Effect of Monitoring Devices on Healthcare Provider Performance During Neonatal Resuscitation

NCT04521725 | Completed

• 1 other identifier: Pro00097797
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Prematurity

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

  Immediately post resuscitation

Secondary Outcomes (10)

• Composite team mental workload

  Immediately post resuscitation

• Team Leader Visual Attention Distribution

  During resuscitation

• Frequency of visual fixation to monitoring equipment Visual Access to each monitor display type (vital signs, RFM, NIRS)

  During resuscitation

• Time to achieving target heart rate (HR) and oxygen saturation (SpO2)

  During resuscitation

• Survival to 36 weeks

  36 weeks

Study Arms (3)

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.

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.

Device: Respiratory Function Monitor (RFM); Device: Cerebral Near-Infrared Spectroscopy (NIRS)

Interventions

Respiratory Function Monitor (RFM) DEVICE

Use of respiratory function monitor to detect tidal volume and expired CO2 to guide mask ventilation during neonatal resuscitation.

Group 2: ECG+SpO2+RFM; Group 3: ECG+SpO2+RFM+NIRS

Cerebral Near-Infrared Spectroscopy (NIRS) DEVICE

Use of cerebral NIRS to determine cerebral oxygenation to guide oxygen titration during neonatal resuscitation.

Group 3: ECG+SpO2+RFM+NIRS

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Royal Alexandra Hospital

Edmonton, Alberta, Canada

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 20, 2020
• Study Start: October 5, 2020
• Primary Completion: November 18, 2021
• Study Completion: November 18, 2021
• Last Updated: January 13, 2023

Record last verified: 2023-01

Locations

CA (1)