An observational study in Point of Care Ultrasound, sponsored by Aga Khan University. Status unknown at 1 site in Pakistan. Open to participants aged 1 Minute to 28 Days. Per ClinicalTrials.gov, last updated 2018-07-05.
Sponsored by Aga Khan University · Observational
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.
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).
Aga Khan University is the lead sponsor of 290 studies on the registry; 44 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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
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).
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.
Time frame: 4 months
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.
Time frame: 12 months
Plan to share: No
This study is status unknown, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Aga Khan University