Effect of Monitoring Devices on Healthcare Provider Performance During Neonatal Resuscitation

• ClinicalTrials.gov Identifier: NCT04521725
• Recruitment Status: Recruiting
• First Posted: August 20, 2020
• Last Update Posted: November 4, 2020
• Sponsor: University of Alberta
• Information provided by (Responsible Party): University of Alberta

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Prematurity	Device: Respiratory Function Monitor (RFM); Device: Cerebral Near-Infrared Spectroscopy (NIRS)	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 93 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Effect of Additional Monitoring Devices on Healthcare Provider Mental Workload, Visual Attention, and Performance During Neonatal Resuscitation
• Actual Study Start Date: October 5, 2020
• Estimated Primary Completion Date: September 2021
• Estimated Study Completion Date: June 2022

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Group1: ECG+SpO2 only; Traditional ECG (heart rate) and SpO2 (pulse oximetry) monitoring for resuscitation only.
Active Comparator: Group 2: ECG+SpO2+RFM; Addition of Respiratory Function Monitor to ECG and SpO2 during resuscitation.	Device: Respiratory Function Monitor (RFM); Use of respiratory function monitor to detect tidal volume and expired CO2 to guide mask ventilation during neonatal resuscitation.
Active Comparator: Group 3: ECG+SpO2+RFM+NIRS; Addition of cerebral NIRS and Respiratory Function Monitor to ECG and SpO2 during resuscitation.	Device: Respiratory Function Monitor (RFM); Use of respiratory function monitor to detect tidal volume and expired CO2 to guide mask ventilation during neonatal resuscitation.; Device: Cerebral Near-Infrared Spectroscopy (NIRS); Use of cerebral NIRS to determine cerebral oxygenation to guide oxygen titration during neonatal resuscitation.

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. Composite team mental workload [ Time Frame: Immediately post resuscitation ]
   Team members combined mental workload as measured by NASA Task Load Index
2. Team Leader Visual Attention Distribution [ Time Frame: During resuscitation ]
   Percentage of visual attention focused on infant, monitoring devices, and other health care provider as measured by mobile eye-tracking
3. Frequency of visual fixation to monitoring equipment Visual Access to each monitor display type (vital signs, RFM, NIRS) [ Time Frame: During resuscitation ]
   Frequency of visual fixation to vital signs monitor, Respiratory function monitoring (RFM) screen, and Near Infrared Spectroscopy (NIRS) screen as measured by eye-tracking
4. Time to achieving target heart rate (HR) and oxygen saturation (SpO2) [ Time Frame: During resuscitation ]
   Time to achieving target HR and SpO2 for age during resuscitation
5. Survival to 36 weeks [ Time Frame: 36 weeks ]
   Survival to 36 weeks
6. Severe Intraventricular hemorrhage [ Time Frame: 36 weeks ]
   Grade III or Grade IV Intraventricular hemorrhage
7. Severe Bronchopulmonary Dysplasia [ Time Frame: 36 weeks ]
   Need for ≥30% oxygen and/or positive pressure, (PPV or NCPAP) at 36 weeks PMA or discharge, whichever comes first.
8. Team Leader's heart rate during resuscitation [ Time Frame: During resuscitation ]
   Team Leader's median heart rate during resuscitation as an indicator of stress
9. Team Leader's electrodermal activity [ Time Frame: During resuscitation ]
   Team Leader's electrodermal activity as an indicator of stress
10. Time to apply all probes [ Time Frame: During resuscitation ]
    Time to apply the probes as needed by the group (SpO2, ECG, NIRS)

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Contacts and Locations

Contacts

Contact: Brenda H Law, MD; 780-745-4647; blaw2@ualberta.ca

Locations

Canada, Alberta

Royal Alexandra Hospital; Recruiting

Edmonton, Alberta, Canada

Contact: Brenda Law, MD 780-735-4647

Sponsors and Collaborators

University of Alberta

More Information

• Responsible Party: University of Alberta
• ClinicalTrials.gov Identifier: NCT04521725
• Other Study ID Numbers: Pro00097797
• First Posted: August 20, 2020
• Last Update Posted: November 4, 2020
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Alberta:

Neonatal resuscitation; Human Factors; Workload; Respiratory Function Monitoring; cerebral near infrared spectroscopy

Additional relevant MeSH terms:

Premature Birth; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications