Congenital Heart DiseaseNCT04311918
The Effect of Fluids Flushed in Pediatric Cardiac Catheterization Procedures on Lung Ultrasound Score
An observational study of Congenital Heart Disease, run by Cairo University at 1 site in Egypt.
Trial summary
Therapeutic catheterizations substituted many traditional surgical procedures with the advance of transcatheter techniques. Pediatric patients are more liable to fluid overload due to their smaller weights compared to adults and the risk increases in pediatrics with congenital heart diseases due to lower tolerability… Read more about this study
- Who is it for?
- Ages 1 month to 6 years
- Conditions the study is for
- Congenital Heart Disease
- How many people
- 43 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2020to 15 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: Children from 1 month to 6 years undergoing cardiac catheterization procedures.. This study will be conducted at Abo El Reesh Paediatric Hospital, Faculty of Medicine
Who may be able to join
- Pediatric patients undergoing diagnostic cardiac catheterization procedures.
Who cannot join
- Age <1 month and >6 years.
- Preoperative mechanical ventilation.
- Heart failure
- Patients with oligemic lung diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Fluids Flushed in Pediatric Cardiac Catheterization Procedures on Lung Ultrasound Score: A Prospective Observational Study
Therapeutic catheterizations substituted many traditional surgical procedures with the advance of transcatheter techniques.
Pediatric patients are more liable to fluid overload due to their smaller weights compared to adults and the risk increases in pediatrics with congenital heart diseases due to lower tolerability and reserve capacity and some of them may already have a degree of heart failure. Fluid overload increases the incidence of morbidity and mortality in such patients.
The aim of our study is to observe the amount of fluids needed for flushing during pediatric cardiac catheterization (in ml/kg) and asses its effect on total lung water and PaO2/FiO2, aiming to develop a useful protocol for the amount of fluids used.
Read the detailed description
.Objectives: The objective of this study is to assess lung water by comparing the calculated values of lung score by ultrasound, PaO2/FiO2 ratio and PaCO2 obtained from arterial blood gases' samples before and after the procedures.
. Study Design:
- A prospective observational study. Study Method
- Population of study \& disease condition Children from 1 month to 6 years undergoing cardiac catheterization procedures..
- Study setting:
This study will be conducted at Abo El Reesh Paediatric Hospital, Faculty of Medicine, Cairo University.
- Methodology in details: General anesthesia After interviewing and taking proper history from the parents, examining the patients, checking all routine investigations, informed consent will be taken after discussion with them.
Standard monitoris will be applied to all patients (electrocardiography, pulse oximetry, end-tidal Carbon dioxide CO2, non-invasive arterial blood pressure). All patients will be induced with inhalational induction using 4% sevoflurane in 100% oxygen followed by placement of a peripheral intravenous cannula. Oral endotracheal intubation will be facilitated by IV administration of fentanyl (1-2mic/kg) and atracurium (0.5mg/kg).
Mechanical ventilation will be maintained with an inspired oxygen fraction (FiO2) of 50%, a positive end expiratory pressure (PEEP) of 5 cmH2O, I:E ratio of 1:2 and a peak inspiratory pressure (PIP) will be set to deliver a tidal volume of 5-8 ml/kg and respiratory rate from 15 to 35 cycle per minute according to the end tidal carbon dioxide CO2.
After maintenance of anesthesia and before the procedure lung ultrasound examination will be performed using curved transducer with low frequency (2-5MHz) and will be assessed for the presence of B lines. Arterial blood gases will be aspirated. After the end of the procedure and before awakening the patient both arterial blood gases and lung ultrasound examination will be repeated provided that no complications occurred such as spell or hypertensive crisis.
