Plain English Summary
Background and study aims
Many prematurely born infants, and a small number of those born at term, will require help with their breathing in the newborn period. A breathing tube connected to a ventilator (mechanical ventilation) can be life saving, but unfortunately it can be associated with long-term complications. The most common of these adverse outcomes is chronic lung disease, yet infants can also have neurological problems at follow up and may develop cerebral palsy. These complications are increased in infants who have suffered abnormalities in their carbon dioxide levels. Therefore, if we are to improve the outcomes of infants requiring breathing support in the newborn period, it is vital that we can appropriately and safely monitor these levels. By having a real time continuous reading of carbon dioxide we aim to be able to reduce the number of acute complications of respiratory support by allowing earlier detection of blocked or dislodged breathing tubes. We also aim to be able to reduce the number of invasive blood tests performed, which would normally be used to monitor carbon dioxide levels when continuous monitoring is not available. Finally by having continual monitoring of carbon dioxide levels available we aim to be able to regulate these values more closely to avoid levels that are either too high, or too low, the results of which may lead to the adverse outcomes mentioned above.
Who can participate?
Newborns requiring invasive mechanical ventilation within the newborn period
What does the study involve?
The research team will be approaching parents within the first day of admission to the neonatal unit to discuss the study and obtain informed written consent if parents wish for their baby to take part. The study will involve inserting a small CE marked device into the routine ventilator circuit so that the levels of carbon dioxide produced can be continuously monitored.
What are the possible benefits and risks of participating?
This device is aimed at improving newborn safety whilst infants are receiving life saving breathing support, therefore participants may benefit from the use of this device. As this study is non invasive and uses a CE trademarked device, there are no known risks to participants taking part.
Where is the study run from?
King’s College Hospital Neonatal Unit, London (UK)
When is the study starting and how long is it expected to run for?
October 2018 to August 2021 (updated 04/08/2020, previously: August 2020)
Who is funding the study?
1. The Charles Wolfson Charitable Trust (UK)
2. SLE Ltd (UK)
Who is the main contact?
Professor Anne Greenough
anne.greenough@kcl.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Prof Anne Greenough
ORCID ID
http://orcid.org/0000-0002-8672-5349
Contact details
4th Floor Golden Jubilee Wing
King's College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom
+44 (0)20 3299 3037
anne.greenough@kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
39771
Study information
Scientific title
Optimising mechanical ventilation in newborns using capnography
Acronym
Study hypothesis
1. Using end tidal capnography will allow earlier detection of acute complications in mechanically ventilated infants such as blocked or dislodged endotracheal tubes.
2. End tidal capnography will reduce the average daily frequency of invasive blood sampling and hence the associated complications related to blood transfusions.
3. Using side stream capnography to provide continuous monitoring will reduce the time spent with abnormal carbon dioxide levels and the development of serious complications such as bronchopulmonary dysplasia, intraventricular haemorrhage and periventricular leukomalacia.
4. Accurate calculation of anatomical and alveolar dead space in infants with various neonatal respiratory diseases using real time capnography will allow appropriate tidal volumes to be delivered in different respiratory conditions.
Ethics approval
Approved 14/11/2018, London-Camden & Kings Cross Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ; 0207 104 8018; nrescommittee.london-camdenandkingscross@nhs.net) ref: 18/LO/1602
Study design
Interventional non-randomised study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Mechanical ventilation in newborns
Intervention
A side stream capnograph will be integrated with the ventilator circuit for the whole time the infant is receiving invasive mechanical ventilation. In order to validate the side steam capnography against the gold standard mainstream capnography, the NM3 mainstream capnograph will be incorporated into the ventilator circuit for a 20 minute period.
Infants will have routine neonatal follow up as per the clinical team and no follow up specific to the research being carried out is required.
Intervention type
Device
Phase
Drug names
Primary outcome measure
Decrease in the complications of mechanical ventilation and decrease in the frequency of blood sampling in ventilated newborn infants.; Timepoint(s): .
The following are recorded throughout the period the infant is receiving invasive mechanical ventilation:
1. Frequency of complications of mechanical ventilation (pneumothorax, blocked or dislodged endotracheal tube, hypo or hypercarbia),
2. Frequency of routine blood gas sampling
These will be compared to historical controls who were invasively mechanically ventilated prior to the use of routine end tidal capnography monitoring.
Secondary outcome measures
1. Validation of side stream capnography with mainstream capnography and arterial carbon dioxide levels, ascertained by correlation of values in kPa during a twenty-minute validation period
2. Anatomical and alveolar dead space, calculated in mechanically ventilated infants with four neonatal respiratory conditions:
2.1. Respiratory distress syndrome
2.2. Evolving bronchopulmonary dysplasia
2.3. Meconium aspiration syndrome
2.4. Persistent pulmonary hypertension of the newborn
These will be calculated by analysing carbon dioxide waveforms using the Bohr/Enghoff equation once the infant is no longer receiving mechanical ventilation.
Overall trial start date
01/10/2018
Overall trial end date
31/08/2021
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Neonates
2. Invasively mechanically ventilated
3. Admitted to the neonatal intensive care unit
4. Written parental consent
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
Planned Sample Size: 200; UK Sample Size: 200
Participant exclusion criteria
1. Non ventilated infants
2. Infants on non-invasive respiratory support
Recruitment start date
28/11/2018
Recruitment end date
01/07/2021
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Neonatal Intensive Care Unit
4th Floor Golden Jubilee Wing
King's College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom
Sponsor information
Organisation
King's College Hospital
Sponsor details
R&D Manager
King's College Hospital NHS Foundation Trust
161 Denmark Hill
London
SE5 8EF
United Kingdom
+44 (0)20 3299 3841
Kch-tr.research@nhs.net
Sponsor type
Hospital/treatment centre
Website
Organisation
King's College London
Sponsor details
Director of Research Management and Directory of Administration
King's College London
Room 5.31
57 Waterloo Road
London
SE1 8WA
United Kingdom
+44 (0)207 848 3224
susan.dickson@kcl.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Charles Wolfson Charitable Trust
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
SLE LIMITED
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal. Results are intended to be published one year after the completion of the trial. Results will also be presented at national and international conferences.
IPD sharing statement:
The datasets analysed will be expected to be included in the subsequent results publication but full data sharing plans for the current study are not currently known and will be made available at a later date.
Intention to publish date
31/08/2022
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list