PrematurityNCT04521725
Effect of Monitoring Devices on Healthcare Provider Performance During Neonatal Resuscitation
A study testing Respiratory Function Monitor (RFM) and Cerebral Near-Infrared Spectroscopy (NIRS) in people with Prematurity, run by University of Alberta at 1 site in Canada.
Trial summary
Babies born very early (at less than 32 weeks) usually need help to breath right at birth, also called neonatal resuscitation. Healthcare providers (HCPs) are specially trained to provide this help. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Prematurity
- What is being tested?
- Respiratory Function Monitor (RFM) and Cerebral Near-Infrared Spectroscopy (NIRS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteCanada
- Study dates
- 5 Oct 2020to 18 Nov 2021
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- HCPs participating in resuscitations of very preterm infants (23+0-31+6 weeks) at the Royal Alexandra Hospital Neonatal Intensive Care Unit (NICU), a Level III NICU will be included.
- Multiple gestations will be analyzed individually as separate resuscitations. HCPs will include different levels of experience and different disciplines (registered nurses, advance practice nurses, respiratory therapists, neonatal nurse practitioners, pediatric residents, neonatal fellows, clinical associates, and neonatal consultants).
- All HCPs who participate in the resuscitation, regardless of role, will be eligible for completion of NASA-TLX surveys.
- Participants who act as team leader will be eligible to be fitted with eye-tracking glasses to record their visual attention and Empatica E4 wristbands to measure physiological stress measurements.
- For resuscitated infants, hospital outcomes will be included with parental consent.
Who cannot join
- Teams involved in the resuscitation of infants born with congenital malformations, or involved in the care of infants for whom active resuscitation is not planned (i.e., comfort care only for periviable gestations) will be excluded.
- Teams who do not consent to participate will also be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Additional Monitoring Devices on Healthcare Provider Mental Workload, Visual Attention, and Performance During Neonatal Resuscitation
Babies born very early (at less than 32 weeks) usually need help to breath right at birth, also called neonatal resuscitation. Healthcare providers (HCPs) are specially trained to provide this help. HCPs uses information about the baby's condition, such heart rate and oxygen levels, to decide whether they giving the baby effective help, or whether other actions are needed. It can be very stressful for even experienced HCPs to interpret all this data, coordinate a team, make decisions, and perform specialized skills all at the same time.
More recently, new ways of monitoring how a baby is doing neonatal resuscitation has been studied. Respiratory function monitoring (RFM) is a machine that can measure how much air is going into the lungs. This is important as too much air can lead to lung damage, while too little air means that the baby isn't breathing effectively. Another measure is called cerebral near-infrared spectroscopy (cNIRS), which measures oxygen levels in the brain using a probe placed on the forehead. Providing the right amount of oxygen to the most vulnerable organ - the brain - can be important in lowering the risk for injuries to the brain such as brain bleeding. While these machines give us more information, it can also make it even harder for HCPs to focus on the task, adding more complexity to making decisions, adding to their workload, and causing more stress.
To study the effect RFM and cNIRS may have on how affects HCPs workload and stress, the investigators will study HCPs self-reported workload during three time periods - first, doing resuscitations only using basic information (Group 1: heart rate, oxygen levels, direct observations of the baby), second, adding RFM (Group 2), finally adding both RFM and cNIRS (Group 3). A survey called NASA Task Load Index will be used to study HCPs workload. On a small number of teams, the investigators will also track where the leader of the team is looking using eye-tracking glasses, how stressed the leader is by measuring their heart rate, skin sweat, and pupil dilation. Finally, the investigators will collect some information about the baby's resuscitation and hospital stay.
Read the detailed description
The investigators aim to study 93 resuscitations of very preterm infants (23+0-31+6 weeks), in consecutive groups of 31. First, as a baseline, 31 infants will be resuscitated using the standard approach, with vital signs monitoring only. Subsequently, 31 infants will be resuscitation with the addition of Respiratory Function Monitor (RFM) to measure VT. Finally, 31 infants will be resuscitated using vital signs monitor, RFM, and cerebral near-infrared spectroscopy (NIRS). Study participants will be health care providers, and the primary endpoint is based on the recruitment of 93 team leaders (31 in each group). Other team members will also be recruited, to an estimate of 3-5 team members per resuscitation in total (N=279 to 465). Throughout the study, HCPs will be trained to incorporate the use of RFM and NIRS in their resuscitation decision-making, using a combination of weekly in-situ simulations and incorporation of NIRS and RFM teaching into ongoing resuscitation team educational sessions and practice updates. Suggested tidal volume and NIRS goals will be posted as cognitive aids in the resuscitation rooms throughout the study. This sequential approach will allow for resuscitation teams to become acclimatized to the use of RFM and NIRS as routine practice. The sequential approach will also allow the investigators to study time-based changes in perceived mental workload as teams acclimatize to the use of additional monitoring.
