Intubated-DR: Correct Endotracheal Tube Position in Newborns Intubated in the Delivery Room
Study Details
Study Description
Brief 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 positioned endotracheal tube tips in newborns intubated in the delivery room.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention Group (5.5 plus weight) 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). |
Procedure: ETT insertion depth using Spanish recommendations
Infants included in this assignment group will be intubated using the formula 5.5 plus weight, when requiring oral intubation in the delivery room.
|
| Experimental: Control Group (6 plus weight) 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). |
Procedure: ETT insertion depth using international recommendations
Infants included in this assignment group will be intubated using the formula 6 plus weight, when requiring oral intubation in the delivery room.
|
Outcome Measures
Primary Outcome Measures
- Frequency of correct endotracheal tube (ETT) position [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.
Secondary Outcome Measures
- Number of intubation attempts in the delivery room [2 days]
Number of intubation attempts in the delivery room by healthcare professionals
- Number of accidental extubations prior to chest X-ray [2 days]
Number of accidental extubations prior to chest X-ray confirmation of ETT position
- Frequency of ETT repositioning prior and after chest X-ray [2 days]
ETT repositioning prior and after chest X-ray
- Frequency of incorrect ETT position [2 days]
Incorrect ETT position (too low or too high)
- Frequency of complications secondary to incorrect ETT position [7 days]
Complications secondary to incorrect ETT position (air leak, unplanned extubation, atelectasis)
- Professional healthcare sensation about correct or incorrect ETT position [1 day]
Professional healthcare sensation about correct or incorrect ETT position, before confirmation with Chest X-ray confirmation
- Duration of ventilation [3 months]
Duration of ventilation in days
- Oxygen therapy at 28 days [1 month]
Oxygen therapy at 28 days
- Oxygen therapy at 36 weeks postmenstrual age [3 months]
Oxygen therapy at 36 weeks postmenstrual age
Other Outcome Measures
- Presence of intraventricular hemorrhage or central nervous system lesion [3 months]
Presence of intraventricular hemorrhage or central nervous system lesion
- Death before discharge from the hospital [4 months]
Death before discharge from the hospital
Eligibility Criteria
Criteria
Inclusion Criteria:
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All newborns requiring endotracheal oral intubation in the delivery room after birth.
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Parents accept deferred informed consent to participate in the study.
Exclusion Criteria:
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Prior to randomization
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Uncontrolled gestation where both estimated fetal weight and gestational age are unknown.
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Upper airway anomaly or a lung anomaly that would distort the upper airway anatomy.
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Infants who require nasotracheal intubation
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Infants who are intubated in the Neonatal Intensive Care Unit
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Post-randomization
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Newborns who are randomized but finally do not require intubation
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Intubated newborns who are electively extubated in the delivery room
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Parents / legal guardian refuse to give consent to participate in the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Universitario 12 de Octubre. Neonatology Department. | Madrid | Spain | 28041 |
Sponsors and Collaborators
- Tania Carbayo Jiménez
Investigators
- Study Chair: Tania Carbayo Jimenez, M.D., Hospital Universitario 12 de Octubre
Study Documents (Full-Text)
None provided.More Information
Publications
- Amarilyo 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.
- 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.
- Gill 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.
- Kempley 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.
- Peterson 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.
- Tochen ML. Orotracheal intubation in the newborn infant: a method for determining depth of tube insertion. J Pediatr. 1979 Dec;95(6):1050-1.
- Neo TEDI