Estimating neonatal oral endotracheal tube depth of insertion using weight or suprasternal palpation of the tip
| ISRCTN | ISRCTN13570106 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13570106 |
| Secondary identifying numbers | NEDI31 |
- Submission date
- 15/11/2016
- Registration date
- 01/12/2016
- Last edited
- 09/06/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Neonatal Diseases
Plain English Summary
Background and study aims
Many newborn babies have breathing difficulties after birth and need help. Some infants require a plastic tube (called an endotracheal tube) to be inserted into their windpipe (trachea) that is then connected to a breathing machine (ventilator). Endotracheal tubes are inserted through the baby’s mouth into their windpipe. It is important that the tip of the tube is in the correct position so that both lungs are ventilated equally. When doctors are inserting the tube, they usually estimate how far the tube needs to be inserted by using the birth weight of the baby. After the tube is inserted, it is secured and a chest x-ray is done to show the tube position. When the distance to which the tube is inserted is estimated using the baby’s weight it is in the correct position about 50% of the time. The aim of this study is to find out whether using a different technique to judge the depth of insertion, by gently pressing on the V-shaped notch above the breastbone and feeling the tube as it passes under one’s finger, would lead to more tubes being better placed.
Who can participate?
Newborn babies who are intubated in the neonatal intensive care unit (NICU)
What does the study involve?
Babies are randomly allocated to have the depth to which the endotracheal tube is inserted estimated either by feeling the tip of the tube or by using their birth weight. All babies have the endotracheal tube position checked with a chest X-ray. Babies do not undergo any extra tests for this study.
What are the possible benefits and risks of participating?
One method of estimating the insertion depth may be better, but this will not be known until the study has finished and the results have been analysed. There are no known extra risks of taking part in the study.
Where is the study run from?
National Maternity Hospital (Ireland)
When is the study starting and how long is it expected to run for?
December 2016 to June 2019
Who is funding the study?
National Maternity Hospital (Ireland)
Who is the main contact?
1. Prof. Colm O'Donnell
2. Dr Madeleine Murphy
Contact information
Scientific
Neonatal Unit
National Maternity Hospital
Holles Street
Dublin
D02 YH21
Ireland
Study information
| Study design | Single-centre unmasked randomised controlled 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 contact details to request a participant information sheet |
| Scientific title | Estimating neonatal oral endotracheal tube depth of insertion using weight or suprasternal palpation of the tip: a randomised controlled trial |
| Study acronym | NEDI 3 |
| Study hypothesis | Estimating the appropriate depth of insertion of oral endotracheal tubes in newborns using palpation of the tip of the endotracheal tube in the suprasternal notch is more accurate than using a weight based formula. |
| Ethics approval(s) | Research Ethics Committee, National Maternity Hospital, 14/11/2016, ref: EC 34.2016 |
| Condition | Endotracheal intubation of the newborn infant |
| Intervention | Infants who are intubated in the neonatal intensive care unit (NICU) will be randomised using sequentially numbered sealed opaque envelopes to have the depth of insertion estimated using: 1. Intervention: suprasternal palpation of the endotracheal tube (ETT) tip 2. Control: weight-based formula [insertion depth (cm) = weight (kg) + 6] All babies will have the ETT position checked with a chest X-ray. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | ETT tip in correct position (between upper border of T1 and lower border of T2) on chest X-ray (CXR) taken to confirm position immediately after intubation |
| Secondary outcome measures | 1. ETT tip above T1 on CXR taken to confirm position immediately after intubation 2. ETT tip below T2 on CXR taken to confirm position immediately after intubation 3. Number of extubations before CXR 4. Repositioning of ETT following CXR 5. Air leaks (pneumothorax, pneumomediastinum, pulmonary interstitial emphysema) occurring before hospital discharge (will vary for participants, usually depending on gestational age at birth) 6. Duration of ventilation, assessed before hospital discharge 7. Oxygen therapy at 28 days of life 8. Oxygen therapy at 36 weeks corrected gestational age 9. Death before discharge from hospital |
| Overall study start date | 01/12/2016 |
| Overall study end date | 30/06/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 116 |
| Total final enrolment | 118 |
| Participant inclusion criteria | Newborn infants of any gestational age and either gender intubated in NICU |
| Participant exclusion criteria | Infants with upper airway anomalies (e.g. Pierre-Robin sequence) or lung abnormalities (e.g. congenital diaphragmatic hernia) that may distort the upper airway anatomy and alter the position of the ETT tip on CXR |
| Recruitment start date | 02/12/2016 |
| Recruitment end date | 31/12/2018 |
Locations
Countries of recruitment
- Ireland
Study participating centre
Dublin
D02 YH21
Ireland
Sponsor information
Hospital/treatment centre
Neonatal Unit
Holles Street
Dublin
D02 YH21
Ireland
"ROR" |
https://ror.org/03jcxa214 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 30/06/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Findings will be presented at international scientific conferences (e.g. European Society for Paediatric Research, Pediatric Academic Societies) before submitting them in a manuscript for publication at a peer-reviewed scientific journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Prof. Colm O'Donnell. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2020 | 09/06/2020 | Yes | No |
Editorial Notes
09/06/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