After each resuscitation, all team members involved will be asked to complete a brief workload questionnaire (NASA-Task Load Index), which will be linked to the resuscitation. Resuscitations will be video-recorded for analysis of i) resuscitation steps required (e.g. basic steps, bag-mask ventilation, endotracheal intubation, chest compressions, medications), and ii) frequency of use of additional monitoring data (RFM, NIRS) for decision-making. In a subset of resuscitations, the team leader will also be equipped with eye-tracking glasses to record visual attention and pupillary dilatation, and Empatica wristband to record the team leader's heart rate and EDA. Parents of the infants will then be approached for permission to collect more detailed information for the infant's resuscitation and subsequent hospitalization.
Data will be analyzed to compare i) team leader subjective mental workload, ii) composite team mental workload, iii) other workload measures (physical demand, temporal demand, performance, effort, frustration), iii) percentage of visual attention focused on infant, monitoring devices, and other HCPs, iv) frequency of visual access to each monitor display type (vital signs, RFM, NIRS), iv) respiratory function (VT, PIP), v) cerebral NIRS, vi) time to placement of monitoring probes (ECG leads, pulse oximetry, cerebral NIRS), vii) time to first reading for each monitoring device, and viii) time to target HR and SpO2. The primary outcome will be the perceived mental workload of the team leader. Data will be compared between the three groups. In addition, time-dependent changes in team leader and composite mental workload will also be analyzed using a run chart approach. Deferred consent will be obtained from each infant's parents / guardians for collection of hospital course data including: i) incidence of intraventricular hemorrhage, ii) respiratory supports needed, iii) bronchopulmonary dysplasia at 36 weeks, iv) death / survival to discharge.
- Conditions
- Prematurity
- Being tested
- Respiratory Function Monitor (RFM), Cerebral Near-Infrared Spectroscopy (NIRS)
- Keywords
- Neonatal resuscitation, Human Factors, Workload, Respiratory Function Monitoring, cerebral near infrared spectroscopy
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory Function Monitor (RFM)Device
Use of respiratory function monitor to detect tidal volume and expired CO2 to guide mask ventilation during neonatal resuscitation.
Cerebral Near-Infrared Spectroscopy (NIRS)Device
Use of cerebral NIRS to determine cerebral oxygenation to guide oxygen titration during neonatal resuscitation.
| Study group | Role | What they receive |
|---|---|---|
| Group1: ECG+SpO2 only | No intervention | Traditional ECG (heart rate) and SpO2 (pulse oximetry) monitoring for resuscitation only. |
| Group 2: ECG+SpO2+RFM | Active comparator | Addition of Respiratory Function Monitor to ECG and SpO2 during resuscitation. Receives: Device: Respiratory Function Monitor (RFM) |
| Group 3: ECG+SpO2+RFM+NIRS | Active comparator | Addition of cerebral NIRS and Respiratory Function Monitor to ECG and SpO2 during resuscitation. Receives: Device: Respiratory Function Monitor (RFM); Device: Cerebral Near-Infrared Spectroscopy (NIRS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Team Leader's NASA Task Load Index (NASA-TLX) Mental Demand
Team leader's subjective mental demand as reported by the NASA Task Load Index
Measured: Immediately post resuscitation
Secondary outcomes (10)
Composite team mental workload
Team members combined mental workload as measured by NASA Task Load Index
Measured: Immediately post resuscitation
Team Leader Visual Attention Distribution
Percentage of visual attention focused on infant, monitoring devices, and other health care provider as measured by mobile eye-tracking
Measured: During resuscitation
Frequency of visual fixation to monitoring equipment Visual Access to each monitor display type (vital signs, RFM, NIRS)
Frequency of visual fixation to vital signs monitor, Respiratory function monitoring (RFM) screen, and Near Infrared Spectroscopy (NIRS) screen as measured by eye-tracking
Measured: During resuscitation
Time to achieving target heart rate (HR) and oxygen saturation (SpO2)
Time to achieving target HR and SpO2 for age during resuscitation
Measured: During resuscitation
Survival to 36 weeks
Survival to 36 weeks
Measured: 36 weeks
Severe Intraventricular hemorrhage
Grade III or Grade IV Intraventricular hemorrhage
Measured: 36 weeks
Severe Bronchopulmonary Dysplasia
Need for ≥30% oxygen and/or positive pressure, (PPV or NCPAP) at 36 weeks PMA or discharge, whichever comes first.
