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

Point of Care Ultrasound Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03533218
• Other study ID #: POCUS
• Status: Active, not recruiting
• Start date: June 1, 2018
• Est. completion date: December 2019

Study information

• Verified date: July 2018
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 292
• Est. completion date: December 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 28 Days

Eligibility

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.

Related Conditions & MeSH terms

• Point of Care Ultrasound

Intervention

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).

Locations

Country	Name	City	State
Pakistan	Aga Khan University	Karachi	Sindh

Sponsors (3)

Lead Sponsor	Collaborator
Aga Khan University	Grand Challenges Canada, The Hospital for Sick Children

Country where clinical trial is conducted

Pakistan, 

References & Publications (17)

Adi O, Chuan TW, Rishya M. A feasibility study on bedside upper airway ultrasonography compared to waveform capnography for verifying endotracheal tube location after intubation. Crit Ultrasound J. 2013 Jul 4;5(1):7. doi: 10.1186/2036-7902-5-7. — View Citation

Aga Khan University From Wikipedia, the free encyclopedia [07.03.2017].

American Academy of Pediatrics/American Heart Association. American Academy of Pediatrics/American Heart Association clarification of statement on cardiovascular evaluation and monitoring of children and adolescents with heart disease receiving medications for ADHD: May 16, 2008. J Dev Behav Pediatr. 2008 Aug;29(4):335. doi: 10.1097/DBP.0b013e31318185dc14. — View Citation

Askin DF. Complications in the transition from fetal to neonatal life. J Obstet Gynecol Neonatal Nurs. 2002 May-Jun;31(3):318-27. Review. — View Citation

Carbajal R, Eble B, Anand KJ. Premedication for tracheal intubation in neonates: confusion or controversy? Semin Perinatol. 2007 Oct;31(5):309-17. Review. — View Citation

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. Review. — View Citation

Demographic P. Health Survey 2012-13: Islamabad. Pakistan, and Calverton, Maryland USA: National Institute of Population Studies and ICF International. 2013.

Divatia J, Bhowmick K. Complications of endotracheal intubation and other airway management procedures. Indian J Anaesth. 2005;49(4):308-18.

Jehan I, Harris H, Salat S, Zeb A, Mobeen N, Pasha O, McClure EM, Moore J, Wright LL, Goldenberg RL. Neonatal mortality, risk factors and causes: a prospective population-based cohort study in urban Pakistan. Bull World Health Organ. 2009 Feb;87(2):130-8. — View Citation

Jukkala AM, Henly SJ. Readiness for neonatal resuscitation: measuring knowledge, experience, and comfort level. Appl Nurs Res. 2007 May;20(2):78-85. — View Citation

Lawn JE, Cousens S, Zupan J; Lancet Neonatal Survival Steering Team. 4 million neonatal deaths: when? Where? Why? Lancet. 2005 Mar 5-11;365(9462):891-900. — View Citation

Peterson J, Johnson N, Deakins K, Wilson-Costello D, Jelovsek JE, Chatburn R. Accuracy of the 7-8-9 Rule for endotracheal tube placement in the neonate. J Perinatol. 2006 Jun;26(6):333-6. — View Citation

Sakhuja P, Finelli M, Hawes J, Whyte H. Is It Time to Review Guidelines for ETT Positioning in the NICU? SCEPTIC-Survey of Challenges Encountered in Placement of Endotracheal Tubes in Canadian NICUs. Int J Pediatr. 2016;2016:7283179. doi: 10.1155/2016/7283179. Epub 2016 Jan 19. — View Citation

Schmölzer GM, Kumar M, Pichler G, Aziz K, O'Reilly M, Cheung PY. Non-invasive versus invasive respiratory support in preterm infants at birth: systematic review and meta-analysis. BMJ. 2013 Oct 17;347:f5980. doi: 10.1136/bmj.f5980. Review. Erratum in: BMJ. 2014;348:g58. — View Citation

Schmölzer GM, O'Reilly M, Davis PG, Cheung PY, Roehr CC. Confirmation of correct tracheal tube placement in newborn infants. Resuscitation. 2013 Jun;84(6):731-7. doi: 10.1016/j.resuscitation.2012.11.028. Epub 2012 Dec 1. Review. — View Citation

Simpson K, & Chreehan, P. Newborn adaptation to extrauterine life. Perinatal nursing,. 2nd ed. ed. PA7 Lippincott: Philadelphia; (2001).

Stenson BJ, Boyle DW, Szyld EG. Initial ventilation strategies during newborn resuscitation. Clin Perinatol. 2006 Mar;33(1):65-82, vi-vii. Review. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	comparison with standard methods	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