A Novel Training Simulator for Portable Ultrasound Identification of Incorrect Newborn Endotracheal Tube Placement

NCT03533218 | Unknown DMC

• 1 other identifier: POCUS
• Study Type: observational
• Target: 292
• Locations: 1 country
• Sites: 1

Brief Summary

First seconds after birth, new born baby go through physiologic changes to successfully adjust to the external environment specially establishment of independent respiration. Majority of the organ systems adaptation in newborns occur gradually, but radical and rapid cardiopulmonary adaptation must occur for neonates to survive. It is during this period that approximately 10% neonates require some level of support in the form of resuscitation. A knowledgeable, quick and skillful response by all caregivers is crucial for extra uterine survival. Tracheal intubation is performed frequently in the Neonatal Intensive Care Units (NICU) and delivery rooms. Neonatal intubation is a critical and time-sensitive procedure, and failure deprives the sickest newborns of oxygen. Current methods to detect a misplaced esophageal ETT in newborns are suboptimal. Physical examination findings are often unreliable, exhaled carbon-dioxide testing is often unavailable outside of resource-rich facilities and can lead to false positive results ,while chest radiographs are not only time consuming ,labor intensive but also expose vulnerable newborn babies to significant radiation However portable ultrasound machines are relatively available even in small centers mostly being used in the maternity units, being an indispensable tool for managing obstetrics, gynecology and trauma cases. POCUS methods of assessing ETT position offer an alternative that is time saving, cheap and safe, thereby of critical importance in the neonatal "time-is-brain" scenario. Our project aims to demonstrate that POCUS can effectively and accurately detect esophageal intubations, and in shorter period of time than current standard-of-care methods that are colorimetric end- tidal carbon-dioxide (CO2) detector and chest x-ray.

Conditions

Point of Care Ultrasound

Keywords

endotracheal tube, point of care ultrasound

Outcome Measures

Primary Outcomes (1)

• training of health care workers

  To determine if neonatal providers trained in ETT location with the simulator will detect correct ETT placement with \>95% accuracy immediately and after validation of their skills.

  4 months

Secondary Outcomes (1)

• comparison with standard methods

  12 months

Interventions

Point of care Ultrasound machine DEVICE

POCUS methods of assessing ETT location offer an alternative that is time saving and thereby of critical importance in the neonatal "time-is-brain" scenario. Recently the government of Pakistan began upgrading health facilities and ensuring placement of essential equipment required to provide competent medical care, which may include provision of ultrasound machines to areas where there is established benefits to their use. Presence of trained staff and provision of portable ultrasound machine with short start-up time can save newborn lives(12).POCUS method empowers health care providers to read and interpret images in real time thereby saving critical time and need for specialized human resources (radiologists).

Eligibility Criteria

• Age: 1 Minute - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

phase I health care workers who currently perform standard-of-care ETT location assessment in the delivery room or NICU. phase II all newborns require intubation in labor and delivery room or in NICU.

You may not qualify if:

• Providers who are not involved in newborn resuscitation and assessing ETT location using standard methods
• \- Newborns with any congenital syndromes affecting the oropharynx or airway anatomy.

Sponsors & Collaborators

• Aga Khan University: lead
• The Hospital for Sick Children: collaborator
• Grand Challenges Canada: collaborator

Study Sites (1)

Aga Khan University

Karachi, Sindh, 74800, Pakistan

Location

Related Publications (19)

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  BACKGROUND

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  BACKGROUND

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  BACKGROUND

• Chou EH, Dickman E, Tsou PY, Tessaro M, Tsai YM, Ma MH, Lee CC, Marshall J. Ultrasonography for confirmation of endotracheal tube placement: a systematic review and meta-analysis. Resuscitation. 2015 May;90:97-103. doi: 10.1016/j.resuscitation.2015.02.013. Epub 2015 Feb 21.

  PMID: 25711517 BACKGROUND

• Ali KQ, Soofi SB, Hussain AS, Ansari U, Morris S, Tessaro MO, Ariff S, Merali H. Simulator-based ultrasound training for identification of endotracheal tube placement in a neonatal intensive care unit using point of care ultrasound. BMC Med Educ. 2020 Nov 7;20(1):409. doi: 10.1186/s12909-020-02338-4.

  PMID: 33160342 DERIVED

• Merali HS, Tessaro MO, Ali KQ, Morris SK, Soofi SB, Ariff S. A novel training simulator for portable ultrasound identification of incorrect newborn endotracheal tube placement - observational diagnostic accuracy study protocol. BMC Pediatr. 2019 Nov 13;19(1):434. doi: 10.1186/s12887-019-1717-y.

  PMID: 31722685 DERIVED

Study Officials

• Shabina Ariff, MBBS, FCPS

  Aga Khan University

  PRINCIPAL INVESTIGATOR

• Mark Tessaro, MD, FRCPC

  The Hospital for Sick Kids

  STUDY CHAIR

• Khushboo Qaim, BScN

  Aga Khan University

  STUDY DIRECTOR

• Hasan Meerali, MD, FAAP

  The Hospital for Sick Kids

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 10, 2018
• First Posted: May 23, 2018
• Study Start: June 1, 2018
• Primary Completion: October 1, 2019
• Study Completion: December 1, 2019
• Last Updated: July 5, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)