NCT03770104

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 10, 2018

Completed
22 days until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

June 16, 2021

Status Verified

June 1, 2021

Enrollment Period

3 years

First QC Date

December 5, 2018

Last Update Submit

June 12, 2021

Conditions

Intubation ComplicationNewborn MorbidityCardiopulmonary Resuscitation

Keywords

IntubationNewbornDelivery roomComplications

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 hour

Secondary Outcomes (9)

  • Number of intubation attempts in the delivery room

    2 days

  • Number of accidental extubations prior to chest X-ray

    2 days

  • Frequency of ETT repositioning prior and after chest X-ray

    2 days

  • Frequency of incorrect ETT position

    2 days

  • Frequency of complications secondary to incorrect ETT position

    7 days

  • +4 more secondary outcomes

Other Outcomes (2)

  • Presence of intraventricular hemorrhage or central nervous system lesion

    3 months

  • Death before discharge from the hospital

    4 months

Study Arms (2)

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).

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).

Procedure: ETT insertion depth using international recommendations

Interventions

ETT insertion depth using Spanish recommendationsPROCEDURE

Infants included in this assignment group will be intubated using the formula 5.5 plus weight, when requiring oral intubation in the delivery room.

Intervention Group (5.5 plus weight)
ETT insertion depth using international recommendationsPROCEDURE

Infants included in this assignment group will be intubated using the formula 6 plus weight, when requiring oral intubation in the delivery room.

Control Group (6 plus weight)

Eligibility Criteria

AgeUp to 1 Day
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • All newborns requiring endotracheal oral intubation in the delivery room after birth.
  • Parents accept deferred informed consent to participate in the study.

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario 12 de Octubre. Neonatology Department.

Madrid, 28041, Spain

RECRUITING

Related Publications (6)

  • 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.

    PMID: 25592171BACKGROUND

  • 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.

    PMID: 28883098BACKGROUND

  • Tochen 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.

    PMID: 501484BACKGROUND

  • 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.

    PMID: 19364561BACKGROUND

  • 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. doi: 10.1038/sj.jp.7211503.

    PMID: 16642028BACKGROUND

  • 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.

    PMID: 18372092BACKGROUND

Study Officials

  • Tania Carbayo Jimenez, M.D.

    Hospital Universitario 12 de Octubre

    STUDY CHAIR

Central Study Contacts

Tania Carbayo Jimenez, M.D.

CONTACT

0034 91 390 8272tania.carbayo@salud.madrid.org

Carmen Rosa Pallás Alonso, M.D.; Ph.D.

CONTACT

0034 913908273carmenrosa.pallas@salud.madrid.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Clinicians and neonatal nurses will not masked to group assignment. However, Neonatal Intensive Care Unit nurses who take care of the patient will be mask, as well as both pediatric radiologist who will determine the main outcome of the study.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Tania Carbayo Jimenez, MD

Study Record Dates

First Submitted

December 5, 2018

First Posted

December 10, 2018

Study Start

January 1, 2019

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

June 16, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)