MRSOPA-Drills to Improve Mask Ventilation in the Delivery Room

NCT02375230 | Completed

• 1 other identifier: Pro00054147
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

Establishing breathing after birth is vital for survival and long-term health of premature babies. 10% of all preterm babies fail to breathe after birth and require help with breathing. When infants need help with breathing the clinical team will place a small mask on the babies face to give some breaths to help the baby breath (what the investigators call mask ventilation). This procedure is done million times a day around the world and several times a day here at the Royal Alexandra Hospital. Providing these breaths via mask ventilation is the most difficult step in helping a baby breath at birth. If this is provided wrongly then baby does not receive enough oxygen, which could damage the brain and even cause death. To keep the skill level of every staff member up-to-date every staff member is required to re-train this rescue breaths via mask ventilation once every two years. The investigators believe this is not enough and that daily trainings are necessary to keep your skills up-to-date. The investigators aim to compare to different teaching techniques using daily trainings to see if either improves the skills of the resuscitator providing mask ventilation The study will last 7 month (baseline observations (2 months), intervention period (3 months), After trial period (2 months) The investigators will use our routinely used equipment to record neonatal resuscitation and the investigators also routinely make video recordings to evaluate performance during resuscitation.

Conditions

Apnea; Bradycardia

Keywords

Neonatal Resuscitation; Respiratory Function Tests; Neonatal Simulation; Resuscitation Teaching

Outcome Measures

Primary Outcomes (1)

• Mask leak

  within 10min after birth

Secondary Outcomes (4)

• Rate of Intubation

  within 60min after birth

• Apgar score at 1min

  1min after birth

• Apgar score at 5min

  5min after birth

• Rate of Chest compression

  within 10min after birth

Study Arms (2)

Control

PLACEBO COMPARATOR

"Control group" Health care provider randomized to the control group will receive a copy of the NRP text pages discussing MR SOPA at every shift for self-study. They will be encouraged by the educator to study these pages for five minutes at every shift. The educator will be there to answer questions if they arise.

Procedure: Control group

MR SOPA

ACTIVE COMPARATOR

Health care provider randomized to the "MR SOPA" group will receive MR SOPA training provided by a qualified educator on every shift. This training will be five minutes long and will consist of each MR SOPA step. These corrective steps will be demonstrated and practiced on a low-fidelity neonatal mannequin. Each participant will receive five minutes of training at the start of each shift. The educator will teach mask adjustment, and airway reposition. If either of these first steps is unsuccessful the participant will learn about mouth and nose suction, open mouth and increase of airway pressure. All participants will also learn and practice alternative airways placement including intubation and laryngeal mask airway placement.

Procedure: MR SOPA

Interventions

Control group PROCEDURE

Health care provider randomized to the control group will receive a copy of the NRP text pages discussing MR SOPA at every shift for self-study. They will be encouraged by the educator to study these pages for five minutes at every shift. The educator will be there to answer questions if they arise.

Control

MR SOPA PROCEDURE

Health care provider randomized to the "MR SOPA" group will receive MR SOPA training provided by a qualified educator on every shift. This training will be five minutes long and will consist of each MR SOPA step. These corrective steps will be demonstrated and practiced on a low-fidelity neonatal mannequin. The alternative airway practice will be performed on an intubation mannequin in the DR also placed on the DR resuscitation unit. Each participant will receive five minutes of training at the start of each shift.

MR SOPA

Eligibility Criteria

• Age: Up to 10 Minutes
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants \<33 weeks gestation requiring respiratory support at birth will be included if member of the Resuscitation-Stabilization-Triage team (RST-team) enrolled in study attend deliveries.

You may not qualify if:

• Infants of parents who decline consent

Sponsors & Collaborators

• University of Alberta: lead
• American Academy of Pediatrics: collaborator

Study Sites (1)

Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

Location

MeSH Terms

Conditions

Apnea; Bradycardia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Georg Schmolzer, MD,PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2015
• First Posted: March 2, 2015
• Study Start: May 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 15, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)