Effectiveness of Video-assisted Cardiopulmonary Resuscitation

• ClinicalTrials.gov Identifier: NCT05639868
• Recruitment Status: Completed
• First Posted: December 6, 2022
• Last Update Posted: January 25, 2023
• Sponsor: University of Pecs
• Information provided by (Responsible Party): Dr. Bálint Bánfai, University of Pecs

Tracking Information

• First Submitted Date: November 14, 2022
• First Posted Date: December 6, 2022
• Last Update Posted Date: January 25, 2023
• Actual Study Start Date: December 1, 2022
• Actual Primary Completion Date: January 20, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 2, 2022)

• Quality of chest compressions (depth of chest compressions). [ Time Frame: During procedure ]
  Chest compression depth will be evaluated by a manikin connected to a CPR software.
• Quality of chest compressions (rate of chest compressions). [ Time Frame: During procedure ]
  Chest compression rate will be evaluated by a manikin connected to a CPR software.
• Quality of chest compressions (hand position of chest compressions). [ Time Frame: During procedure ]
  Hand position during chest compression will be evaluated by observation.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: December 2, 2022)

• Time factors of CPR [ Time Frame: During procedure ]
  Measuring the time of check breathing, time to recognize cardiac arrest, time to first chest compression, and cumulative time of no-flow time by the CPR software and observation.
• Attitude of bystanders. [ Time Frame: Immediately after the CPR procedure (within 15 minutes) ]
  Subjective feelings after performing CPR based on a short survey using Likert-scale based queries (lower numbers indicate worse, higher score indicates better opinion).

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effectiveness of Video-assisted Cardiopulmonary Resuscitation
• Official Title: Is Video-assisted Cardiopulmonary Resuscitation More Effective Than Telephone-assisted or Not-instructed Cardiopulmonary Resuscitation by Laypeople? - a Randomized Controlled Simulation Study

Brief Summary

Sudden cardiac arrest is a major public health problem worldwide and it is one of the leading causes of death in industrialized countries. Emergency Medical Services (EMS) dispatchers play an important role to recognize cardiac arrest and give help to the lay first responder via telephone CPR (T-CPR) which improves survival rates. The current technology allows the live video connection between the scene and the dispatcher which provides the opportunity for video-assisted CPR (V-CPR) via the bystander smartphone.

Effectiveness of V-CPR has only been investigated to a limited extent. Comparing effectiveness of V-CPR (effectiveness of chest compression, time parameters eg. time to first chest compression) to T-CPR and non-instructed CPR can be useful to implement V-CPR technology.

Detailed Description

Sudden cardiac arrest is a major public health problem worldwide and it is one of the leading causes of death in industrialized countries. EMS dispatchers play an important role to recognize cardiac arrest and give help to the lay first responder via telephone CPR (T-CPR) which improves survival rates. The current technology allows the live video connection between the scene and the dispatcher which provides the opportunity for video-assisted CPR (V-CPR) via the bystander smartphone.

Effectiveness of V-CPR has only been investigated to a limited extent. Comparing effectiveness of V-CPR (quality of chest compressions: depth, rate, hand position), time parameters: time to recognize cardiac arrest, time of check breathing, total no-flow time, to first chest compression) to T-CPR and non-instructed CPR can be useful to implement V-CPR technology.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Cardiac Arrest

Intervention

• Other: Video-assisted CPR
  Participants in V-CPR group get video-based (vocal and visual) instructions from the dispatcher.
• Other: Telephone-assisted CPR
  Participants in T-CPR group get voice-based (vocal) instructions from the dispatcher.

Study Arms

• Active Comparator: T-CPR
  Participants perform telephone-assisted CPR based on the European Resuscitation Council (ERC) 2021 guidelines.
  Interventions:

  • Other: Video-assisted CPR
  • Other: Telephone-assisted CPR
• Experimental: V-CPR
  Participants perform video-assisted CPR based on the European Resuscitation Council (ERC) 2021 guidelines.
  Interventions:

  • Other: Video-assisted CPR
  • Other: Telephone-assisted CPR
• No Intervention: Unassisted CPR
  CPR without dispatcher instructions.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: December 2, 2022): 150
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: January 23, 2023
• Actual Primary Completion Date: January 20, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• healthy volunteer

Exclusion Criteria:

• healthcare professionals (paramedics, nurses, etc.)
• pregnant women
• people with cardio-pulmonary and musculoskeletal diseases or any other impairment that would risk harm for the volunteer while performing CPR for 2 minutes
• psychological disabilities

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 30 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Hungary

Administrative Information

• NCT Number: NCT05639868
• Other Study ID Numbers: Upecs_V-CPR
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Dr. Bálint Bánfai, University of Pecs
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Pecs
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Bálint Bánfai, PhD; University of Pecs

• PRS Account: University of Pecs
• Verification Date: January 2023