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Completed

NCT Number: NCT04802109

The Rescuer Fatigue During Cardiopulmonary Resuscitation in Manikin by Using Personal Protective Equipment.

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

An Nan Hospital, China Medical University

Tainan, 709204, Taiwan

About this study

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.).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

wearing level D personal protective equipment

Device

rubber gloves + surgical face mask + general isolation clothing

wearing Level C personal protective equipment with N-95

Device

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 Respiratory

Device

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 outcomes

  1. 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

Secondary outcomes

  1. quantitative fitness factor of face mask

    Time frame: 5 minutes

    using porta count to detect the quantitative fitness factor of face mask. data from 0~200, if >=100 remain qualified outcome

Sponsors and collaborators

Lead sponsor

An-Nan Hospital, China Medical University

Other

Registry information

Official study title

The Impact of Rescuer Fatigue and Quality During Cardiopulmonary Resuscitation by Using Personal Protective Equipment. A Randomized Controlled Crossover Trial.

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 17, 2021
Registry last updated
Mar 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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