Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04521725 |
| Other study ID # |
Pro00097797 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 5, 2020 |
| Est. completion date |
November 18, 2021 |
Study information
| Verified date |
January 2023 |
| Source |
University of Alberta |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