Maintenance requirements of intravenous fluids will be given by crystalloid solution (lactated ringer) calculated by the "4:2:1 rule": 4 ml/kg/h for the first 10 kg of weight, 2 ml/kg/h for the second 10 kg, and 1 ml/kg/h for each remaining kilograms, in addition preoperative fluid deficits will be replaced calculated by multiplying maintenance requirement per hour by number of hours infant has not received oral or intravenous fluids prior to surgery in aliquots of 50% in the first hour and 25% in second and third hours.
The operators will insert intra-vascular sheathes and catheters that will frequently need to be flushed with heparinized solutions to keep them patent. The amount of the infused solutions will be calculated. This amount will be correlated to the lung ultrasound score.
Lung ultrasound The lung ultrasound score (LUS) is obtained by scanning 12-rib interspaces where each hemithorax divided into 6 areas. Each scanning site yields a score denoting the extent of interstitial pulmonary oedema.
Zero is defined as a complete absence of B-lines in the investigated area. When B-lines are few in the scanning site, they can be easily counted. When they are more numerous, they tend to be confluent and it is less easy to clearly enumerate them. To obtain a semi quantification of the sign, we consider the percentage of scanning site obtained by B-lines (i.e, the percentage of the white screen compared to the black screen below the pleural line) and then divided by 10 (i.e, 30% corresponds to about 3 B-lines, 70% corresponds to about 7 B-lines , and so on). This yields lung score in each site.
Scoring system of lung ultrasound:
Four ultrasound aeration patterns were defined as:
Normal aeration (N): Line sliding sign associated with respiratory movement. Moderate loss of lung aeration (B1 lines) : A clear number of multiple visible B-lines with horizontal spacing between adjacent B lines ≤ 7 mm.
Severe loss of lung aeration (B2 lines): Multiple B lines fused together that were difficult to count with horizontal spacing between adjacent B lines ≤ 3 mm.
White lung,pulmonary consolidation (C): Hyperechoic lung tissue, accompanied by dynamic air bronchogram.
LUS will be determined based on four lung ultrasonographs: N = 0, B1 = 1, B2 = 2 , and C = 3. All patients will undergo a lung ultrasound, and each of the 12 lung areas will be examined. The final LUS of the patient will be the sum of each regional ultrasound score (ranging from 0 to 36).
- Intervention:
Diagnostic intervention: After maintenance of anesthesia and before the procedure lung ultrasound examination will be performed and will be assessed for the presence of B lines. Arterial blood gases will be aspirated. After the end of the procedure and before awakening the patient both arterial blood gases and lung ultrasound examination will be repeated provided that no complications occurred such as spell or hypertensive crisis.
- Potential risks: No additional risks to the study and any risk is related to the surgical procedure itself.
Statistical analysis The Statistical Package of Social Science software program (SPSS), version 21 (Chicago, USA) will be used for all statistical comparisons. Continuous quantitative normally distributed data will be expressed as means and standard deviations (SD), while non-normally distributed data will be expressed as median and range. Qualitative nominal data will be expressed by percentage.
After testing for normality, continuous variables will be compared using t-test or Mann-Whitney U test as appropriate. Categorical variables will be compared using Chi- squared test or Fisher's exact test as appropriate. Changes over time will be compared using ANOVA for repeated measures with Bonferroni correction. Correlation between amount of fluids and lung score will be conducted by pearson's or spearman's methods according to the normality of data. A p-value <0.05 will be considered statistically significant.
- Conditions
- Congenital Heart Disease
- Keywords
- congenital - cardiac catheterization
- Medical subject headings
- Heart Defects, Congenital
What is being measured
The primary outcome is the main question the study is designed to answer.
Change between lung ultrasound score before and after fluids flushed
heparinized fluids are flushed throughout catheterization through venous and arterial sheathes , ultrasound score will be measured before and after the flushing
Measured: at the start of the procedure of cardiac catherization and immediately after the end of the procedure
Secondary outcomes (2)
. Change between PaO2/FiO2 ratio
change in ratio between arterial Oxygen tension and Fraction of inspired Oxygen
Measured: immediately before and immediately after the procedure.
