Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04802109 |
| Other study ID # |
TMANH109-REC017 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2021 |
| Est. completion date |
June 30, 2021 |
Study information
| Verified date |
March 2022 |
| Source |
An-Nan Hospital, China Medical University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.).
