The Rescuer Fatigue During Cardiopulmonary Resuscitation in Manikin by Using Personal Protective Equipment.
Primary Purpose
Cardiac Arrest
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
wearing level D personal protective equipment
wearing Level C personal protective equipment with N-95
wearing Level C personal protective equipment with Powered Air-Purifying Respiratory
Sponsored by
About this trial
This is an interventional other trial for Cardiac Arrest focused on measuring personal protective equipment, rescuer fatigue, N-95, Powered Air-Purifying Respiratory
Eligibility Criteria
Inclusion Criteria:
- Physicians and nurses at An Nan Hospital, with more than one year of work experience, with Advanced cardiac life support or basic life support certificate
Exclusion Criteria:
- back pain in the past, spine surgery, sciatica, coronary heart disease, and lung diseases such as asthma or chronic obstructive pulmonary disease. Pregnant women are also excluded.
Sites / Locations
- An Nan Hospital, China Medical University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
CPR with level D PPE
CPR with level C PPE
CPR with Level C PPE + PAPR
Arm Description
The participant doing CPR for 5 minutes with wearing level D personal protective equipment with surgical face mask
The participant doing CPR for 5 minutes with Level C personal protective equipment with N-95 face mask
The participant doing CPR for 5 minutes with Level C personal protective equipment with Powered Air-Purifying Respiratory.
Outcomes
Primary Outcome Measures
effective chest compression ratio
each chest compression that deep greater than 5 cm, around 100~120 times per minutes and recoil during each chest compression
Secondary Outcome Measures
quantitative fitness factor of face mask
using porta count to detect the quantitative fitness factor of face mask. data from 0~200, if >=100 remain qualified outcome
Full Information
NCT ID
NCT04802109
First Posted
March 14, 2021
Last Updated
March 13, 2022
Sponsor
An-Nan Hospital, China Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04802109
Brief Title
The Rescuer Fatigue During Cardiopulmonary Resuscitation in Manikin by Using Personal Protective Equipment.
Official Title
The Impact of Rescuer Fatigue and Quality During Cardiopulmonary Resuscitation by Using Personal Protective Equipment. A Randomized Controlled Crossover Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
An-Nan Hospital, China Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Background:
High-quality cardiopulmonary resuscitation is the key to recovering patients with sudden cardiac death. However, when the environment is exposure to biologic hazard, the medical personnel need to use different personal protective equipment while doing CPR, and this difficulty is greatly increased. The research on this part is quite limited, and the results need to be further analyzed.
Purpose:
Compare the effects of CPR wearing different levels of personal protective equipment on CPR quality and rescue fatigue.
Material & Methods:
This study is designed as a prospective randomized crossover trial with an expected total of 40 volunteer participants, performed during 2021 April 1 to 2021 June 30. Each participant is required to perform a five-minute CPR in kneeling position using three different types of personal protective equipment. These three modes are Level D protective equipment with surgical mask, Level C protective equipment with N-95 mask, and Level-C protective equipment with Powered Air Purifying Respirator. Participants are physicians or nurses at the hospital. The participation are randomly assigned to the order of the three modes, and each mode can be rested for 120 minutes. Laerdal Skillreporter is used for CPR and quality measurement. The main results were effective chest compression ratio, correct chest depth ratio, correct chest recoil ratio and chest compression number per minute. The secondary results were personal blood pressure before and after the CPR, heartbeat, pulse oximeter, number of breaths, and subjective fatigue index (VAS 1 ~ 100 points), Questionnaire for the opinion of wearing personal protective equipment and using the porta count test to test the N-95 face mask for its quantitative fitness factor before and during CPR, and infrared detector for qualitative fitness test.
Detailed Description
Background:
High-quality cardiopulmonary resuscitation is the key to recovering patients with sudden cardiac death. However, when the environment is exposure to biologic hazard, the medical personnel need to use different personal protective equipment while doing CPR, and this difficulty is greatly increased. The research on this part is quite limited, and the results need to be further analyzed.
Purpose:
Compare the effects of CPR wearing different levels of personal protective equipment on CPR quality and rescue fatigue.
Material & Methods:
This study is designed as a prospective randomized crossover trial with an expected total of 40 volunteer participants, performed during 2021 April 1 to 2021 June 30. Each participant is required to perform a five-minute CPR in kneeling position using three different types of personal protective equipment. These three modes are Level D protective equipment with surgical mask, Level C protective equipment with N-95 mask, and Level-C protective equipment with Powered Air Purifying Respirator. Participants are physicians or nurses at the hospital. The participation are randomly assigned to the order of the three modes, and each mode can be rested for 120 minutes. Laerdal Skillreporter is used for CPR and quality measurement. The main results were effective chest compression ratio, correct chest depth ratio, correct chest recoil ratio and chest compression number per minute. The secondary results were personal blood pressure before and after the CPR, heartbeat, pulse oximeter, number of breaths, and subjective fatigue index (VAS 1 ~ 100 points), Questionnaire for the opinion of wearing personal protective equipment and using the porta count test to test the N-95 face mask for its quantitative fitness factor before and during CPR, and infrared detector for qualitative fitness test.