Measured: 36 weeks
Team Leader's heart rate during resuscitation
Team Leader's median heart rate during resuscitation as an indicator of stress
Measured: During resuscitation
Team Leader's electrodermal activity
Team Leader's electrodermal activity as an indicator of stress
Measured: During resuscitation
Time to apply all probes
Time to apply the probes as needed by the group (SpO2, ECG, NIRS)
Measured: During resuscitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start5 Oct 2020
- Primary completion18 Nov 2021
- Study completion18 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematurityStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04521725
- Sponsor's protocol ID
- Pro00097797
- Status last verified
- Jan 2023
- First submitted
- 18 Aug 2020
- Last updated
- 13 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Additional Monitoring Devices on Healthcare Provider Mental Workload, Visual Attention, and Performance During Neonatal Resuscitation
- ClinicalTrials.gov ID
- NCT04521725
- Acronym / sponsor ID
- Pro00097797
- Conditions
- Prematurity
- Keywords
- Neonatal resuscitation, Human Factors, Workload, Respiratory Function Monitoring, cerebral near infrared spectroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 18 Nov 2021 (actual)
- Study completion
- 18 Nov 2021 (actual)
- First posted
- 20 Aug 2020 (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.
Babies born very early (at less than 32 weeks) usually need help to breath right at birth, also called neonatal resuscitation. Healthcare providers (HCPs) are specially trained to provide this help. HCPs uses information about the baby's condition, such heart rate and oxygen levels, to decide whether they giving the baby effective help, or whether other actions are needed. It can be very stressful for even experienced HCPs to interpret all this data, coordinate a team, make decisions, and perform specialized skills all at the same time.
More recently, new ways of monitoring how a baby is doing neonatal resuscitation has been studied. Respiratory function monitoring (RFM) is a machine that can measure how much air is going into the lungs. This is important as too much air can lead to lung damage, while too little air means that the baby isn't breathing effectively. Another measure is called cerebral near-infrared spectroscopy (cNIRS), which measures oxygen levels in the brain using a probe placed on the forehead. Providing the right amount of oxygen to the most vulnerable organ - the brain - can be important in lowering the risk for injuries to the brain such as brain bleeding. While these machines give us more information, it can also make it even harder for HCPs to focus on the task, adding more complexity to making decisions, adding to their workload, and causing more stress.
To study the effect RFM and cNIRS may have on how affects HCPs workload and stress, the investigators will study HCPs self-reported workload during three time periods - first, doing resuscitations only using basic information (Group 1: heart rate, oxygen levels, direct observations of the baby), second, adding RFM (Group 2), finally adding both RFM and cNIRS (Group 3). A survey called NASA Task Load Index will be used to study HCPs workload. On a small number of teams, the investigators will also track where the leader of the team is looking using eye-tracking glasses, how stressed the leader is by measuring their heart rate, skin sweat, and pupil dilation. Finally, the investigators will collect some information about the baby's resuscitation and hospital stay.
Detailed description
The investigators aim to study 93 resuscitations of very preterm infants (23+0-31+6 weeks), in consecutive groups of 31. First, as a baseline, 31 infants will be resuscitated using the standard approach, with vital signs monitoring only. Subsequently, 31 infants will be resuscitation with the addition of Respiratory Function Monitor (RFM) to measure VT. Finally, 31 infants will be resuscitated using vital signs monitor, RFM, and cerebral near-infrared spectroscopy (NIRS). Study participants will be health care providers, and the primary endpoint is based on the recruitment of 93 team leaders (31 in each group). Other team members will also be recruited, to an estimate of 3-5 team members per resuscitation in total (N=279 to 465). Throughout the study, HCPs will be trained to incorporate the use of RFM and NIRS in their resuscitation decision-making, using a combination of weekly in-situ simulations and incorporation of NIRS and RFM teaching into ongoing resuscitation team educational sessions and practice updates. Suggested tidal volume and NIRS goals will be posted as cognitive aids in the resuscitation rooms throughout the study. This sequential approach will allow for resuscitation teams to become acclimatized to the use of RFM and NIRS as routine practice. The sequential approach will also allow the investigators to study time-based changes in perceived mental workload as teams acclimatize to the use of additional monitoring.
After each resuscitation, all team members involved will be asked to complete a brief workload questionnaire (NASA-Task Load Index), which will be linked to the resuscitation. Resuscitations will be video-recorded for analysis of i) resuscitation steps required (e.g. basic steps, bag-mask ventilation, endotracheal intubation, chest compressions, medications), and ii) frequency of use of additional monitoring data (RFM, NIRS) for decision-making. In a subset of resuscitations, the team leader will also be equipped with eye-tracking glasses to record visual attention and pupillary dilatation, and Empatica wristband to record the team leader's heart rate and EDA. Parents of the infants will then be approached for permission to collect more detailed information for the infant's resuscitation and subsequent hospitalization.
