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

July 3, 2018 updated by: Dr Shabina Ariff, Aga Khan University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Phase 1 would entirely base on training of all newborn care providers. The training phase of the study includes two stages:

Stage 1: It will involve training of new born care providers in detecting esophageal versus tracheal intubations using the ultrasound simulator, and then ensure they are able to accurately detect this difference using our evaluation tools.

Experts in POCUS will train neonatal health care providers at Aku.

Stage 2 : It would comprise of validation and assessment of POCUS competency. For this purpose neonatal health care providers that underwent training will perform Ultrasound of intubated babies who are hemodynamically stable in NICU, captured images and save them.

These images will be interpreted in real time by the trainee and validate by trained PI. 10% images will be sent to Sick Kids POCUS trainer for revalidation. Health care provider will validate at least 10 images correctly to be certified as successfully trained and move to Phase 2.

Phase 2. New-born at The Aga Khan Hospital who requires intubation will be assessed for ETT placement via ultrasound and simultaneously with the standard methods. The time required to assess a correct endotracheal intubation will be compared between POCUS and standard care methods that are colorimetric end- tidal carbon-dioxide (CO2) detector.

Study population and sample size:

Phase 1: The training session will be provided to health care providers who attend deliveries and exclusively involved in newborn care, which include Neonatal attending, postgraduate trainees, neonatal fellows and nursing staffs.

The POCUS will be done by Fellows, attending and Senior Staff only.

Phase 2: A Sample size of 292 newborn will be recruited considering these assumptions that in the Aga khan university, Hospital Karachi currently has approximately 5,000 deliveries per year and 600 infants per year require admission in the NICU (12% of total NICU admissions).

Study Type

Observational

Enrollment (Anticipated)

292

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 74800
        • Aga Khan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 minute to 4 weeks (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

phase I

Inclusion Criteria All healthcare workers who are involved in assessing ETT location in newborns after intubation using standard methods at AKUH

Exclusion Criteria

-Providers who are not involved in newborn resuscitation and assessing ETT location using standard methods

phase II Inclusion Criteria - All newborns needing intubation in the delivery room or in the NICU

Exclusion Criteria

- Newborns with any congenital syndromes affecting the oropharynx or airway anatomy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
training of health care workers
Time Frame: 4 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
comparison with standard methods
Time Frame: 12 months
To determine the time to detect ETT location is less for POCUS than for colorimetric end- tidal carbon-dioxide (CO2) detector and chest radiograph.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aga Khan University

Collaborators

The Hospital for Sick Children
Grand Challenges Canada

Investigators

  • Principal Investigator: Shabina Ariff, MBBS, FCPS, Aga Khan University
  • Study Chair: Mark Tessaro, MD, FRCPC, The Hospital for Sick Kids
  • Study Director: Khushboo Qaim, BScN, The Aga Khan University
  • Study Director: Hasan Meerali, MD, FAAP, The Hospital for Sick Kids

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2018

Primary Completion (ANTICIPATED)

October 1, 2019

Study Completion (ANTICIPATED)

December 1, 2019

Study Registration Dates

First Submitted

May 10, 2018

First Submitted That Met QC Criteria

May 10, 2018

First Posted (ACTUAL)

May 23, 2018

Study Record Updates

Last Update Posted (ACTUAL)

July 5, 2018

Last Update Submitted That Met QC Criteria

July 3, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • POCUS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Point of Care Ultrasound

Clinical Trials on Point of care Ultrasound machine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Finland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe