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Clinical Trials/CTRI/2024/10/075443
CTRI/2024/10/075443Not yet recruitingNot Applicable

Association of Oro-tracheal tube inserted depth with anatomi-cal parameters among infants

Jawaharlal institute of post graduate medical education and research1 site in 1 country200 target enrollmentStarted: October 25, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
200
Locations
1
Primary Endpoint
To measure the inserted depth of ET tube, nasotragal length, sternal length, foot length, thyromental length and manubriosternal junction to mental length and find out appropriate formulae for estimating the insertion depth of endotracheal tube using those parameters.

Study Overview

Brief Summary

:  Endotracheal intubation is a common procedure done in infants and neonates requiring respiratory support. More often this procedure is done in emergency setting, where predicting data such as weight of the patient may not be easy. After intubation, it is a standard medical practice to confirm the clinically effective position of the tip of the ET tube initially by chest auscultation and later by EtCO2. Optimal Endotracheal (ET) tube positioning is important, and the ideal position is halfway between vocal cord and carina. If an ET tube is placed too high accidental extubation may occur, if placed too low then endobronchial intubation, poor ventilation, atelectasis or pneumothorax may occur. The initial clinical assessment of the appropriate intubation depth is to auscultate equal  air entry to the bilateral lungs. Nevertheless, it lacks a quantitative or qualitative change of breathing sound detected on auscultation, despite 1cm downward displacement of the ET tube tip into the main bronchus; one study indicated that up to 60% of endobronchial intubations were by equal breath sound auscultation. Thus, several methods have been reported to determine the proper ET tube depth for  intubation and the accurate ET tube tip position, such as the well-known 7-8-9 Rule, body parameters as a predictor, the manufacturer’s markings on the tube tip and sonogram. Also, a number of nomograms are available to predict this depth from external body measurements such as weight, head circumference, crown-heel or crown-rump length. However, many of these studies have their limitations.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
1.00 Day(s) to 1.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Neonates and infants who undergoes an elective / emergency orotracheal intubation with tip of the ET tube in clinically effective position based on ET tube depth marker at the level of glottis.

Exclusion Criteria

  • Infants with congenital anomalies of head and neck that complicate the ET tube intubation procedure are excluded.

Outcomes

Primary Outcomes

To measure the inserted depth of ET tube, nasotragal length, sternal length, foot length, thyromental length and manubriosternal junction to mental length and find out appropriate formulae for estimating the insertion depth of endotracheal tube using those parameters.

Time Frame: 30 minutes to 1 hour

Secondary Outcomes

  • to develop a regression model to predict ET tube insertional depth using the anatomical parameters(at the time of intubation)

Investigators

Sponsor
Jawaharlal institute of post graduate medical education and research
Sponsor Class
Research institution and hospital
Responsible Party
Principal Investigator
Principal Investigator

Pappu Kumar Mahato

Jawaharlal Institute of Postgraduate Medical Education and Research

Study Sites (1)

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