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

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ClinicalTrials.gov Identifier: NCT04393337
Recruitment Status : Recruiting
First Posted : May 19, 2020
Last Update Posted : October 25, 2021
Sponsor:
Collaborators:
King Fahad Hospital
King Faisal Specialist Hospital & Research Center
Information provided by (Responsible Party):
Abdul Razak, Princess Nourah Bint Abdulrahman University

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.


Condition or disease Intervention/treatment Phase
Endotracheal Tube Tip Position Bronchopulmonary Dysplasia Pneumothorax Death Duration, Ventilator Other: Gestational Age Chart Method Other: Nasal-Tragus Length Method Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 454 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Eligible infants will be randomly assigned (1:1) to the 'gestational age chart' or 'nasal-tragus length' method We will stratify the randomization by gestational age at birth (<28 weeks and >28 weeks) and participating center. An independent researcher will generate the randomization sequence with a computer at the website www.sealedenvelope.com hosted by King Abdullah bin Abdulaziz University Hospital, Saudi Arabia. The researcher will upload the sequence to the in-built randomization module within the Research Electronic Data Capture (REDCap) system. The sequence is inaccessible to the trial investigators. We will conceal the allocation by incorporating the random permuted blocks of size 2 and 4 sequences within the REDCap system.
Masking: Single (Outcomes Assessor)
Masking Description: Blinding of the clinicians, nurses, and patient caregivers are impractical. However, to minimize the bias, we will neither mention the method used to estimate the endotracheal tube insertion depth to the patient caregivers explicitly and nor record in the patient charts. We will blind the primary outcome assessment by masking the consultant pediatric radiologist to the group assignment. Similarly, the consultant pediatric radiologist will determine the following secondary outcomes-endotracheal tube tip above the upper border of T1 vertebra, endotracheal tube tip below the lower border of T2 vertebra, and pneumothorax. The other secondary outcomes (endotracheal tube repositioning after the X-ray, oxygen therapy at 28 days, oxygen therapy, or positive pressure support at 36 weeks post-menstrual age, duration of invasive ventilation, and death before discharge) will be determined by the trained research assistant.
Primary Purpose: Supportive Care
Official Title: Gestational Age Versus Nasal-tragus Length for Estimating Endotracheal Tube Insertion Depth in Newborns - A Randomised Trial
Actual Study Start Date : June 15, 2020
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : December 2023


Arm Intervention/treatment
Experimental: Gestational Age Chart Method
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)
Other: Gestational Age Chart Method
The endotracheal tube insertion depth is obtained by the gestational age chart

Active Comparator: Nasal-Tragus Length Method
In this method, the endotracheal tube insertion depth is calculated based on the formula-the distance from nasal septum tip to ear tragus+1 cm
Other: Nasal-Tragus Length Method
The endotracheal tube insertion depth is obtained by the nasal-tragus method formula




Primary Outcome Measures :
  1. Proportion of infants with optimally positioned endotracheal tube tip on the chest X-ray [ Time Frame: within 4 hours of endotracheal intubation ]
    Endotracheal tube tip is considered optimally positioned if the tip lies between upper border of first thoracic vertebra (T1) and the lower border of second thoracic vertebra (T2) on the chest X-ray. While obtaining the antero-posterior view chest X-ray in supine position, the infant's head, neck and chest is placed in the midline with no tension on the endotracheal tube and neck being in neutral position (i.e. neck neither flexed nor extended). Just before obtaining the film, the investigator/research assistant should re-confirm that the endotracheal tube is secured in a standardize manner at the estimated depth based on the treatment arm assigned.


Secondary Outcome Measures :
  1. Proportion of infants with endotracheal tube tip above T1 vertebra [ Time Frame: within 4 hours of endotracheal intubation ]
    Presence of endotracheal tube tip above the upper border of first thoracic vertebra e of endotracheal tube tip below the lower border of second thoracic vertebra on the chest X-ray

  2. Proportion of infants with endotracheal tube tip below T2 vertebra [ Time Frame: within 4 hours of endotracheal intubation ]
    Presence of endotracheal tube tip below the lower border of second thoracic vertebra on the chest X-ray

  3. Proportion of infants with pneumothorax [ Time Frame: 36 weeks of post-menstrual age ]
    Presence of air in the pleural space determined by a chest X-ray

  4. Proportion of infants with requiring endotracheal tube repositioning (advance or withdrawn) following chest X-ray [ Time Frame: 24 hours ]
    Repositioning of the endotracheal tube will be done based on attendings discretion

  5. Proportion of infants with oxygen therapy [ Time Frame: 28 days from the birth ]
    Any supplemental oxygen (>21%) on invasive or non-invasive respiratory support

  6. Proportion of infants with bronchopulmonary dysplasia [ Time Frame: 36 weeks of post-menstrual age ]
    It is defined as oxygen therapy or positive pressure support (include nasal cannula <2 liter/minute and >30% oxygen, nasal cannula >2 liters/minute and any oxygen, continuous positive airway pressure and any oxygen, or invasive respiratory support and any oxygen)

  7. Ventilation days [ Time Frame: 36 weeks of post-menstrual age ]
    Duration of invasive ventilation

  8. Proportion of infants with mortality [ Time Frame: 36 weeks of post-menstrual age ]
    Death occurring anytime from birth until discharge



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04393337


Locations
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Saudi Arabia
King Fahad Hospital, AlBaha University Recruiting
Al Bahah, Saudi Arabia
Contact: Jameel Alghamdi    00966555770733    dr.jameelalghamdi@hotmail.com   
King Abdullah bin Abdulaziz University Hospital Recruiting
Riyadh, Saudi Arabia, 13412
Contact: Abdul Razak, MD    0118200000 ext 3526    aarazak@kaauh.edu.sa   
Principal Investigator: Abdul Razak, MD         
King Faisal Specialist Hospital & Research Centre Recruiting
Riyadh, Saudi Arabia
Contact: Abdulaziz Binmanee    00966565454292    zizmaze@hotmail.com   
Sponsors and Collaborators
Princess Nourah Bint Abdulrahman University
King Fahad Hospital
King Faisal Specialist Hospital & Research Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Abdul Razak, Clinical Assistant Professor, Princess Nourah Bint Abdulrahman University
ClinicalTrials.gov Identifier: NCT04393337    
Other Study ID Numbers: 20-0148
First Posted: May 19, 2020    Key Record Dates
Last Update Posted: October 25, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bronchopulmonary Dysplasia
Pneumothorax
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Pleural Diseases