Data will be analyzed to compare i) team leader subjective mental workload, ii) composite team mental workload, iii) other workload measures (physical demand, temporal demand, performance, effort, frustration), iii) percentage of visual attention focused on infant, monitoring devices, and other HCPs, iv) frequency of visual access to each monitor display type (vital signs, RFM, NIRS), iv) respiratory function (VT, PIP), v) cerebral NIRS, vi) time to placement of monitoring probes (ECG leads, pulse oximetry, cerebral NIRS), vii) time to first reading for each monitoring device, and viii) time to target HR and SpO2. The primary outcome will be the perceived mental workload of the team leader. Data will be compared between the three groups. In addition, time-dependent changes in team leader and composite mental workload will also be analyzed using a run chart approach. Deferred consent will be obtained from each infant's parents / guardians for collection of hospital course data including: i) incidence of intraventricular hemorrhage, ii) respiratory supports needed, iii) bronchopulmonary dysplasia at 36 weeks, iv) death / survival to discharge.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group1: ECG+SpO2 only | No intervention | –Traditional ECG (heart rate) and SpO2 (pulse oximetry) monitoring for resuscitation only. |
| Group 2: ECG+SpO2+RFM | Active comparator | Device: Respiratory Function Monitor (RFM)Addition of Respiratory Function Monitor to ECG and SpO2 during resuscitation. |
| Group 3: ECG+SpO2+RFM+NIRS | Active comparator | Device: Respiratory Function Monitor (RFM), Device: Cerebral Near-Infrared Spectroscopy (NIRS)Addition of cerebral NIRS and Respiratory Function Monitor to ECG and SpO2 during resuscitation. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- HCPs participating in resuscitations of very preterm infants (23+0-31+6 weeks) at the Royal Alexandra Hospital Neonatal Intensive Care Unit (NICU), a Level III NICU will be included.
- Multiple gestations will be analyzed individually as separate resuscitations. HCPs will include different levels of experience and different disciplines (registered nurses, advance practice nurses, respiratory therapists, neonatal nurse practitioners, pediatric residents, neonatal fellows, clinical associates, and neonatal consultants).
- All HCPs who participate in the resuscitation, regardless of role, will be eligible for completion of NASA-TLX surveys.
- Participants who act as team leader will be eligible to be fitted with eye-tracking glasses to record their visual attention and Empatica E4 wristbands to measure physiological stress measurements.
- For resuscitated infants, hospital outcomes will be included with parental consent.
Key exclusion criteria (2 listed)
- Teams involved in the resuscitation of infants born with congenital malformations, or involved in the care of infants for whom active resuscitation is not planned (i.e., comfort care only for periviable gestations) will be excluded.
- Teams who do not consent to participate will also be excluded.
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 |
|---|---|---|
| Respiratory Function Monitor (RFM)Use of respiratory function monitor to detect tidal volume and expired CO2 to guide mask ventilation during neonatal resuscitation. | Device | Group 2: ECG+SpO2+RFM, Group 3: ECG+SpO2+RFM+NIRS |
| Cerebral Near-Infrared Spectroscopy (NIRS)Use of cerebral NIRS to determine cerebral oxygenation to guide oxygen titration during neonatal resuscitation. | Device | Group 3: ECG+SpO2+RFM+NIRS |
Primary outcome
Team Leader's NASA Task Load Index (NASA-TLX) Mental Demand
Time frame: Immediately post resuscitation
Team leader's subjective mental demand as reported by the NASA Task Load Index
10 secondary outcomes
Composite team mental workload
Time frame: Immediately post resuscitation
Team Leader Visual Attention Distribution
Time frame: During resuscitation
Frequency of visual fixation to monitoring equipment Visual Access to each monitor display type (vital signs, RFM, NIRS)
Time frame: During resuscitation
Time to achieving target heart rate (HR) and oxygen saturation (SpO2)
Time frame: During resuscitation
Survival to 36 weeks
Time frame: 36 weeks
Severe Intraventricular hemorrhage
Time frame: 36 weeks
Severe Bronchopulmonary Dysplasia
Time frame: 36 weeks
Team Leader's heart rate during resuscitation
Time frame: During resuscitation
Team Leader's electrodermal activity
Time frame: During resuscitation
Time to apply all probes
Time frame: During resuscitation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Prematurity
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
RecruitingObservational study
Multidimensional Dynamic Early Warning System for Neonatal Necrotizing Enterocolitis: A Multicenter Clinical Study
NEC - Necrotizing Enterocolitis
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory Function Monitor (RFM) and Cerebral Near-Infrared Spectroscopy (NIRS) in people with Prematurity, run by University of Alberta at 1 site in Canada.
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 13 Jan 2023. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Team Leader's NASA Task Load Index (NASA-TLX) Mental Demand (time frame: Immediately post resuscitation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jan 2023.