeration and Muscle Thickening Fraction Association of Electrical Impedance Tomography and Ultrasound
Sponsor:
Hospital Israelita Albert Einstein
Organization:
Hospital Israelita Albert Einstein
Study Overview
Official Title:
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
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 questions 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 20 literKg-1min-1 15 literKg-1min-1 10 literKg-1min-1 05 literKg-1min-1 At the end of the randomized order evaluation the infant will remain in the flow of 05 literKg-1min-1 for 5 minutes and then return to the flow of 20 literKg-1min-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
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 20 literKg-1min-1 15 literKg-1min-1 10 literKg-1min-1 05 literKg-1min-1 At the end of the randomized order evaluation the infant will remain in the flow of 05 literKg-1min-1 for 5 minutes and then return to the flow of 20 literKg-1min-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
Detailed Description:
OBJECTIVES Main Objective To evaluate in infants with respiratory failure secondary to bronchiolitis 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
Secondary Objectives
To evaluate whether there is a correlation between thickening fraction and respiratory distress score
To find values from the EIT data and the thickening fraction that can correlate with possible failure criteria for HFNC therapy
5 METHODS 51 Study Type and Location A prospective clinical study will be conducted in the Pediatric ICU of Hospital Israelite Albert Einstein from January 2024 to December 2025 52 Ethical Aspects This study will be submitted to the Ethics and Research Committee of the Hospital Israelite Albert Einstein The risk of participating in this research is considered minimal limited to the accidental loss of confidentiality of the data collected or to skin erythema at the site of application of the belt Only after signing the informed consent form will the patient be prepared for the beginning of monitoring Appendix 1 Protocol The tape will be installed around the chest before the start of the change in flow rates and monitoring with 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 20 literKg-1min-1 15 literKg-1min-1 10 literKg-1min-1 05 literKg-1min-1 At the end of the randomized order evaluation the infant will remain in the flow of 05 literKg-1min-1 for 5 minutes and then return to the flow of 20 literKg-1min-1 The EIT parameters ultrasound assessment and clinical variables will be collected at the end of the 5-minute stay in each lane
55 Randomization Randomization process The sequence of the flow values will be done using a tool software R 56 Clinical and demographic variables Demographic variables such as age sex Pediatric Index of Mortality Score PIM2 23 and viral screening will be collected when requested during routine hospitalization
Of the clinical variables respiratory rate RR will be assessed by counting the inspiratory cycles produced by EIT plethysmography in one minute Heart rate HR and peripheral oxygen saturation SpO2 will be obtained directly from the Infinity Delta multiparameter monitor Dräger Lubeck Germany Inspired oxygen fraction FiO2 The Respiratory and Oxygenation Index ROX index will also be calculated which is calculated by the ratio of SpO2FiO2 by RR
To evaluate respiratory distress the investigators will use the respiratory distress score
Electrical Impedance Tomography The recording of the electrical impedance variation over time is called plethysmogram and this provides information on the ventilation variation which is called Delta Z Z and has an excellent correlation with the volume variation assessed by computed tomography 25 and the minimum impedance ZMIN or EELZ end-expiration lung impedance which is the baseline of the plethysmogram and corresponds to the FRC 2627
The unit of measurement commonly used to quantify changes in impedance amplitude is arbitrary unit AUThe average of at least 5 sequential respiratory cycles for each patient in each flow range will be considered for evaluation considering the moment of greatest stability within the final minute of the flow rate to be evaluated Calculations to obtain delta Z were performed by subtracting the final moment of inspiration from the final moment of expiration The changes in EELZ EELZ will be compared to the average EELZ at a flow rate of 05 L-kg-1-min-1 reference flow rate Therefore by definition the average EELZ at the 05 L-kg-1-min-1 flow rate will be equal to zero To obtain clinically meaningful values instead of AU values the EELZ will be normalized by the corresponding Delta Z at the reference flow rate 28 With this transformation EELZ can be interpreted as changes in lung aeration measured in multiples of Delta Z tidal volumes For example if an infant has a mean Delta Z of 15 AU at flow rate of 05 L-kg-1-min-1 a EELZ of 30 AU at flow rate of 20 L-kg-1-min-1 will be shown as 2 an increase in lung volume twice the Delta Z at the reference flow rate
Evaluation by ultrasound Serial measurements of thickness and thickening fraction of the diaphragm and abdominal muscle rectus and oblique will be collected through ultrasound images by previously trained staff The images will be taken in the SonoSite M-Turbo device using an L25x 13-6 MHz linear transducer Heated water-based gel will be used for image acquisition
