Confirmation of Tube Placement in Newborns

Sponsor
University of Alberta (Other)
Overall Status
Recruiting
CT.gov ID
NCT05229887
Collaborator
(none)
292
1
2
32.9
8.9

Study Details

Study Description

Brief Summary

Tracheal intubation remains a common procedure in the neonatal intensive care unit (NICU) and the delivery room (DR).

Current guidelines recommend Estimation of correct endotracheal tube (ETT) insertion Our hospital policy recommends to estimate the correct depth (cm) of tube placement by measuring the nasal-ear-tragus length using the "7-8-9 rule" when the endotracheal tube is placed orally. Using this formula an infant weighing 1kg would be intubated to a depth of 7cm, a 2kg infant to a depth of 8cm, and a 3kg infant to a depth of 9cm from the upper lip.

With the new 2015 guidelines, ETT depth is determined by measuring the newborn's nasal septum-tragus length (NTL) and adding 1cm or by using the "initial endotracheal tube insertion depth" table. The NTL is described as the distance from the base of the nasal septum to the tragus of the ear.

However, studies using NTL reported that using this technique only resulted in correct ETT placement in 56% of cases.

Every ETT has markings on the tube, which are called vocal cord markings, which are to be used to provide a guidance to how deep to place the ETT into the trachea. There has been npc study to compare the vocal cord markings with the current approach of NTL.

The current study aims to determine if the use of vocal cord markings during intubation increases percentage of correct endotracheal tube placement compared to NTL in preterm and term infants.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Nostril-Tragus-Length
  • Procedure: Vocal cord marking
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
292 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Confirmation of Tube Placement in Newborns
Actual Study Start Date :
Jul 4, 2022
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Mar 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Nostril-Tragus-Length

Procedure: Nostril-Tragus-Length
Endotracheal tube depth is determined by measuring the newborn's nasal septum-tragus length (NTL) and adding 1cm. The NTL is described as the distance from the base of the nasal septum to the tragus of the ear.

Experimental: Vocal cord markings

Procedure: Vocal cord marking
The endotracheal tube has markings on the tube, which are called vocal cord markings, which will be used to provide a guidance to how deep to place the ETT into the trachea.

Outcome Measures

Primary Outcome Measures

  1. Number of endotracheal tubes correctly placed within the trachea [within 30 minutes after endotracheal intubation]

Secondary Outcome Measures

  1. Mortality in the Neonatal Intensive Care Unit [0-200 days]

    We will record the number of infants who die during their admission

  2. Necrotizing Enterocolitis [0-200 days]

    We will record the number of infants who are diagnosed with Necrotizing Enterocolitis

  3. Patent Ductus Arteriosus [0-200 days]

    We will record the number of infants who are diagnosed with Patent Ductus Arteriosus

  4. Intraventricular hemorrhage all grades [0-200 days]

    We will record the number of infants who are diagnosed with intraventricular hemorrhage

  5. Bronchopulmonary Dysplasia at [36 weeks corrected gestational age]

    We will record the number of infants who are diagnosed with Bronchopulmonary Dysplasia

  6. Changes in oxygen saturation during intubation procedure [0 to 60 seconds]

    During intubation we will record the lowest oxygen saturation

  7. Changes in Heart rate during intubation procedure [0 to 60 seconds]

    During intubation we will record the lowest heart rate.

  8. Duration of Intubation procedure [0 to 60 seconds]

    During Intubation, we will measure time from end of mask ventilation to connection of the ventilation device to ETT

  9. Airway injury observed during intubation (including blood, swollen cords, vocal cord redness) [0 to 60 seconds]

    Observed by the person who performs the intubation by looking for blood, swollen cords, redness. There is no score or questionnaire. The operator will only assess these with yes or no

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 3 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • All infants (term and preterm) born at The Royal Alexandra Hospital who require endotracheal intubation in the delivery room or/and Neonatal Intensive Care Unit will be eligible.
Exclusion Criteria:
  • Infants will be excluded if their parents refuse to give consent to this study.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Royal Alexandra Hospital Edmonton Alberta Canada T5H 3V9

Sponsors and Collaborators

  • University of Alberta

Investigators

  • Principal Investigator: Georg Schmolzer, University of Alberta

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Alberta
ClinicalTrials.gov Identifier:
NCT05229887
Other Study ID Numbers:
  • Pro00116201
First Posted:
Feb 8, 2022
Last Update Posted:
Jul 8, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 8, 2022