Intubation ComplicationIntubated-DRNCT03770104
Correct Endotracheal Tube Position in Newborns Intubated in the Delivery Room
A study testing ETT insertion depth using Spanish recommendations and ETT insertion depth using international recommendations in people with Intubation Complication and Newborn Morbidity, run by Tania Carbayo Jiménez at 1 site in Spain.
Trial summary
The investigators wished to determine whether estimating endotracheal tube (ETT) insertion depth using the formula given by Spanish guidelines recommendations (5,5 plus weight) rather than the depth using the formula given by international guidelines recommendations (6 plus weight) resulted in more correctly… Read more about this study
- Who is it for?
- Ages Up to 1 day
- Conditions the study is for
- Intubation Complication, Newborn Morbidity, Cardiopulmonary Resuscitation
- What is being tested?
- ETT insertion depth using Spanish recommendations and ETT insertion depth using international recommendations
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2019to Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 day
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All newborns requiring endotracheal oral intubation in the delivery room after birth.
- Parents accept deferred informed consent to participate in the study.
Who cannot join
- Prior to randomization
- Uncontrolled gestation where both estimated fetal weight and gestational age are unknown.
- Upper airway anomaly or a lung anomaly that would distort the upper airway anatomy.
- Infants who require nasotracheal intubation
- Infants who are intubated in the Neonatal Intensive Care Unit
- Post-randomization
Show all 9Show fewer
- Newborns who are randomized but finally do not require intubation
- Intubated newborns who are electively extubated in the delivery room
- Parents / legal guardian refuse to give consent to participate in the study
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario 12 de Octubre. Neonatology Department.
Madrid, 28041
María Soriano-Ramos, M.D., 0034 91390 8272
About this study
Official title: Correct Endotracheal Tube Position in Newborns Intubated in the Delivery Room According to Two Different Methods Based on Estimated Birth Weight. Randomized Clinical Trial (NeoTEDI)
The investigators wished to determine whether estimating endotracheal tube (ETT) insertion depth using the formula given by Spanish guidelines recommendations (5,5 plus weight) rather than the depth using the formula given by international guidelines recommendations (6 plus weight) resulted in more correctly positioned endotracheal tube tips in newborns intubated in the delivery room.
Read the detailed description
A number of different methods have been used to guide clinicians in estimating the correct depth of insertion of endotracheal tube (ETT) at the time of oral intubation. Minor differences in tube length may lead to intubation of the right main bronchus or extubation. However, none of them has shown to be better than others when compared in the context of randomized clinical trials.
Commonly, clinicians use a formula based on the newborn's weight (Tochen formula: ETT insertion depth (cm)=6 + wt (kg)). While this method is widely used and recommended by international guidelines, it has been found to frequently result in incorrectly positioned tubes, especially in infants <1000 g in weight in whom it may lead to overestimation of ETT insertion depth.
On the other hand, Spanish Society of Neonatology recommended in their last published guidelines (2017) to use an alternative version formula (ETT insertion depth (cm)=5.5 + wt (kg)), which is commonly used among Spanish neonatal units.
Finally, no studies have been performed in newborns who require oral intubation in the delivery room, since these intubations are usually excluded because infants are not routinely weighed prior to resuscitation and weight can not be rapidly obtained. Given that Obstetric Unit in our hospital is a high standard one with a highly reliable estimated fetal weight in prenatal ultrasound, the investigators will use estimated fetal weight referred on ultrasounds or 50th percentile for gestational age for calculations.
- Being tested
- ETT insertion depth using Spanish recommendations, ETT insertion depth using international recommendations
- Keywords
- Intubation, Newborn, Delivery room, Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ETT insertion depth using Spanish recommendationsProcedure or surgery
Infants included in this assignment group will be intubated using the formula 5.5 plus weight, when requiring oral intubation in the delivery room.