Inclusion criteria:
physicians and nurses from An Nan Hospital, with more than one year of work experience, possessing ACLS or BLS certificate, regardless of gender, height and weight.
Exclusion criteria:
back pain in the past, spine surgery, sciatica, coronary heart disease, and lung diseases such as asthma or chronic obstructive pulmonary disease. Pregnant women need to be excluded.
Statistic Method On the basis of our previous study (Foo NP,et al.Rescuer fatigue and cardiopulmonary resuscitation positions: A randomized controlled crossover trial. Resuscitation. 2010;81(5):579-584). we estimated that with a level of 0.05, a power of 80%, and an effect size of 0.6, a sample size of 18 participants would be sufficient for evaluating the primary outcome. We applied the Shapiro-Wilk test to evaluate the normality of the distribution of data. Then, we applied ANOVA for repeat measures and the Bonferroni procedure to evaluate the differences among and between different positions if the data fit the Gaussian distribution, and the Friedman test and Wilcoxon signed rank test if the data did not fit the Gaussian distribution. All the statistical tests were performed at the two-tailed level of significance at 0.05, and all statistical analyses were performed using SPSS for Windows, Version 17.0 (SPSS Inc., Chicago, U.S.A.).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest
Keywords
personal protective equipment, rescuer fatigue, N-95, Powered Air-Purifying Respiratory
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
This study is designed as a prospective randomized crossover trial . Each participant is required to perform a five-minute CPR in kneeling position using three different types of personal protective equipment. After each round of CPR for 5 minutes, the participants can rest for two hours before the next round of CPR with different type of personal protective equipment
Masking
Outcomes Assessor
Masking Description
It is impossible to masking the participant, care provider during the CPR study.
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CPR with level D PPE
Arm Type
Placebo Comparator
Arm Description
The participant doing CPR for 5 minutes with wearing level D personal protective equipment with surgical face mask
Arm Title
CPR with level C PPE
Arm Type
Experimental
Arm Description
The participant doing CPR for 5 minutes with Level C personal protective equipment with N-95 face mask
Arm Title
CPR with Level C PPE + PAPR
Arm Type
Experimental
Arm Description
The participant doing CPR for 5 minutes with Level C personal protective equipment with Powered Air-Purifying Respiratory.
Intervention Type
Device
Intervention Name(s)
wearing level D personal protective equipment
Intervention Description
rubber gloves + surgical face mask + general isolation clothing
Intervention Type
Device
Intervention Name(s)
wearing Level C personal protective equipment with N-95
Intervention Description
C-level protective clothing+ N95 mask + disposable protective clothing ("Ten Quin" Medial Apparel) + foot cover + rubber gloves + mask + general isolation clothing
Intervention Type
Device
Intervention Name(s)
wearing Level C personal protective equipment with Powered Air-Purifying Respiratory
Intervention Description
C-level protective clothing+ N95 mask + disposable protective clothing ("Ten Quin" Medial Apparel) + foot cover + rubber gloves + mask + general isolation clothing+Powered Air-Purifying Respiratory
Primary Outcome Measure Information:
Title
effective chest compression ratio
Description
each chest compression that deep greater than 5 cm, around 100~120 times per minutes and recoil during each chest compression
Time Frame
5 minutes
Secondary Outcome Measure Information:
Title
quantitative fitness factor of face mask
Description
using porta count to detect the quantitative fitness factor of face mask. data from 0~200, if >=100 remain qualified outcome
Time Frame
5 minutes
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Physicians and nurses at An Nan Hospital, with more than one year of work experience, with Advanced cardiac life support or basic life support certificate
Exclusion Criteria:
back pain in the past, spine surgery, sciatica, coronary heart disease, and lung diseases such as asthma or chronic obstructive pulmonary disease. Pregnant women are also excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ning-Ping Foo, PhD
Organizational Affiliation
Director of Department of Emergency Medicine
Official's Role
Study Director
Facility Information:
Facility Name
An Nan Hospital, China Medical University
City
Tainan
ZIP/Postal Code
709204
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
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The Rescuer Fatigue During Cardiopulmonary Resuscitation in Manikin by Using Personal Protective Equipment.
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