Correlation between lung score and PaO2/FiO2 ratio
statistically measuring if there is a relation between lung ultrasound score and PaO2/FiO2 ratio
Measured: immediately before and immediately after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start1 Mar 2020
- Primary completion15 Oct 2020 (estimated)
- Study completion15 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Madkour, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04311918
- Sponsor's protocol ID
- MD-20-2020
- Status last verified
- Mar 2020
- First submitted
- 11 Mar 2020
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Fluids Flushed in Pediatric Cardiac Catheterization Procedures on Lung Ultrasound Score: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04311918
- Acronym / sponsor ID
- MD-20-2020
- Conditions
- Congenital Heart Disease
- Keywords
- congenital - cardiac catheterization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 15 Oct 2020 (estimated)
- Study completion
- 15 Mar 2021 (estimated)
- First posted
- 17 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Therapeutic catheterizations substituted many traditional surgical procedures with the advance of transcatheter techniques.
Pediatric patients are more liable to fluid overload due to their smaller weights compared to adults and the risk increases in pediatrics with congenital heart diseases due to lower tolerability and reserve capacity and some of them may already have a degree of heart failure. Fluid overload increases the incidence of morbidity and mortality in such patients.
The aim of our study is to observe the amount of fluids needed for flushing during pediatric cardiac catheterization (in ml/kg) and asses its effect on total lung water and PaO2/FiO2, aiming to develop a useful protocol for the amount of fluids used.
Detailed description
.Objectives: The objective of this study is to assess lung water by comparing the calculated values of lung score by ultrasound, PaO2/FiO2 ratio and PaCO2 obtained from arterial blood gases' samples before and after the procedures.
. Study Design:
- A prospective observational study. Study Method
- Population of study \& disease condition Children from 1 month to 6 years undergoing cardiac catheterization procedures..
- Study setting:
This study will be conducted at Abo El Reesh Paediatric Hospital, Faculty of Medicine, Cairo University.
- Methodology in details: General anesthesia After interviewing and taking proper history from the parents, examining the patients, checking all routine investigations, informed consent will be taken after discussion with them.
Standard monitoris will be applied to all patients (electrocardiography, pulse oximetry, end-tidal Carbon dioxide CO2, non-invasive arterial blood pressure). All patients will be induced with inhalational induction using 4% sevoflurane in 100% oxygen followed by placement of a peripheral intravenous cannula. Oral endotracheal intubation will be facilitated by IV administration of fentanyl (1-2mic/kg) and atracurium (0.5mg/kg).
Mechanical ventilation will be maintained with an inspired oxygen fraction (FiO2) of 50%, a positive end expiratory pressure (PEEP) of 5 cmH2O, I:E ratio of 1:2 and a peak inspiratory pressure (PIP) will be set to deliver a tidal volume of 5-8 ml/kg and respiratory rate from 15 to 35 cycle per minute according to the end tidal carbon dioxide CO2.
After maintenance of anesthesia and before the procedure lung ultrasound examination will be performed using curved transducer with low frequency (2-5MHz) and will be assessed for the presence of B lines. Arterial blood gases will be aspirated. After the end of the procedure and before awakening the patient both arterial blood gases and lung ultrasound examination will be repeated provided that no complications occurred such as spell or hypertensive crisis.
Maintenance requirements of intravenous fluids will be given by crystalloid solution (lactated ringer) calculated by the "4:2:1 rule": 4 ml/kg/h for the first 10 kg of weight, 2 ml/kg/h for the second 10 kg, and 1 ml/kg/h for each remaining kilograms, in addition preoperative fluid deficits will be replaced calculated by multiplying maintenance requirement per hour by number of hours infant has not received oral or intravenous fluids prior to surgery in aliquots of 50% in the first hour and 25% in second and third hours.
The operators will insert intra-vascular sheathes and catheters that will frequently need to be flushed with heparinized solutions to keep them patent. The amount of the infused solutions will be calculated. This amount will be correlated to the lung ultrasound score.