ETT insertion depth using international recommendationsProcedure or surgery
Infants included in this assignment group will be intubated using the formula 6 plus weight, when requiring oral intubation in the delivery room.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (5.5 plus weight) | Experimental | ETT insertion depth using Spanish recommendations Patients included in the intervention group arm who are included in the study will be intubated using Spanish recommendations (5.5 plus weight) to estimate insertion endotracheal tube depth. In addition, every arm will be divided into 2 subgroups depending on gestational age (under 32 weeks or equal/over 32 weeks' gestation). Receives: Procedure: ETT insertion depth using Spanish recommendations |
| Control Group (6 plus weight) | Experimental | ETT insertion depth using international recommendations Patients included in the intervention group arm who are included in the study will be intubated using international recommendations (6 plus weight) to estimate insertion endotracheal tube depth. In addition, every arm will be divided into 2 subgroups depending on gestational age (under 32 weeks or equal/over 32 weeks' gestation). Receives: Procedure: ETT insertion depth using international recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of correct endotracheal tube (ETT) position
Correct ETT position, that is, tip between the upper border of the first thoracic vertebra (T1) and the lower border of the second thoracic vertebra (T2) on a chest X-ray as determined by one pediatric radiologist masked to group assignment.
Measured: 1 hour
Secondary outcomes (9)
Number of intubation attempts in the delivery room
Number of intubation attempts in the delivery room by healthcare professionals
Measured: 2 days
Number of accidental extubations prior to chest X-ray
Number of accidental extubations prior to chest X-ray confirmation of ETT position
Measured: 2 days
Frequency of ETT repositioning prior and after chest X-ray
ETT repositioning prior and after chest X-ray
Measured: 2 days
Frequency of incorrect ETT position
Incorrect ETT position (too low or too high)
Measured: 2 days
Frequency of complications secondary to incorrect ETT position
Complications secondary to incorrect ETT position (air leak, unplanned extubation, atelectasis)
Measured: 7 days
Professional healthcare sensation about correct or incorrect ETT position
Professional healthcare sensation about correct or incorrect ETT position, before confirmation with Chest X-ray confirmation
Measured: 1 day
Duration of ventilation
Duration of ventilation in days
Measured: 3 months
Oxygen therapy at 28 days
Oxygen therapy at 28 days
Measured: 1 month
Oxygen therapy at 36 weeks postmenstrual age
Oxygen therapy at 36 weeks postmenstrual age
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2018
- Study start1 Jan 2019
- Primary completionJan 2022 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Intubation ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tania Carbayo Jiménez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tania Carbayo Jiménez, Hospital Universitario 12 de Octubre
- Investigators
- Tania Carbayo Jimenez, M.D., Study chair, Hospital Universitario 12 de Octubre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03770104
- Sponsor's protocol ID
- Neo TEDI
- Acronym
- Intubated-DR
- Status last verified
- Jun 2021
- First submitted
- 5 Dec 2018
- Last updated
- 16 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Flinn AM, Travers CP, Laffan EE, O'Donnell CP. Estimating the endotracheal tube insertion depth in newborns using weight or gestation: a randomised trial. Neonatology. 2015;107(3):167-72. doi: 10.1159/000369375.
PubMed 25592171Gill I, Stafford A, Murphy MC, Geoghegan AR, Crealey M, Laffan E, O'Donnell CPF. Randomised trial of estimating oral endotracheal tube insertion depth in newborns using weight or vocal cord guide. Arch Dis Child Fetal Neonatal Ed. 2018 Jul;103(4):F312-F316. doi: 10.1136/archdischild-2017-312798. Epub 2017 Sep 7.
PubMed 28883098Tochen ML. Orotracheal intubation in the newborn infant: a method for determining depth of tube insertion. J Pediatr. 1979 Dec;95(6):1050-1. doi: 10.1016/s0022-3476(79)80309-1. No abstract available.
