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

NCT04393337 | Unknown DMC

• 1 other identifier: 20-0148
• Study Type: interventional
• Target: 454
• Locations: 1 country
• Sites: 3

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.

Conditions

Endotracheal Tube Tip Position; Bronchopulmonary Dysplasia; Pneumothorax; Death; Duration, Ventilator

Outcome Measures

Primary Outcomes (1)

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

  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.

  within 4 hours of endotracheal intubation

Secondary Outcomes (8)

• Proportion of infants with endotracheal tube tip above T1 vertebra

  within 4 hours of endotracheal intubation

• Proportion of infants with endotracheal tube tip below T2 vertebra

  within 4 hours of endotracheal intubation

• Proportion of infants with pneumothorax

  36 weeks of post-menstrual age

• Proportion of infants with requiring endotracheal tube repositioning (advance or withdrawn) following chest X-ray

  24 hours

• Proportion of infants with oxygen therapy

  28 days from the birth

Study Arms (2)

Gestational Age Chart Method

EXPERIMENTAL

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

Nasal-Tragus Length Method

ACTIVE COMPARATOR

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

Interventions

Gestational Age Chart Method OTHER

The endotracheal tube insertion depth is obtained by the gestational age chart

Gestational Age Chart Method

Nasal-Tragus Length Method OTHER

The endotracheal tube insertion depth is obtained by the nasal-tragus method formula

Nasal-Tragus Length Method

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Princess Nourah Bint Abdulrahman University: lead
• King Fahad Hospital: collaborator
• King Faisal Specialist Hospital & Research Center: collaborator

Study Sites (3)

King Fahad Hospital, AlBaha University

Al Bahah, Saudi Arabia

RECRUITING

King Abdullah bin Abdulaziz University Hospital

Riyadh, 13412, Saudi Arabia

RECRUITING

King Faisal Specialist Hospital & Research Centre

Riyadh, Saudi Arabia

RECRUITING

Related Publications (1)

• Razak A, Faden M, Alghamdi J, Binmanee A, Alonazi AH, Hamdoun A, Almugaiteeb S, Patel W, Katar H, Lora F, Alismail A, Lavery A, Hamama I, Alsaleem N, Alshaikh M, Alrasheed L, Aldibasi O. Randomised trial estimating length of endotracheal tube insertion using gestational age or nasal-tragus length in newborns: a study protocol. BMJ Open. 2022 Jan 19;12(1):e055628. doi: 10.1136/bmjopen-2021-055628.

  PMID: 35046004 DERIVED

MeSH Terms

Conditions

Bronchopulmonary Dysplasia; Pneumothorax; Death

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pleural Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: May 19, 2020
• Study Start: June 15, 2020
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: October 25, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

SA (3)