Estimating the depth of insertion of oral endotracheal tubes in newborns using weight or vocal cord guide

ISRCTN	ISRCTN39654846
DOI	https://doi.org/10.1186/ISRCTN39654846
Secondary identifying numbers	NEDI2001

Submission date: 03/09/2013
Registration date: 14/10/2013
Last edited: 21/01/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Neonatal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Many newborn babies receive help for breathing difficulties after birth. Some of these infants are have a tube (an endotracheal tube - ETT) inserted into their windpipe for support with a ventilator. ETTs have markings at 1cm intervals from the tip so that it is known how far it has been inserted. ETTs also have a marker, the vocal cord guide, 2.5 3cm from the tip. It is important that the ETT is inserted far enough so that it is within the windpipe, but not too far so that the lungs are not ventilated evenly. The position of the ETT tip is confirmed using a chest X-ray. Currently, doctors estimate how far they should insert ETTs in a newborn using a formula based on the babys birth weight. Half of the ETTs are not in the correct position when the insertion depth is estimated using this method. It may be more accurate to use the vocal cord guide. We aim to determine whether estimating the insertion depth of ETTs in newborns with the vocal cord guide, compared to weight, results in more correctly-placed ETTs on chest X-rays.

Who can participate?
Newborn infants who are being intubated (tube inserted) in the Neonatal Intensive Care Unit (NICU) can participate in the study.

What does the study involve?
Newborns are randomly allocated to one of two groups: estimation of ETT insertion depth using the weight-based formula or the vocal cord guide. Correct position of the ETT insertion is found using an X-ray by a specialist.

What are the possible benefits and risks of participating?
Infants will not have additional investigations or treatments by virtue of their participation in the study.
There are no risks in participating above those that already exist due to intubation in an intensive care.

Where is the study run from?
The study is run from the National Maternity Hospital, Holles Street, Dublin, Ireland.

When is study starting and how long is it expected to run for?
The study started in September 2013 and is expected to run for 12 months.

Who is funding the study?
The National Childrens Research Centre, Dublin, Ireland.

Who is the main contact?
Dr. Colm ODonnell
codonnell@nmh.ie

Contact information

Dr Colm O'Donnell
Scientific

Neonatal Intensive Care Unit
The National Maternity Hospital
Holles Street
Dublin
2
Ireland

Phone	+353 (1) 637 3100
Email	codonnell@nmh.ie

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Estimating Neonatal oral Endotracheal tube Depth of Insertion using weight or vocal cord guide
Study acronym	NEDI2
Study objectives	Estimating the appropriate depth of insertion of oral endotracheal tubes (ETT) in newborns using the vocal cord guide is more accurate than using a weight based formula.
Ethics approval(s)	Ethics Committee at the National Maternity Hospital, Dublin, Ireland; 25/06/2013
Health condition(s) or problem(s) studied	Neonatal intensive care, respiratory support, mechanical ventilation
Intervention	Newborns are randomised to two groups: 1. Oral ETT insertion depth estimated using a weight-basd formula [insertion depth (cm) = 6 + birth weight (kg)] 2. Operators assessment that the top of the vocal cord guide is still visible
Intervention type	Other
Primary outcome measure	Correct position of the ETT on chest X-ray defined as between the upper border of the first thoracic vertebra (T1) and the lower border of the second thoracic vertebra (T2) on chest X-ray. ETT position will be determined by a consultant paediatric radiologist who will be unaware of the infants treatment allocation.
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	16/09/2013
Completion date	30/06/2014

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	Both
Target number of participants	116
Key inclusion criteria	Newborn infants intubated in the neonatal intensive care unit (NICU)
Key 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 chest X-ray (CXR) are not eligible for inclusion.
Date of first enrolment	16/09/2013
Date of final enrolment	30/06/2014

Locations

Countries of recruitment

Ireland

Study participating centre

Neonatal Intensive Care Unit

Dublin
2
Ireland

Sponsor information

The National Maternity Hospital (Ireland)
Hospital/treatment centre

c/o Colm O'Donnell
Neonatal Intensive Care Unit
Holles Street
Dublin
2
Ireland

"ROR"	https://ror.org/03jcxa214

Funders

Funder type

Research organisation

National Children's Research Centre, Dublin (Ireland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2018	21/01/2019	Yes	No

Editorial Notes

21/01/2019: Publication reference added