Effectiveness of using high versus low fidelity manikins to improve the technical skills of pediatric residents in neonatal intubation
| ISRCTN | ISRCTN16251230 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16251230 |
| Secondary identifying numbers | (HA-02-J-008) |
- Submission date
- 15/02/2018
- Registration date
- 21/03/2018
- Last edited
- 16/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
About 10% of newborns require some assistance to begin breathing at birth, and about 1% need extensive resuscitative measures to survive. Optimal care provided during the first few minutes of life plays a major role in reducing morbidity (illness) and mortality (death). Therefore, the Accreditation Council for Graduate Medical Education (ACGME) currently mandates the completion of formal training, via the neonatal resuscitation program (NRP), by all pediatric residents. The term ‘fidelity’ is generally used to refer to the degree of realism of a simulation. Low-fidelity simulator (LFS) mannequins allow practitioners to demonstrate basic knowledge and technical and behavioral skills with verbal prompts from the instructors. High-fidelity simulators (HFS) provide the trainee with the cues necessary to interact with the patient as they would in the real clinical environment. However, there are few studies describing the use of HFS in teaching neonatal resuscitation. The aim of this study is to inform the supporting and financing bodies as to whether selecting a training method that is more costly (HFS) is justified by a better outcome of improving pediatric trainees’ neonatal intubation skills and retention of these skills towards enhanced patient care.
Who can participate?
Pediatric residents in their first year of postgraduate training in pediatrics recruited from two hospitals (KAUH and MCH) in Jeddah, Kingdom of Saudi Arabia
What does the study involve?
Participants first receive a lecture reminding them of the basic anatomy of the neonatal airway and the steps required for intubating a newborn (inserting a breathing tube). Participants are then randomly allocated to use either high fidelity or low fidelity mannequins for the training of intubation. Participants are then evaluated on the same day of the training course on their newborn intubation skills and again 9-12 months after the training course.
What are the possible benefits and risks of participating?
Participants receive training on mannequins to improve their newborn intubation skills. There are no risks for the participants.
Where is the study run from?
King Abdulaziz University Hospital (Saudi Arabia)
When is the study starting and how long is it expected to run for?
October 2017 to April 2018
Who is funding the study?
King Abdulaziz University (Saudi Arabia)
Who is the main contact?
Dr Heidi Al-Wassia
halwassia@kau.edu.sa
Contact information
Scientific
King Abdulaziz University
Department of Pediatrics
Jeddah
80215
Saudi Arabia
| Phone | +966 (0)12 6401000 ext 20208 |
|---|---|
| halwassia@kau.edu.sa |
Study information
| Study design | Randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | The effect of high versus low fidelity simulators on the acquisition and retention of technical skills necessary for neonatal intubation by pediatric residents: a randomized trial |
| Study objectives | Null hypothesis: There is no difference in junior pediatric residents’ technical skills needed to intubate a neonate as a function of training modality: high-fidelity or low-fidelity simulation. Alternate hypothesis: Training pediatric residents on high fidelity mannequins will result in improved pediatric residents’ skills required to intubate a neonate compared to low fidelity mannequins. |
| Ethics approval(s) | Unit of Biomedical Ethics Research Committee, 28/12/2016, ref: 471-16 |
| Health condition(s) or problem(s) studied | Intubation of neonates |
| Intervention | This is a randomized non-blinded trial where pediatric residents will be randomly allocated to either a training course to teach technical skills of intubating a newborn using a high fidelity or low fidelity mannequin simulator. For randomization, the trialists will use computer-generated random numbers. The randomization allocation cards will be placed in serially numbered, opaque, sealed envelopes. The trialists will ask all residents in King Abdul-Aziz University Hospital (KAUH) and Maternity and Children Hospital (MCH) to participate after signing a consent form. Pediatric residents from the two centers will first be assessed at baseline using high fidelity simulator where they will manage a standardized simulated scenario of a neonate requiring intubation. After recruitment subjects will be randomly assigned to training on either a high fidelity or low fidelity simulator. A training course will be designed to improve the intubation skills of pediatric residents at KAUH and MCH using the assigned simulators. The high fidelity mannequin (SimBaby, Laerdal Medical Corporation, USA) is an advanced infant patient simulator with realistic airway anatomy and clinical functionality. It features airway opening by appropriate maneuvers, suctioning suction motion, anatomical landmarks of oropharyngeal and nasopharyngeal airways, and chest rise and oxygen saturation. It utilizes software-based medical models, allowing the instructor to focus on interacting with learners rather than operating the simulator. The low fidelity mannequin is a standard plastic mannequin (ALS Baby, Laerdal Medical Corporation, USA) that allows passing ET tube and demonstrates chest rises in response to successful intubation. It does not, however, feature anatomical landmarks of the neonatal airway or give physiological cues such as oxygen saturation, heart rate and changes in CO2 detector color. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | Effectiveness of using HFS compared to LFS in improving the technical skills in intubating a neonate, measured by the successful passage of endotracheal tube beyond the vocal cord after the training course and 9-12 months after |
| Secondary outcome measures | 1. Time taken to intubate is measured using stopwatch seconds at baseline, after the training course and 9-12 months after 2. Correct placement of the tube in a neonate is measured using a validated 13-item checklist score at baseline, after the training course and 9-12 months after |
| Overall study start date | 01/10/2017 |
| Completion date | 01/04/2018 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 17 residents from KAUH and 20 from MCH |
| Key inclusion criteria | 1. Pediatric residents in their first year of postgraduate training in pediatrics recruited from two hospitals (KAUH and MCH) in Jeddah, Kingdom of Saudi Arabia 2. Both male and female residents |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/06/2017 |
| Date of final enrolment | 01/10/2017 |
Locations
Countries of recruitment
- Saudi Arabia
Study participating centre
PO Box 80215
Jeddah
21589
Saudi Arabia
Sponsor information
University/education
PO Box 80200
Jeddah
21589
Saudi Arabia
"ROR" |
https://ror.org/02ma4wv74 |
|---|
Funders
Funder type
University/education
Government organisation / Local government
- Alternative name(s)
- جامعة الملك عبدالعزيز, L'université du Roi Abdulaziz, La Universidad Rey Abdulaziz, King Abdulaziz University of Saudi Arabia, KAU
- Location
- Saudi Arabia
Results and Publications
| Intention to publish date | 01/12/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The results of the trial will be submitted to either neonatology journals or medical education journals as soon as they are ready for publication. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Heidi Al-Wassia (halwassia@kau.edu.sa). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 25/06/2022 | 16/08/2022 | Yes | No |
Editorial Notes
16/08/2022: Publication reference added.
12/03/2020: The intention to publish date was changed from 01/09/2019 to 01/12/2020.
25/04/2019: The intention to publish date was changed from 01/09/2018 to 01/09/2019.
