Comparing the use of gestational age or weight to estimate Neonatal Endotracheal tube Depth of Insertion (NEDI)
| ISRCTN | ISRCTN40879573 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40879573 |
| Secondary identifying numbers | N/A |
- Submission date
- 21/02/2012
- Registration date
- 12/06/2012
- Last edited
- 17/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
Newborn babies who have difficulty breathing after birth are often supported with a ventilator (respirator). Babies are ventilated through a plastic tube called an endotracheal tube (ETT) which is inserted into the trachea (windpipe) through the mouth. ETTs are marked each centimetre along their length from the tip so that it is known how far from the baby's lips the tube has been inserted. It is important that the tip of the ETT is correctly positioned in the trachea above the carina (the point where it divides to supply the left and right lung) so that support is given evenly to both lungs. Most doctors estimate how far they should insert the ETT using the baby's weight. Studies suggest that estimating the depth of insertion using their gestational age may be more accurate. We aim to determine which method is more accurate.
Who can participate?
Newborn babies who are having an ETT inserted for respiratory support in the Neonatal Intensive Care Unit (NICU).
What does the study involve?
Babies enrolled in this study will have the depth of insertion of the ETT estimated using either their gestational age or their birth weight.
What are the possible benefits and risks of participating?
One group may have a higher proportion of correctly placed ETTs. There are no more risks above those inherent in needing intubation and ventilation
Where is the study run from?
The National Maternity Hospital, Dublin, Ireland.
When is study starting and how long is it expected to run for?
The study started on 10/01/2012 and we estimate that it will run for 1 year.
Who is funding the study?
National Children's Research Centre (Ireland)
Who is the main contact?
Dr Colm ODonnell
Contact information
Scientific
The National Maternity Hospital
Holles Street
Dublin
2
Ireland
Study information
| Study design | Single centre randomised trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A randomised controlled trial comparing the use of gestational age or weight to estimate Neonatal Endotracheal tube Depth of Insertion (NEDI) |
| Study acronym | NEDI |
| Study objectives | Compared to using a newborn infant's weight, using the gestational age to estimate the appropriate depth of insertion of an oral endotracheal tube (ETT) will result in more correctly placed ETTs on chest X-ray (i.e. tip of ETT between upper border of the first thoracic vertebra, T1, and the lower border of the second thoracic vertebra, T2) |
| Ethics approval(s) | Ethics Committee at The National Maternity Hospital, Holles Street, Dublin, Ireland, 30/11/2011, ref: NEDI001 |
| Health condition(s) or problem(s) studied | Neonatal respiratory support |
| Intervention | Infants in both treatment arms will have an endotracheal tube placed via the mouth Infants randomised to WEIGHT will have the ETT secured at the lips at a depth determined by the formula Insertion Depth (cm) = 6 + (birth weight, kg) Infants randomised to GESTATIONAL AGE will have the ETT secured at the lips at a depth determined by the following table ETT length at lip (cm) Corrected gestation (weeks) 5.5 23 24 6.0 25 26 6.5 27 29 7.0 30 32 7.5 33 34 8.0 35 37 8.5 38 40 9.0 41 43 |
| Intervention type | Other |
| Primary outcome measure | Endotracheal tube (ETT) tip between the upper border of the 1st thoracic vertebra (T1) and the lower border of the second thoracic vertebra (T2) on chest X-ray |
| Secondary outcome measures | 1. Number of extubations before chest x-ray 2. Repositioning of ETT following chest x-ray 3. Unequal lung expansion on initial chest x-ray following intubation 4. Air leaks - pneumothorax, pneumomediastinum, pulmonary interstitial emphysema 5. Duration of ventilation 6. Oxygen therapy at 28 days 7. Oxygen at 36 weeks 8. Death before discharge from hospital |
| Overall study start date | 10/01/2012 |
| Completion date | 30/09/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 90 |
| Key inclusion criteria | Newly born infants [term (> or = 37 weeks' gestation) or preterm (< 37 weeks' gestation)] who are intubated in the neonatal intensive care unit |
| Key exclusion criteria | Infants with known upper airway (e.g. Pierre-Robin sequence) or lung (congenital diaphragmatic hernia) anomalies |
| Date of first enrolment | 10/01/2012 |
| Date of final enrolment | 30/09/2012 |
Locations
Countries of recruitment
- Ireland
Study participating centre
2
Ireland
Sponsor information
Hospital/treatment centre
c/o Dr Colm O'Donnell
Holles Street
Dublin
2
Ireland
"ROR" |
https://ror.org/03jcxa214 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | The datasets generated and analysed in this study are available upon request from Prof. Colm O’Donnell for a period of 5 years. Consent for sharing this data from the participants’ parent(s)/guardian(s) was not specifically sought at the time of study entry. The decision whether to share anonymised data will be made based on a description of the purpose for which the data is sought, and the types of planned analyses |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2015 | 16/01/2019 | Yes | No |
Editorial Notes
17/01/2019: IPD sharing statement added.
16/01/2019: Publication reference added.
