Plain English Summary
Background and study aims
The diaphragm is a dome-shaped sheet of muscle that plays a vital role in breathing. Diaphragm dysfunction worsens outcomes in mechanically ventilated patients (breathing supported using a machine). However, the clinical impact of changes in diaphragm structure and function due to mechanical ventilation is unknown. In addition sick children who are provided with mechanical ventilation often have moderate or severe malnutrition together with deterioration of electrolyte levels and are at risk of refeeding syndrome (metabolic disturbances) and severe hypophosphatemia (low phosphate levels in the blood). The aim of this study is to find out whether diaphragm atrophy developing during mechanical ventilation leads to prolonged ventilation.
Who can participate?
Patients aged 1 month - 6 years who are mechanically ventilated
What does the study involve?
All participants receive the same treatment of underlying disease. Diaphragm thickness at the end of inspiration (breathing in) and diaphragmatic excursion (movement of the diaphragm during breathing) are measured on the 1st, 3rd, 5th and then every five days during mechanical ventilation by ultrasound. At the same time the levels of phosphorus, magnesium, calcium, potassium and sodium in the blood are measured.
What are the possible benefits and risks of participating?
The results of this study may improve the understanding of the role of diaphragm dysfunction during mechanical ventilation and its impact on malnutrition and electrolyte levels. There are no risks expected.
Where is the study run from?
Lviv Regional Clinical Children Hospital "OCHMATDYT" (Ukraine)
When is the study starting and how long is it expected to run for?
July 2018 to July 2019
Who is funding the study?
Danylo Halytskyy Lviv National Medical University (Ukraine)
Who is the main contact?
Dr Olha Filyk
doctor_555@ukr.net
Trial website
Contact information
Type
Public
Primary contact
Dr Olha Filyk
ORCID ID
http://orcid.org/0000-0003-3160-7617
Contact details
Lysenka str.
31
Lviv
79010
Ukraine
+380 (0)955107896
doctor_555@ukr.net
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1-2018
Study information
Scientific title
Diaphragm ultrasound and trends In electrolyte disorders and transthyretin level as a method to predict ventilation outcome in children: the prospective observational cohort study
Acronym
Study hypothesis
The duration of mechanical ventilation stay in the intensive care unit, and the frequency of complications in children depend on the degree of diaphragm atrophy.
Ethics approval
Ethics board of Danylo Halytskyy Lviv National Medical University, 31/01/2018, protocol №1-2018
Study design
Prospective observational cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Acute respiratory failure
Intervention
Diaphragm thickness (Tdi) at end of inspiration and diaphragmatic excursion will be measured on 1st, 3rd, 5th and than every five days during mechanical ventilation by ultrasound in children requiring invasive mechanical ventilation, and inspiratory effort will be assessed by thickening fraction. At the same time levels of phosphorus, magnesium, calcium, potassium and sodium in the patient's plasma will be evaluated.
Intervention type
Other
Phase
Drug names
Primary outcome measure
The time to liberation from ventilation; every day from baseline the trialists will check the possibility of weaning patients from mechanical ventilation (its mean decreasing of parameters during mechanical ventilation and extubation - both together) and then take into account duration of mechanical ventilation
Secondary outcome measures
1. Complications (reintubation, tracheostomy, prolonged ventilation, or death); the trialists will check for the presence of these adverse events every day from baseline, then on day 28 of hospitalisation and until patient is discharged from the hospital
2. Electrolyte levels (calcium, potassium, sodium measured using mixed venous blood test on acid-base balance; phosphorus and magnesium measured using biochemical venous blood test) and transthyretin level (blood samples analysed by ELISA); checked on 1st, 3rd, 5th, 7th, 9th and then every five days of mechanical ventilation until patient is weaned from mechanical ventilation and on 3rd and 5th days after weaning
Overall trial start date
09/07/2018
Overall trial end date
01/07/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Presence of informed consent from legal representatives of the child to take part in trial
2. Children aged 1 month - 6 years old
3. Acute respiratory failure with clinical data of excessive work of breathing, laboratory data of hypoxemia, hypercapnia or both, acidosis which leads to need to provide invasive mechanical ventilation
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
50
Participant exclusion criteria
1. Absence of informed consent from legal representatives of the child to take part in trial at any stage of this trial
2. Acute or chronic respiratory failure without need to provide invasive mechanical ventilation
3. Congenital heart diseases
4. Neuromyotonia according to results of electromyography
Recruitment start date
15/07/2018
Recruitment end date
01/06/2019
Locations
Countries of recruitment
Ukraine
Trial participating centre
Lviv Children Clinical Hospital "OCHMATDYT"
Lysenka str., 31
Lviv
79010
Ukraine
Sponsor information
Organisation
Danylo Halytskyy Lviv National Medical University
Sponsor details
Pekarska str.
69
Lviv
79010
Ukraine
+380 (0)322368470
kaf_anesthesiology_fpge@meduniv.lviv.ua
Sponsor type
University/education
Website
http://meduniv.lviv.ua/index.php?option=com_content&view=article&id=156&Itemid=232&lang=uk
Funders
Funder type
University/education
Funder name
Danylo Halytskyy Lviv National Medical University
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
After enrolling all 50 participants or ending the trial the trialists will prepare articles and disseminate trial results at conferences.
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Olha Filyk (doctor_555@ukr.net). Type of data will be patient cards and researcher tables which will be available on request 20 years after the research ends, the data will become available after end of the research. The consent from participants (their parents or legal representative of the patient) will be obtained before their enrolling into trial. Data will be anonymised in any published results of this investigation. This study has no ethical or legal restrictions.
Intention to publish date
01/08/2019
Participant level data
Available on request
Basic results (scientific)
Publication list