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

Sponsor
An-Nan Hospital, China Medical University (Other)
Overall Status
Completed
CT.gov ID
NCT04802109
Collaborator
(none)
40
1
3
3
13.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • 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
N/A

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

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention 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 equipmentThis 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 (Outcomes Assessor)
Masking Description:
It is impossible to masking the participant, care provider during the CPR study.
Primary Purpose:
Other
Official Title:
The Impact of Rescuer Fatigue and Quality During Cardiopulmonary Resuscitation by Using Personal Protective Equipment. A Randomized Controlled Crossover Trial.
Actual Study Start Date :
Apr 1, 2021
Actual Primary Completion Date :
Jun 30, 2021
Actual Study Completion Date :
Jun 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: CPR with level D PPE

The participant doing CPR for 5 minutes with wearing level D personal protective equipment with surgical face mask

Device: wearing level D personal protective equipment
rubber gloves + surgical face mask + general isolation clothing

Device: wearing Level C personal protective equipment with N-95
C-level protective clothing+ N95 mask + disposable protective clothing ("Ten Quin" Medial Apparel) + foot cover + rubber gloves + mask + general isolation clothing

Device: wearing Level C personal protective equipment with Powered Air-Purifying Respiratory
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

Experimental: CPR with level C PPE

The participant doing CPR for 5 minutes with Level C personal protective equipment with N-95 face mask

Device: wearing level D personal protective equipment
rubber gloves + surgical face mask + general isolation clothing

Device: wearing Level C personal protective equipment with N-95
C-level protective clothing+ N95 mask + disposable protective clothing ("Ten Quin" Medial Apparel) + foot cover + rubber gloves + mask + general isolation clothing

Device: wearing Level C personal protective equipment with Powered Air-Purifying Respiratory
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

Experimental: CPR with Level C PPE + PAPR

The participant doing CPR for 5 minutes with Level C personal protective equipment with Powered Air-Purifying Respiratory.

Device: wearing level D personal protective equipment
rubber gloves + surgical face mask + general isolation clothing

Device: wearing Level C personal protective equipment with N-95
C-level protective clothing+ N95 mask + disposable protective clothing ("Ten Quin" Medial Apparel) + foot cover + rubber gloves + mask + general isolation clothing

Device: wearing Level C personal protective equipment with Powered Air-Purifying Respiratory
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

Outcome Measures

Primary Outcome Measures

  1. effective chest compression ratio [5 minutes]

    each chest compression that deep greater than 5 cm, around 100~120 times per minutes and recoil during each chest compression

Secondary Outcome Measures

  1. quantitative fitness factor of face mask [5 minutes]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 An Nan Hospital, China Medical University Tainan Taiwan 709204

Sponsors and Collaborators

  • An-Nan Hospital, China Medical University

Investigators

  • Study Director: Ning-Ping Foo, PhD, Director of Department of Emergency Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
An-Nan Hospital, China Medical University
ClinicalTrials.gov Identifier:
NCT04802109
Other Study ID Numbers:
  • TMANH109-REC017
First Posted:
Mar 17, 2021
Last Update Posted:
Mar 15, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by An-Nan Hospital, China Medical University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 15, 2022