Lung ultrasound The lung ultrasound score (LUS) is obtained by scanning 12-rib interspaces where each hemithorax divided into 6 areas. Each scanning site yields a score denoting the extent of interstitial pulmonary oedema.
Zero is defined as a complete absence of B-lines in the investigated area. When B-lines are few in the scanning site, they can be easily counted. When they are more numerous, they tend to be confluent and it is less easy to clearly enumerate them. To obtain a semi quantification of the sign, we consider the percentage of scanning site obtained by B-lines (i.e, the percentage of the white screen compared to the black screen below the pleural line) and then divided by 10 (i.e, 30% corresponds to about 3 B-lines, 70% corresponds to about 7 B-lines , and so on). This yields lung score in each site.
Scoring system of lung ultrasound:
Four ultrasound aeration patterns were defined as:
Normal aeration (N): Line sliding sign associated with respiratory movement. Moderate loss of lung aeration (B1 lines) : A clear number of multiple visible B-lines with horizontal spacing between adjacent B lines ≤ 7 mm.
Severe loss of lung aeration (B2 lines): Multiple B lines fused together that were difficult to count with horizontal spacing between adjacent B lines ≤ 3 mm.
White lung,pulmonary consolidation (C): Hyperechoic lung tissue, accompanied by dynamic air bronchogram.
LUS will be determined based on four lung ultrasonographs: N = 0, B1 = 1, B2 = 2 , and C = 3. All patients will undergo a lung ultrasound, and each of the 12 lung areas will be examined. The final LUS of the patient will be the sum of each regional ultrasound score (ranging from 0 to 36).
- Intervention:
Diagnostic intervention: After maintenance of anesthesia and before the procedure lung ultrasound examination will be performed and will be assessed for the presence of B lines. Arterial blood gases will be aspirated. After the end of the procedure and before awakening the patient both arterial blood gases and lung ultrasound examination will be repeated provided that no complications occurred such as spell or hypertensive crisis.
- Potential risks: No additional risks to the study and any risk is related to the surgical procedure itself.
Statistical analysis The Statistical Package of Social Science software program (SPSS), version 21 (Chicago, USA) will be used for all statistical comparisons. Continuous quantitative normally distributed data will be expressed as means and standard deviations (SD), while non-normally distributed data will be expressed as median and range. Qualitative nominal data will be expressed by percentage.
After testing for normality, continuous variables will be compared using t-test or Mann-Whitney U test as appropriate. Categorical variables will be compared using Chi- squared test or Fisher's exact test as appropriate. Changes over time will be compared using ANOVA for repeated measures with Bonferroni correction. Correlation between amount of fluids and lung score will be conducted by pearson's or spearman's methods according to the normality of data. A p-value <0.05 will be considered statistically significant.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children from 1 month to 6 years undergoing cardiac catheterization procedures.. This study will be conducted at Abo El Reesh Paediatric Hospital, Faculty of Medicine
Key inclusion criteria (1 listed)
- Pediatric patients undergoing diagnostic cardiac catheterization procedures.
Key exclusion criteria (4 listed)
- Age <1 month and >6 years.
- Preoperative mechanical ventilation.
- Heart failure
- Patients with oligemic lung diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change between lung ultrasound score before and after fluids flushed
Time frame: at the start of the procedure of cardiac catherization and immediately after the end of the procedure
heparinized fluids are flushed throughout catheterization through venous and arterial sheathes , ultrasound score will be measured before and after the flushing
2 secondary outcomes
. Change between PaO2/FiO2 ratio
Time frame: immediately before and immediately after the procedure.
Correlation between lung score and PaO2/FiO2 ratio
Time frame: immediately before and immediately after the procedure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change between lung ultrasound score before and after fluids flushed (time frame: at the start of the procedure of cardiac catherization and immediately after the end of the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.