Cardiac ArrestNCT04802109
The Rescuer Fatigue During Cardiopulmonary Resuscitation in Manikin by Using Personal Protective Equipment.
A study testing wearing level D personal protective equipment, wearing Level C personal protective equipment with N-95 and wearing Level C personal protective equipment with Powered Air-Purifying Respiratory in people with Cardiac Arrest, run by An-Nan Hospital, China Medical University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- wearing level D personal protective equipment, wearing Level C personal protective equipment with N-95 and wearing Level C personal protective equipment with Powered Air-Purifying Respiratory
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Apr 2021to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Rescuer Fatigue and Quality During Cardiopulmonary Resuscitation by Using Personal Protective Equipment. A Randomized Controlled Crossover Trial.
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.
Read more
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.
Read the 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.).
- Conditions
- Cardiac Arrest
- Being tested
- 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
- Keywords
- personal protective equipment, rescuer fatigue, N-95, Powered Air-Purifying Respiratory
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wearing level D personal protective equipmentDevice
rubber gloves + surgical face mask + general isolation clothing
wearing Level C personal protective equipment with N-95Device
C-level protective clothing+ N95 mask + disposable protective clothing ("Ten Quin" Medial Apparel) + foot cover + rubber gloves + mask + general isolation clothing
wearing Level C personal protective equipment with Powered Air-Purifying RespiratoryDevice
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
| Study group | Role | What they receive |
|---|---|---|
| CPR with level D PPE | Placebo comparator | The participant doing CPR for 5 minutes with wearing level D personal protective equipment with surgical face mask Receives: Device: wearing level D personal protective equipment; Device: wearing Level C personal protective equipment with N-95; Device: wearing Level C personal protective equipment with Powered Air-Purifying Respiratory |
| CPR with level C PPE | Experimental | The participant doing CPR for 5 minutes with Level C personal protective equipment with N-95 face mask Receives: Device: wearing level D personal protective equipment; Device: wearing Level C personal protective equipment with N-95; Device: wearing Level C personal protective equipment with Powered Air-Purifying Respiratory |
| CPR with Level C PPE + PAPR | Experimental | The participant doing CPR for 5 minutes with Level C personal protective equipment with Powered Air-Purifying Respiratory. Receives: Device: wearing level D personal protective equipment; Device: wearing Level C personal protective equipment with N-95; Device: wearing Level C personal protective equipment with Powered Air-Purifying Respiratory |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 minutes
Secondary outcomes (1)
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
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start1 Apr 2021
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- An-Nan Hospital, China Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ning-Ping Foo, PhD, Study director, Director of Department of Emergency Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04802109
- Sponsor's protocol ID
- TMANH109-REC017
- Status last verified
- Mar 2022
- First submitted
- 14 Mar 2021
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cheng CH, Cheng YY, Yuan MK, Juang YJ, Zeng XY, Chen CY, Foo NP. Impact of Personal Protective Equipment on Cardiopulmonary Resuscitation and Rescuer Safety. Emerg Med Int. 2023 Nov 30;2023:9697442. doi: 10.1155/2023/9697442. eCollection 2023.
PubMed 38077106
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Rescuer Fatigue and Quality During Cardiopulmonary Resuscitation by Using Personal Protective Equipment. A Randomized Controlled Crossover Trial.
- ClinicalTrials.gov ID
- NCT04802109
- Acronym / sponsor ID
- TMANH109-REC017
- Conditions
- Cardiac Arrest
- Keywords
- personal protective equipment, rescuer fatigue, N-95, Powered Air-Purifying Respiratory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- An-Nan Hospital, China Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 17 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| CPR with level D PPE | Placebo comparator | Device: wearing level D personal protective equipment, Device: wearing Level C personal protective equipment with N-95, Device: wearing Level C personal protective equipment with Powered Air-Purifying RespiratoryThe participant doing CPR for 5 minutes with wearing level D personal protective equipment with surgical face mask |
| CPR with level C PPE | Experimental | Device: wearing level D personal protective equipment, Device: wearing Level C personal protective equipment with N-95, Device: wearing Level C personal protective equipment with Powered Air-Purifying RespiratoryThe participant doing CPR for 5 minutes with Level C personal protective equipment with N-95 face mask |
| CPR with Level C PPE + PAPR | Experimental | Device: wearing level D personal protective equipment, Device: wearing Level C personal protective equipment with N-95, Device: wearing Level C personal protective equipment with Powered Air-Purifying RespiratoryThe participant doing CPR for 5 minutes with Level C personal protective equipment with Powered Air-Purifying Respiratory. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| wearing level D personal protective equipmentrubber gloves + surgical face mask + general isolation clothing | Device | CPR with Level C PPE + PAPR, CPR with level C PPE, CPR with level D PPE |
| wearing Level C personal protective equipment with N-95C-level protective clothing+ N95 mask + disposable protective clothing ("Ten Quin" Medial Apparel) + foot cover + rubber gloves + mask + general isolation clothing | Device | CPR with Level C PPE + PAPR, CPR with level C PPE, CPR with level D PPE |
| wearing Level C personal protective equipment with Powered Air-Purifying RespiratoryC-level protective clothing+ N95 mask + disposable protective clothing ("Ten Quin" Medial Apparel) + foot cover + rubber gloves + mask + general isolation clothing+Powered Air-Purifying Respiratory | Device | CPR with Level C PPE + PAPR, CPR with level C PPE, CPR with level D PPE |
Primary outcome
effective chest compression ratio
Time frame: 5 minutes
each chest compression that deep greater than 5 cm, around 100~120 times per minutes and recoil during each chest compression
1 secondary outcome
quantitative fitness factor of face mask
Time frame: 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2022.
- Derived from this study: PubMed 38077106Cheng CH, Cheng YY, Yuan MK, Juang YJ, Zeng XY, Chen CY, Foo NP. Impact of Personal Protective Equipment on Cardiopulmonary Resuscitation and Rescuer Safety. Emerg Med Int. 2023 Nov 30;2023:9697442. doi: 10.1155/2023/9697442. eCollection 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ning-Ping Foo, PhD study director
Director of Department of Emergency Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wearing level D personal protective equipment, wearing Level C personal protective equipment with N-95 and wearing Level C personal protective equipment with Powered Air-Purifying Respiratory in people with Cardiac Arrest, run by An-Nan Hospital, China Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effective chest compression ratio (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04802109, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2022.