Condition category
Respiratory
Date applied
10/07/2018
Date assigned
12/07/2018
Last edited
12/07/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 October 2018

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

15/01/2019

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

15/12/2018

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

15/01/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes