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

NCT03533218 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 292

Last updated 2018-07-05

No results posted yet for this study

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

Interventions

DEVICE

Point of care Ultrasound machine

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).

Sponsors & Collaborators

  • The Hospital for Sick Children

    collaborator OTHER
  • Grand Challenges Canada

    collaborator OTHER
  • Aga Khan University

    lead OTHER

Principal Investigators

  • Shabina Ariff, MBBS, FCPS · Aga Khan University

  • Mark Tessaro, MD, FRCPC · The Hospital for Sick Kids

  • Khushboo Qaim, BScN · Aga Khan University

  • Hasan Meerali, MD, FAAP · The Hospital for Sick Kids

Eligibility

Min Age
1 Minute
Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2019-10-31
Completion
2019-12-31

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03533218 on ClinicalTrials.gov