Respiratory Distress SyndromeNCT05229887
Confirmation of Tube Placement in Newborns
A study testing Nostril-Tragus-Length and Vocal cord marking in people with Respiratory Distress Syndrome and Apnea of Newborn, run by University of Alberta at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 3 months
- Conditions the study is for
- Respiratory Distress Syndrome, Apnea of Newborn
- What is being tested?
- Nostril-Tragus-Length and Vocal cord marking
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 4 Jul 2022to 31 Mar 2025
- 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 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Infants will be excluded if their parents refuse to give consent to this study.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Respiratory Distress Syndrome, Apnea of Newborn
- Being tested
- Nostril-Tragus-Length, Vocal cord marking
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nostril-Tragus-LengthProcedure or surgery
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.
Vocal cord markingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Nostril-Tragus-Length | Active comparator | Not described Receives: Procedure: Nostril-Tragus-Length |
| Vocal cord markings | Experimental | Not described Receives: Procedure: Vocal cord marking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of endotracheal tubes correctly placed within the trachea
Measured: within 30 minutes after endotracheal intubation
Secondary outcomes (9)
Mortality in the Neonatal Intensive Care Unit
We will record the number of infants who die during their admission
Measured: 0-200 days
Necrotizing Enterocolitis
We will record the number of infants who are diagnosed with Necrotizing Enterocolitis
Measured: 0-200 days
Patent Ductus Arteriosus
We will record the number of infants who are diagnosed with Patent Ductus Arteriosus
Measured: 0-200 days
Intraventricular hemorrhage all grades
We will record the number of infants who are diagnosed with intraventricular hemorrhage
Measured: 0-200 days
Bronchopulmonary Dysplasia at
We will record the number of infants who are diagnosed with Bronchopulmonary Dysplasia
Measured: 36 weeks corrected gestational age
Changes in oxygen saturation during intubation procedure
During intubation we will record the lowest oxygen saturation
Measured: 0 to 60 seconds
Changes in Heart rate during intubation procedure
During intubation we will record the lowest heart rate.
Measured: 0 to 60 seconds
Duration of Intubation procedure
During Intubation, we will measure time from end of mask ventilation to connection of the ventilation device to ETT
Measured: 0 to 60 seconds
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
Measured: 0 to 60 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start4 Jul 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Why it stopped: need to be redesigned
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Georg Schmolzer, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05229887
- Sponsor's protocol ID
- Pro00116201
- Status last verified
- Apr 2022
- First submitted
- 31 Jan 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Investigators can contact the PI to discuss to use the collected data
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confirmation of Tube Placement in Newborns
- ClinicalTrials.gov ID
- NCT05229887
- Acronym / sponsor ID
- Pro00116201
- Conditions
- Respiratory Distress Syndrome, Apnea of Newborn
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: need to be redesigned
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 4 Jul 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 8 Feb 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nostril-Tragus-Length | Active comparator | Procedure: Nostril-Tragus-Length |
| Vocal cord markings | Experimental | Procedure: Vocal cord marking |
Who may qualify
- Ages
- Up to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Infants will be excluded if their parents refuse to give consent to this study.
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 |
|---|---|---|
| Nostril-Tragus-LengthEndotracheal 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. | Procedure or surgery | Nostril-Tragus-Length |
| Vocal cord markingThe 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. | Procedure or surgery | Vocal cord markings |
Primary outcome
Number of endotracheal tubes correctly placed within the trachea
Time frame: within 30 minutes after endotracheal intubation
9 secondary outcomes
Mortality in the Neonatal Intensive Care Unit
Time frame: 0-200 days
Necrotizing Enterocolitis
Time frame: 0-200 days
Patent Ductus Arteriosus
Time frame: 0-200 days
Intraventricular hemorrhage all grades
Time frame: 0-200 days
Bronchopulmonary Dysplasia at
Time frame: 36 weeks corrected gestational age
Changes in oxygen saturation during intubation procedure
Time frame: 0 to 60 seconds
Changes in Heart rate during intubation procedure
Time frame: 0 to 60 seconds
Duration of Intubation procedure
Time frame: 0 to 60 seconds
Airway injury observed during intubation (including blood, swollen cords, vocal cord redness)
Time frame: 0 to 60 seconds
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Yes. Investigators can contact the PI to discuss to use the collected data
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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.
Georg Schmolzer principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nostril-Tragus-Length and Vocal cord marking in people with Respiratory Distress Syndrome and Apnea of Newborn, run by University of Alberta at 1 site in Canada.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 19 Sep 2024. 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 Canada. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of endotracheal tubes correctly placed within the trachea (time frame: within 30 minutes after endotracheal intubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.