Confirmation of Tube Placement in Newborns
Primary Purpose
Respiratory Distress Syndrome, Apnea of Newborn
Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Nostril-Tragus-Length
Vocal cord marking
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Distress Syndrome
Eligibility Criteria
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.
Sites / Locations
- Royal Alexandra Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Nostril-Tragus-Length
Vocal cord markings
Arm Description
Outcomes
Primary Outcome Measures
Number of endotracheal tubes correctly placed within the trachea
Secondary Outcome Measures
Mortality in the Neonatal Intensive Care Unit
We will record the number of infants who die during their admission
Necrotizing Enterocolitis
We will record the number of infants who are diagnosed with Necrotizing Enterocolitis
Patent Ductus Arteriosus
We will record the number of infants who are diagnosed with Patent Ductus Arteriosus
Intraventricular hemorrhage all grades
We will record the number of infants who are diagnosed with intraventricular hemorrhage
Bronchopulmonary Dysplasia at
We will record the number of infants who are diagnosed with Bronchopulmonary Dysplasia
Changes in oxygen saturation during intubation procedure
During intubation we will record the lowest oxygen saturation
Changes in Heart rate during intubation procedure
During intubation we will record the lowest heart rate.
Duration of Intubation procedure
During Intubation, we will measure time from end of mask ventilation to connection of the ventilation device to ETT
Airway injury observed during intubation (including blood, swollen cords, vocal cord redness)
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05229887
Brief Title
Confirmation of Tube Placement in Newborns
Official Title
Confirmation of Tube Placement in Newborns
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Withdrawn
Why Stopped
need to be redesigned
Study Start Date
July 4, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome, Apnea of Newborn
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nostril-Tragus-Length
Arm Type
Active Comparator
Arm Title
Vocal cord markings
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Nostril-Tragus-Length
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Vocal cord marking
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of endotracheal tubes correctly placed within the trachea
Time Frame
within 30 minutes after endotracheal intubation
Secondary Outcome Measure Information:
Title
Mortality in the Neonatal Intensive Care Unit
Description
We will record the number of infants who die during their admission
Time Frame
0-200 days
Title
Necrotizing Enterocolitis
Description
We will record the number of infants who are diagnosed with Necrotizing Enterocolitis
Time Frame
0-200 days
Title
Patent Ductus Arteriosus
Description
We will record the number of infants who are diagnosed with Patent Ductus Arteriosus
Time Frame
0-200 days
Title
Intraventricular hemorrhage all grades
Description
We will record the number of infants who are diagnosed with intraventricular hemorrhage
Time Frame
0-200 days
Title
Bronchopulmonary Dysplasia at
Description
We will record the number of infants who are diagnosed with Bronchopulmonary Dysplasia
Time Frame
36 weeks corrected gestational age
Title
Changes in oxygen saturation during intubation procedure
Description
During intubation we will record the lowest oxygen saturation
Time Frame
0 to 60 seconds
Title
Changes in Heart rate during intubation procedure
Description
During intubation we will record the lowest heart rate.
Time Frame
0 to 60 seconds
Title
Duration of Intubation procedure
Description
During Intubation, we will measure time from end of mask ventilation to connection of the ventilation device to ETT
Time Frame
0 to 60 seconds
Title
Airway injury observed during intubation (including blood, swollen cords, vocal cord redness)
Description
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
Time Frame
0 to 60 seconds
10. Eligibility
Sex
All
Maximum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georg Schmolzer
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Alexandra Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H 3V9
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Investigators can contact the PI to discuss to use the collected data
Learn more about this trial
Confirmation of Tube Placement in Newborns
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