Clinical trial NCT03533218: A Novel Training Simulator for Portable Ultrasound Identification of Incorrect Newborn Endotracheal Tube Placement
Official title: A Novel Training Simulator for Portable Ultrasound Identification of Incorrect Newborn Endotracheal Tube Placement, Karachi Pakistan
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Point of Care Ultrasound
Keywords: endotracheal tube, point of care ultrasound
Lead sponsor: Aga Khan University
Sponsor class: OTHER
Collaborators: name: The Hospital for Sick Children
name: Grand Challenges Canada
First posted: 2018-05-23
Enrollment: 292
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: training of health care workers
timeFrame: 4 months
Secondary outcomes:
measure: comparison with standard methods
timeFrame: 12 months
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University
state: Sindh
Study officials:
affiliation: Aga Khan University
name: Shabina Ariff, MBBS, FCPS
role: PRINCIPAL_INVESTIGATOR
affiliation: The Hospital for Sick Kids
name: Mark Tessaro, MD, FRCPC
role: STUDY_CHAIR
affiliation: Aga Khan University
name: Khushboo Qaim, BScN
role: STUDY_DIRECTOR
affiliation: The Hospital for Sick Kids
name: Hasan Meerali, MD, FAAP
role: STUDY_DIRECTOR
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