Point of Care UltrasoundNCT03533218
A Novel Training Simulator for Portable Ultrasound Identification of Incorrect Newborn Endotracheal Tube Placement
An observational study of Point of Care Ultrasound, run by Aga Khan University at 1 site in Pakistan.
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… Read more about this study
- Who is it for?
- Ages 1 minute to 28 days
- Conditions the study is for
- Point of Care Ultrasound
- What is being tested?
- Point of care Ultrasound machine
- Type of treatment
- Medical device
- How many people
- 292 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2018to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 28 days
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
None listed.
Who cannot join
- -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
- Newborns with any congenital syndromes affecting the oropharynx or airway anatomy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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).
- Conditions
- Point of Care Ultrasound
- Being tested
- Point of care Ultrasound machine
- Keywords
- endotracheal tube, point of care ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point of care Ultrasound machineDevice
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).
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Secondary outcomes (1)
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start1 Jun 2018
- Primary completionOct 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Point of Care UltrasoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 292 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- The Hospital for Sick Children, Grand Challenges Canada
- Responsible party
- Principal investigator, Dr Shabina Ariff, Aga Khan University
- Investigators
- Shabina Ariff, MBBS, FCPS, Principal investigator, Aga Khan UniversityMark Tessaro, MD, FRCPC, Study chair, The Hospital for Sick KidsKhushboo Qaim, BScN, Study director, Aga Khan UniversityHasan Meerali, MD, FAAP, Study director, The Hospital for Sick Kids
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03533218
- Sponsor's protocol ID
- POCUS
- Status last verified
- Jul 2018
- First submitted
- 10 May 2018
- Last updated
- 5 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Askin DF. Complications in the transition from fetal to neonatal life. J Obstet Gynecol Neonatal Nurs. 2002 May-Jun;31(3):318-27. doi: 10.1111/j.1552-6909.2002.tb00054.x.
PubMed 12033545Simpson 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. doi: 10.1016/j.clp.2005.11.015.
PubMed 16533634American 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. No abstract available.
PubMed 18698199Schmolzer 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.
PubMed 24136633Jukkala AM, Henly SJ. Readiness for neonatal resuscitation: measuring knowledge, experience, and comfort level. Appl Nurs Res. 2007 May;20(2):78-85. doi: 10.1016/j.apnr.2006.01.006.
PubMed 17481471Carbajal R, Eble B, Anand KJ. Premedication for tracheal intubation in neonates: confusion or controversy? Semin Perinatol. 2007 Oct;31(5):309-17. doi: 10.1053/j.semperi.2007.07.006.
PubMed 17905186Schmolzer 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.
PubMed 23211476Peterson 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. doi: 10.1038/sj.jp.7211503.
PubMed 16642028Divatia J, Bhowmick K. Complications of endotracheal intubation and other airway management procedures. Indian J Anaesth. 2005;49(4):308-18.
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.
PubMed 23826756Sakhuja 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.
PubMed 26884771Demographic P. Health Survey 2012-13: Islamabad. Pakistan, and Calverton, Maryland USA: National Institute of Population Studies and ICF International. 2013.
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. doi: 10.2471/blt.08.050963.
PubMed 19274365Lawn 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. doi: 10.1016/S0140-6736(05)71048-5.
PubMed 15752534
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Training Simulator for Portable Ultrasound Identification of Incorrect Newborn Endotracheal Tube Placement, Karachi Pakistan
- ClinicalTrials.gov ID
- NCT03533218
- Acronym / sponsor ID
- POCUS
- Conditions
- Point of Care Ultrasound
- Keywords
- endotracheal tube, point of care ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 292 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- The Hospital for Sick Children, Grand Challenges Canada
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 23 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 minute to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- -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
- Newborns with any congenital syndromes affecting the oropharynx or airway anatomy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Point of care Ultrasound machinePOCUS 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). | Device | – |
Primary outcome
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.
1 secondary outcome
comparison with standard methods
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2018.
- Background: PubMed 12033545Askin DF. Complications in the transition from fetal to neonatal life. J Obstet Gynecol Neonatal Nurs. 2002 May-Jun;31(3):318-27. doi: 10.1111/j.1552-6909.2002.tb00054.x.
- BackgroundSimpson K, & Chreehan, P. Newborn adaptation to extrauterine life. Perinatal nursing,. 2nd ed. ed. PA7 Lippincott: Philadelphia; (2001).
- Background: PubMed 16533634Stenson BJ, Boyle DW, Szyld EG. Initial ventilation strategies during newborn resuscitation. Clin Perinatol. 2006 Mar;33(1):65-82, vi-vii. doi: 10.1016/j.clp.2005.11.015.
- Background: PubMed 18698199American 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. No abstract available.
- Background: PubMed 24136633Schmolzer 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.
- Background: PubMed 17481471Jukkala AM, Henly SJ. Readiness for neonatal resuscitation: measuring knowledge, experience, and comfort level. Appl Nurs Res. 2007 May;20(2):78-85. doi: 10.1016/j.apnr.2006.01.006.
- Background: PubMed 17905186Carbajal R, Eble B, Anand KJ. Premedication for tracheal intubation in neonates: confusion or controversy? Semin Perinatol. 2007 Oct;31(5):309-17. doi: 10.1053/j.semperi.2007.07.006.
- Background: PubMed 23211476Schmolzer 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.
- Background: PubMed 16642028Peterson 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. doi: 10.1038/sj.jp.7211503.
- BackgroundDivatia J, Bhowmick K. Complications of endotracheal intubation and other airway management procedures. Indian J Anaesth. 2005;49(4):308-18.
- Background: PubMed 23826756Adi 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.
- Background: PubMed 26884771Sakhuja 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shabina Ariff, MBBS, FCPS principal investigator
Aga Khan University
Mark Tessaro, MD, FRCPC study chair
The Hospital for Sick Kids
Khushboo Qaim, BScN study director
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Point of Care Ultrasound, run by Aga Khan University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
training of health care workers (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03533218, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2018.