Diaphragm ultrasound and trends In electrolyte disorders and transthyretin level as a method to predict ventilation outcome in children: the prospective observational cohort study
| ISRCTN | ISRCTN84734652 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84734652 |
| Secondary identifying numbers | 1-2018 |
- Submission date
- 10/07/2018
- Registration date
- 12/07/2018
- Last edited
- 12/03/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
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
Contact information
Public
Lysenka str., 31
Lviv
79010
Ukraine
 ORCID ID |
0000-0003-3160-7617 |
|---|---|
| Phone | +380 (0)955107896 |
| doctor_555@ukr.net |
Study information
| Study design | Prospective observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| 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 |
| Study objectives | 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(s) | Ethics board of Danylo Halytskyy Lviv National Medical University, 31/01/2018, protocol №1-2018 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 09/07/2018 |
| Completion date | 01/07/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 1 Month |
| Upper age limit | 6 Years |
| Sex | Both |
| Target number of participants | 50 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 15/07/2018 |
| Date of final enrolment | 01/06/2019 |
Locations
Countries of recruitment
- Ukraine
Study participating centre
Lviv
79010
Ukraine
Sponsor information
University/education
Pekarska str., 69
Lviv
79010
Ukraine
| Phone | +380 (0)322368470 |
|---|---|
| kaf_anesthesiology_fpge@meduniv.lviv.ua | |
| Website | http://meduniv.lviv.ua/index.php?option=com_content&view=article&id=156&Itemid=232&lang=uk |
"ROR" |
https://ror.org/0027cag10 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 01/08/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 plan | 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. |
Editorial Notes
12/03/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 15/12/2018 to 01/06/2019.
2. The overall trial end date was changed from 15/01/2019 to 01/07/2019.
3. The intention to publish date was changed from 15/01/2019 to 01/08/2019.