PubMed 501484Amarilyo G, Mimouni FB, Oren A, Tsyrkin S, Mandel D. Orotracheal tube insertion in extremely low birth weight infants. J Pediatr. 2009 May;154(5):764-5. doi: 10.1016/j.jpeds.2008.11.057.
PubMed 19364561Peterson J, Johnson N, Deakins K, Wilson-Costello D, Jelovsek JE, Chatburn R. Accuracy of the 7-8-9 Rule for endotracheal tube placement in the neonate. J Perinatol. 2006 Jun;26(6):333-6. doi: 10.1038/sj.jp.7211503.
PubMed 16642028Kempley ST, Moreiras JW, Petrone FL. Endotracheal tube length for neonatal intubation. Resuscitation. 2008 Jun;77(3):369-73. doi: 10.1016/j.resuscitation.2008.02.002. Epub 2008 Mar 26.
PubMed 18372092
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correct Endotracheal Tube Position in Newborns Intubated in the Delivery Room According to Two Different Methods Based on Estimated Birth Weight. Randomized Clinical Trial (NeoTEDI)
- ClinicalTrials.gov ID
- NCT03770104
- Acronym / sponsor ID
- Intubated-DR / Neo TEDI
- Keywords
- Intubation, Newborn, Delivery room, Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Tania Carbayo JiménezUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 10 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators wished to determine whether estimating endotracheal tube (ETT) insertion depth using the formula given by Spanish guidelines recommendations (5,5 plus weight) rather than the depth using the formula given by international guidelines recommendations (6 plus weight) resulted in more correctly positioned endotracheal tube tips in newborns intubated in the delivery room.
Detailed description
A number of different methods have been used to guide clinicians in estimating the correct depth of insertion of endotracheal tube (ETT) at the time of oral intubation. Minor differences in tube length may lead to intubation of the right main bronchus or extubation. However, none of them has shown to be better than others when compared in the context of randomized clinical trials.
Commonly, clinicians use a formula based on the newborn's weight (Tochen formula: ETT insertion depth (cm)=6 + wt (kg)). While this method is widely used and recommended by international guidelines, it has been found to frequently result in incorrectly positioned tubes, especially in infants <1000 g in weight in whom it may lead to overestimation of ETT insertion depth.
On the other hand, Spanish Society of Neonatology recommended in their last published guidelines (2017) to use an alternative version formula (ETT insertion depth (cm)=5.5 + wt (kg)), which is commonly used among Spanish neonatal units.
Finally, no studies have been performed in newborns who require oral intubation in the delivery room, since these intubations are usually excluded because infants are not routinely weighed prior to resuscitation and weight can not be rapidly obtained. Given that Obstetric Unit in our hospital is a high standard one with a highly reliable estimated fetal weight in prenatal ultrasound, the investigators will use estimated fetal weight referred on ultrasounds or 50th percentile for gestational age for calculations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (5.5 plus weight) | Experimental | Procedure: ETT insertion depth using Spanish recommendationsETT insertion depth using Spanish recommendations Patients included in the intervention group arm who are included in the study will be intubated using Spanish recommendations (5.5 plus weight) to estimate insertion endotracheal tube depth. In addition, every arm will be divided into 2 subgroups depending on gestational age (under 32 weeks or equal/over 32 weeks' gestation). |
| Control Group (6 plus weight) | Experimental | Procedure: ETT insertion depth using international recommendationsETT insertion depth using international recommendations Patients included in the intervention group arm who are included in the study will be intubated using international recommendations (6 plus weight) to estimate insertion endotracheal tube depth. In addition, every arm will be divided into 2 subgroups depending on gestational age (under 32 weeks or equal/over 32 weeks' gestation). |
Who may qualify
- Ages
- Up to 1 day
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- All newborns requiring endotracheal oral intubation in the delivery room after birth.
- Parents accept deferred informed consent to participate in the study.
Key exclusion criteria (9 listed)
- Prior to randomization
- Uncontrolled gestation where both estimated fetal weight and gestational age are unknown.
