Estimating Length of Endotracheal Tube Insertion Using Gestational Age or Nasal-Tragus Length in Newborn Infants

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Brief Title

Estimating Length of Endotracheal Tube Insertion Using Gestational Age or Nasal-Tragus Length in Newborn Infants

Official Title

Gestational Age Versus Nasal-tragus Length for Estimating Endotracheal Tube Insertion Depth in Newborns - A Randomised Trial

Brief Summary

      Endotracheal intubation is a life-saving intervention that few infants need after birth.
      Although an endotracheal tube is the most reliable way of providing positive-pressure breath,
      the critical factor that determines the maximal efficacy of positive-pressure ventilation is
      the optimal placement of the endotracheal tube tip. There are various methods available to
      determine the initial depth of endotracheal tube (ETT) that are based on the infant's birth
      weight, gestational age, anthropometric measurements, and others include vocal cord guide and
      suprasternal palpation methods.

      The Neonatal Resuscitation Program (NRP) textbook, in its 7th edition of the textbook,
      recommends a gestational age chart and nasal-tragus length method for estimating endotracheal
      tube insertion depth during cardiopulmonary resuscitation of the neonate. The evidence to
      support these two methods is, however, limited. Hence, we designed this study to determine
      the accuracy of two methods, gestational age chart and nasal-tragus length method,
      recommended by the Neonatal Resuscitation Program.
    

Detailed Description

      Trial Objective: To determine whether estimating ETT insertion depth using gestational age
      chart rather than nasal-tragus length method results in more correctly positioned ETT tips.

      Setting: The neonates will be recruited from multiple tertiary-level neonatal intensive care
      units in Saudi Arabia. A neonate can participate in more than one clinical trial, depending
      on the interventions being given. Parallel run trials will be discussed between the chief and
      local principal investigators whether or not joint recruitment is feasible to both parties.

      Informed Consent: We will obtain written consent after the parents have been given a full
      verbal explanation and written description. We will explain to the parents in their own
      native language. We will use a hospital-based adult interpreter wherein required. We will
      obtain deferred consent (after initial verbal assent) where prior consent is not feasible as
      the study does not involve additional risk or investigations to the participants, and the
      interventions are otherwise considered as standard practice recommendations by the NRP.

      Data Safety Monitoring Board: Any unexpected serious events (death, any life-threatening
      event, any event that will prolong the hospitalization or any event that will result in
      disability) will be reported to the data safety monitoring committee. The trial steering
      committee will receive recommendations from the data safety monitoring board if the trial
      requires early termination following the interim data analyses and evidence from relevant
      studies. The following measures were agreed to consider stopping the trial, wholly or partly
      (subgroups), after an interim analysis, that will be done after recruiting 200 participants.

        1. An absolute difference of greater than or equal to 25% in the primary outcome between
           the study groups.

        2. An absolute difference of less than 5% in the primary outcome between the study groups.

        3. A rate of less than 20% in the primary outcome in either of the groups.

      Sample Size: Our unpublished data showed using the nasal-tragus length method results in 35%
      of correctly positioned ETT tips in term and preterm infants. The data is similar to the
      randomized and non-randomized studies that showed an accuracy between 32 and 37 percent using
      the nasal-tragus length method. With 90% power and two-sided 5% significance, to detect an
      absolute increase in optimally positioned ETT tips of 15%, we will require 454 participants.
      We calculated sample size using nQuery Advisor Sample Size Calculator version 8.3.0.0.

      Statistical Analysis: We will analyze the data based on the intention-to-treat principle.
      Univariate analyses will be performed to compare baseline demographic factors between the two
      groups. A mean with standard deviation (normal data) or median with interquartile range
      (skewed data) will be obtained for continuous variables and numbers and percentages for
      categorical variables. Independent T-test (normal data) or Mann Whitney U test (skewed data)
      for continuous variables and chi-square test (or Fisher's exact test as appropriate) for
      categorical variables will be used for analyses between the groups. Statistical Analysis
      Software version 9.4 will be used for the conduct of all analyses.

      Analysis of primary outcome: Adjusted risk ratios of a successful outcome will be calculated
      along with 95% confidence intervals. Adjusted ratios will be determined by way of
      multivariable logistic regression analysis, including co-variates deemed biologically to have
      an influence on the primary outcome (gestational age, small for gestational age, and center).
      Principles of best model practices will be followed (including assessment of collinearity
      amongst included variables) as well as the determination of the predictive ability of the
      model using area under the curve.

      Analysis of secondary outcomes: Similar analyses as above will be performed for all secondary
      outcomes that are categorical variables. The risk ratios of secondary outcomes mortality,
      oxygen therapy at 28 days, pneumothorax, and bronchopulmonary dysplasia will be adjusted
      based on the following variables: gestational age, male sex, small for gestational age,
      maternal hypertension, chorioamnionitis, antenatal steroids, and center if the P-value is
      less than 0.25 on univariate analysis.
    


Study Type

Interventional


Primary Outcome

Proportion of infants with optimally positioned endotracheal tube tip on the chest X-ray

Secondary Outcome

 Proportion of infants with endotracheal tube tip above T1 vertebra

Condition

Endotracheal Tube Tip Position

Intervention

Gestational Age Chart Method

Study Arms / Comparison Groups

 Gestational Age Chart Method
Description:  In this method, the endotracheal tube insertion depth is obtained from the gestational age chart provided in the 7th edition textbook of neonatal resuscitation program (adapted from Kempley et al. PubMed identifier number: 18372092)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

454

Start Date

June 24, 2020

Completion Date

September 2022

Primary Completion Date

June 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Infants (less than 28 days of life) between 23 weeks 0 days and 41 weeks 6 days
             gestational age

          -  Infants requiring oral intubation in the delivery room or in neonatal intensive care
             unit

        Exclusion Criteria:

          -  Infants with major chromosomal anomalies, including trisomy 13, trisomy 18, and
             trisomy 21

          -  Infants with major anomalies, including craniofacial anomalies and facial dysmorphism
             that may affect the nasal-tragus length
      

Gender

All

Ages

N/A - 28 Days

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

Saudi Arabia

Location Countries

Saudi Arabia

Administrative Informations


NCT ID

NCT04393337

Organization ID

20-0148


Responsible Party

Principal Investigator

Study Sponsor

Princess Nourah Bint Abdulrahman University

Collaborators

 King Fahad Medical City

Study Sponsor

, , 


Verification Date

September 2020