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- Klinische proef NCT04802109
The Rescuer Fatigue During Cardiopulmonary Resuscitation in Manikin by Using Personal Protective Equipment.
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.
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.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.).
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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-
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Tainan, Taiwan, 709204
- An Nan Hospital, China Medical University
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Placebo-vergelijker: CPR with level D PPE
The participant doing CPR for 5 minutes with wearing level D personal protective equipment with surgical face mask
|
rubber gloves + surgical face mask + general isolation clothing
C-level protective clothing+ N95 mask + disposable protective clothing ("Ten Quin" Medial Apparel) + foot cover + rubber gloves + mask + general isolation clothing
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
|
|
Experimenteel: CPR with level C PPE
The participant doing CPR for 5 minutes with Level C personal protective equipment with N-95 face mask
|
rubber gloves + surgical face mask + general isolation clothing
C-level protective clothing+ N95 mask + disposable protective clothing ("Ten Quin" Medial Apparel) + foot cover + rubber gloves + mask + general isolation clothing
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
|
|
Experimenteel: CPR with Level C PPE + PAPR
The participant doing CPR for 5 minutes with Level C personal protective equipment with Powered Air-Purifying Respiratory.
|
rubber gloves + surgical face mask + general isolation clothing
C-level protective clothing+ N95 mask + disposable protective clothing ("Ten Quin" Medial Apparel) + foot cover + rubber gloves + mask + general isolation clothing
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
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
effective chest compression ratio
Tijdsspanne: 5 minutes
|
each chest compression that deep greater than 5 cm, around 100~120 times per minutes and recoil during each chest compression
|
5 minutes
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
quantitative fitness factor of face mask
Tijdsspanne: 5 minutes
|
using porta count to detect the quantitative fitness factor of face mask.
data from 0~200, if >=100 remain qualified outcome
|
5 minutes
|
Medewerkers en onderzoekers
Onderzoekers
- Studie directeur: Ning-Ping Foo, PhD, Director of Department of Emergency Medicine
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- TMANH109-REC017
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
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