Scoring instrument for breathing tube insertion in newborn babies
| ISRCTN | ISRCTN47516971 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47516971 |
- Submission date
- 29/11/2019
- Registration date
- 03/12/2019
- Last edited
- 03/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English Summary
Background and study aims
Neonatal intubation is a complex life-saving skill to treat respiratory failure that is not used often but clinicians need to be sufficiently skilled to perform it well. Many professionals are insufficiently skilled and may inflict harm while performing the procedure. Frequent training and clinical exposure are necessary to maintain neonatal intubation competence and to ensure greater success, shorter duration, and less complications. The researchers have previously developed a reliable and practical instrument for video-based assessment of neonatal intubations. The instrument’s construct validity and real-time applicability remained to be determined. Therefore, this study’s objectives were to
1. Establish the construct validity of our scoring instrument, using an extreme groups approach and the hypothesis that targeted feedback leads to improved intubation skills
2. Determine whether our tool can be reliably employed for real-time assessment of neonatal intubation skills
Who can participate?
Healthcare professionals, affiliated with Lucile Packard Children’s Hospital and frequently involved in neonatal intubation, participated as ‘experts’. First to fourth-year medical students from Stanford University School of Medicine, lacking (neonatal) intubation experience, participated as ‘novices’
What does the study involve?
Participants had to perform two intubations on a newborn manikin. All subjects were divided over two groups: one that received feedback on their performance in between the two intubations and one that did not receive feedback. The scoring instrument was used to rate the intubation, both in real time and on video.
If the scoring instrument is valid, the feedback group will have a higher score after feedback. Also, the experienced clinicians would have higher scores than the students. If the scoring instrument is reliable across real time and video assessment, then the scores will be similar in both domains.
What are the possible benefits and risks of participating?
There were no particular risks associated with participation in this study. A potential advantage might be that subjects had the opportunity for extra training in neonatal intubation in a simulated setting. Especially the subjects in the intervention group may have benefited from the feedback they received on their intubation performance.
Where is the study run from?
The study was conducted at the Center for Advanced Pediatric and Perinatal Education (CAPE), Stanford University, Palo Alto, USA
When is the study starting and how long is it expected to run for?
January 2018 to April 2018
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Mathijs Binkhorst
mathijs.binkhorst@radboudumc.nl
Contact information
Scientific
Radboud UMC
Geert grooteplein zuid 10
Nijmegen
6525 AM
Netherlands
 ORCID ID |
0000-0002-5824-6121 |
|---|---|
| Phone | +31 243613860 |
| mathijs.binkhorst@radboudumc.nl |
Study information
| Study design | Interventional randomised 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 below to request a patient information sheet |
| Scientific title | Validation of an instrument for real-time assessment of neonatal intubation skills: a randomised controlled simulation study |
| Study hypothesis | The construct validity of a previously developed neonatal intubation scoring instrument can be established by showing that more experienced clinicians have higher scores than medical students and by demonstrating that structured feedback improves intubation scores. We also try to prove the reliability of real-time assessment with our assessment instrument. |
| Ethics approval(s) | Approved 26/01/2018, Institutional review board of Stanford University (1705 El Camino Real, Palo Alto, CA 94306, USA; irbeducation@stanford.edu; +1 (650) 724-7141), ref: 44321 |
| Condition | Simulation-based skills training |
| Intervention | Clinicians and medical students are randomly assigned to either the intervention group, receiving feedback before they perform a second simulated neonatal intubation or the control group, receiving no feedback between first and second intubation. The correlation between intubation experience and intubation score is determined. Also, the interrater reliability of real-time assessment compared with assessment on video is determined. Subjects in the intervention group received a form with predefined feedback regarding every item of the scoring instrument, which was structured in accordance with performance metrics taken from The Textbook of Neonatal Resuscitation, 7th Edition. Feedback specific to the errors made during the first intubation was highlighted on the form. The principal investigator gave this feedback form to the subjects. All subjects provided their background characteristics, including four characteristics that indicated their neonatal intubation experience: NICU experience (years), number of previous successful neonatal intubations, number of previous simulated neonatal intubations, and most recent successful neonatal intubation. Each characteristic was assigned 0 to 5 points. Composite experience scores were calculated for all subjects by the principal investigator. Zero points represented no experience, twenty points represented high experience. We were unable to identify another useful, validated measure of neonatal intubation experience in the literature. Therefore, we used this experience score, which was based on consensus among various neonatal intubation experts, and also used in the prequel of this study. Intubation score was measured by the principal investigator using the neonatal intubation scoring instrument (NISI) (i.e. the instrument being validated in this study) Randomisation: Simple, stratified, computer based randomisation. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Construct validity was assessed by: 1.1. Determining the correlation, analysed with Spearman’s rank-order correlation test, between intubation experience and intubation score, measured with the scoring systems mentioned above. Intubation experience was measured just prior to the simulation, intubation score was measured during the simulated intubation 1.2. Evaluating the effect of feedback on intubation performance; to this end, we compared the intervention group to the control group regarding the difference in intubation scores between the first and second intubation. 2. Reliability of real-time assessment assessed by: the intra-rater reliability, expressed as Intraclass correlation coefficient, of the intubation scores obtained using real-time assessment and the intubation scores obtained using video-based assessment. |
| Secondary outcome measures | None. |
| Overall study start date | 01/09/2017 |
| Overall study end date | 30/04/2018 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 36 |
| Total final enrolment | 35 |
| Participant inclusion criteria | 1. Clinicians experienced in neonatal intubation 2. Medical students lacking intubation experience |
| Participant exclusion criteria | Clinicians with intermediate intubation experience |
| Recruitment start date | 26/01/2018 |
| Recruitment end date | 30/03/2018 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Palo alto
CA 94304
United States of America
Sponsor information
Hospital/treatment centre
Geert grooteplein zuid 10
Nijmegen
6525 AM
Netherlands
| Phone | +31 243611111 |
|---|---|
| amaliakinderziekenhuis@radboudumc.nl | |
| Website | http://www.radboudumc.nl |
"ROR" |
https://ror.org/05wg1m734 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/01/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Publication in peer reviewed medical journal on pediatrics/neonatology. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 08/09/2020 | 03/09/2021 | Yes | No |
Editorial Notes
03/09/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
03/12/2019: Trial’s existence confirmed by Stanford University