For the diaphragm thickness measurements the investigators used right hemidiaphragm with the linear transducer located between the anterior and middle axillary lines around the ninth intercostal space in the diaphragmatic apposition zone 2930 For the rectus abdominis thickness measurements the investigators used the linear transducer positioned 2 cm to the right and 2 cm above the umbilical scar The external oblique internal oblique and transverse muscles of the abdomen can be identified as three parallel layers usually best visualized on the anterior axillary line midway between the lower edge of the rib cage and the iliac crest 1516 The window will be obtained in B-moded and the measurement performed in M-mode For the measurement of the thickening fraction the investigators will use the formula Eins - Eex Ex x 100 where Eins thickness obtained at the end of inspiration and Eex thickness obtained at the end of expiration
Secondary Objectives
To evaluate whether there is a correlation between thickening fraction and respiratory distress score
To find values from the EIT data and the thickening fraction that can correlate with possible failure criteria for HFNC therapy
5 METHODS 51 Study Type and Location A prospective clinical study will be conducted in the Pediatric ICU of Hospital Israelite Albert Einstein from January 2024 to December 2025 52 Ethical Aspects This study will be submitted to the Ethics and Research Committee of the Hospital Israelite Albert Einstein The risk of participating in this research is considered minimal limited to the accidental loss of confidentiality of the data collected or to skin erythema at the site of application of the belt Only after signing the informed consent form will the patient be prepared for the beginning of monitoring Appendix 1 Protocol The tape will be installed around the chest before the start of the change in flow rates and monitoring with 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 20 literKg-1min-1 15 literKg-1min-1 10 literKg-1min-1 05 literKg-1min-1 At the end of the randomized order evaluation the infant will remain in the flow of 05 literKg-1min-1 for 5 minutes and then return to the flow of 20 literKg-1min-1 The EIT parameters ultrasound assessment and clinical variables will be collected at the end of the 5-minute stay in each lane
55 Randomization Randomization process The sequence of the flow values will be done using a tool software R 56 Clinical and demographic variables Demographic variables such as age sex Pediatric Index of Mortality Score PIM2 23 and viral screening will be collected when requested during routine hospitalization
Of the clinical variables respiratory rate RR will be assessed by counting the inspiratory cycles produced by EIT plethysmography in one minute Heart rate HR and peripheral oxygen saturation SpO2 will be obtained directly from the Infinity Delta multiparameter monitor Dräger Lubeck Germany Inspired oxygen fraction FiO2 The Respiratory and Oxygenation Index ROX index will also be calculated which is calculated by the ratio of SpO2FiO2 by RR
To evaluate respiratory distress the investigators will use the respiratory distress score
Electrical Impedance Tomography The recording of the electrical impedance variation over time is called plethysmogram and this provides information on the ventilation variation which is called Delta Z Z and has an excellent correlation with the volume variation assessed by computed tomography 25 and the minimum impedance ZMIN or EELZ end-expiration lung impedance which is the baseline of the plethysmogram and corresponds to the FRC 2627
The unit of measurement commonly used to quantify changes in impedance amplitude is arbitrary unit AUThe average of at least 5 sequential respiratory cycles for each patient in each flow range will be considered for evaluation considering the moment of greatest stability within the final minute of the flow rate to be evaluated Calculations to obtain delta Z were performed by subtracting the final moment of inspiration from the final moment of expiration The changes in EELZ EELZ will be compared to the average EELZ at a flow rate of 05 L-kg-1-min-1 reference flow rate Therefore by definition the average EELZ at the 05 L-kg-1-min-1 flow rate will be equal to zero To obtain clinically meaningful values instead of AU values the EELZ will be normalized by the corresponding Delta Z at the reference flow rate 28 With this transformation EELZ can be interpreted as changes in lung aeration measured in multiples of Delta Z tidal volumes For example if an infant has a mean Delta Z of 15 AU at flow rate of 05 L-kg-1-min-1 a EELZ of 30 AU at flow rate of 20 L-kg-1-min-1 will be shown as 2 an increase in lung volume twice the Delta Z at the reference flow rate
Evaluation by ultrasound Serial measurements of thickness and thickening fraction of the diaphragm and abdominal muscle rectus and oblique will be collected through ultrasound images by previously trained staff The images will be taken in the SonoSite M-Turbo device using an L25x 13-6 MHz linear transducer Heated water-based gel will be used for image acquisition
For the diaphragm thickness measurements the investigators used right hemidiaphragm with the linear transducer located between the anterior and middle axillary lines around the ninth intercostal space in the diaphragmatic apposition zone 2930 For the rectus abdominis thickness measurements the investigators used the linear transducer positioned 2 cm to the right and 2 cm above the umbilical scar The external oblique internal oblique and transverse muscles of the abdomen can be identified as three parallel layers usually best visualized on the anterior axillary line midway between the lower edge of the rib cage and the iliac crest 1516 The window will be obtained in B-moded and the measurement performed in M-mode For the measurement of the thickening fraction the investigators will use the formula Eins - Eex Ex x 100 where Eins thickness obtained at the end of inspiration and Eex thickness obtained at the end of expiration
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None