- Upper airway anomaly or a lung anomaly that would distort the upper airway anatomy.
- Infants who require nasotracheal intubation
- Infants who are intubated in the Neonatal Intensive Care Unit
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ETT insertion depth using Spanish recommendationsInfants included in this assignment group will be intubated using the formula 5.5 plus weight, when requiring oral intubation in the delivery room. | Procedure or surgery | Intervention Group (5.5 plus weight) |
| ETT insertion depth using international recommendationsInfants included in this assignment group will be intubated using the formula 6 plus weight, when requiring oral intubation in the delivery room. | Procedure or surgery | Control Group (6 plus weight) |
Primary outcome
Frequency of correct endotracheal tube (ETT) position
Time frame: 1 hour
Correct ETT position, that is, tip between the upper border of the first thoracic vertebra (T1) and the lower border of the second thoracic vertebra (T2) on a chest X-ray as determined by one pediatric radiologist masked to group assignment.
9 secondary outcomes
Number of intubation attempts in the delivery room
Time frame: 2 days
Number of accidental extubations prior to chest X-ray
Time frame: 2 days
Frequency of ETT repositioning prior and after chest X-ray
Time frame: 2 days
Frequency of incorrect ETT position
Time frame: 2 days
Frequency of complications secondary to incorrect ETT position
Time frame: 7 days
Professional healthcare sensation about correct or incorrect ETT position
Time frame: 1 day
Duration of ventilation
Time frame: 3 months
Oxygen therapy at 28 days
Time frame: 1 month
Oxygen therapy at 36 weeks postmenstrual age
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2021.
- Background: PubMed 25592171Flinn AM, Travers CP, Laffan EE, O'Donnell CP. Estimating the endotracheal tube insertion depth in newborns using weight or gestation: a randomised trial. Neonatology. 2015;107(3):167-72. doi: 10.1159/000369375.
- Background: PubMed 28883098Gill I, Stafford A, Murphy MC, Geoghegan AR, Crealey M, Laffan E, O'Donnell CPF. Randomised trial of estimating oral endotracheal tube insertion depth in newborns using weight or vocal cord guide. Arch Dis Child Fetal Neonatal Ed. 2018 Jul;103(4):F312-F316. doi: 10.1136/archdischild-2017-312798. Epub 2017 Sep 7.
- Background: PubMed 501484Tochen ML. Orotracheal intubation in the newborn infant: a method for determining depth of tube insertion. J Pediatr. 1979 Dec;95(6):1050-1. doi: 10.1016/s0022-3476(79)80309-1. No abstract available.
- Background: PubMed 19364561Amarilyo G, Mimouni FB, Oren A, Tsyrkin S, Mandel D. Orotracheal tube insertion in extremely low birth weight infants. J Pediatr. 2009 May;154(5):764-5. doi: 10.1016/j.jpeds.2008.11.057.
- Background: PubMed 16642028Peterson J, Johnson N, Deakins K, Wilson-Costello D, Jelovsek JE, Chatburn R. Accuracy of the 7-8-9 Rule for endotracheal tube placement in the neonate. J Perinatol. 2006 Jun;26(6):333-6. doi: 10.1038/sj.jp.7211503.
- Background: PubMed 18372092Kempley ST, Moreiras JW, Petrone FL. Endotracheal tube length for neonatal intubation. Resuscitation. 2008 Jun;77(3):369-73. doi: 10.1016/j.resuscitation.2008.02.002. Epub 2008 Mar 26.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tania Carbayo Jimenez, M.D. study chair
Hospital Universitario 12 de Octubre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ETT insertion depth using Spanish recommendations and ETT insertion depth using international recommendations in people with Intubation Complication and Newborn Morbidity, run by Tania Carbayo Jiménez at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tania Carbayo Jimenez, M.D. (0034 91 390 8272, tania.carbayo@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of correct endotracheal tube (ETT) position (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03770104, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2021.