NCT04802109

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 17, 2021

Completed
15 days until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

March 15, 2022

Status Verified

March 1, 2022

Enrollment Period

3 months

First QC Date

March 14, 2021

Last Update Submit

March 13, 2022

Conditions

Keywords

personal protective equipmentrescuer fatigueN-95Powered Air-Purifying Respiratory

Outcome Measures

Primary Outcomes (1)

  • 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

    5 minutes

Secondary Outcomes (1)

  • quantitative fitness factor of face mask

    5 minutes

Study Arms (3)

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

Device: wearing level D personal protective equipmentDevice: wearing Level C personal protective equipment with N-95Device: 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

Device: wearing level D personal protective equipmentDevice: wearing Level C personal protective equipment with N-95Device: 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.

Device: wearing level D personal protective equipmentDevice: wearing Level C personal protective equipment with N-95Device: wearing Level C personal protective equipment with Powered Air-Purifying Respiratory

Interventions

rubber gloves + surgical face mask + general isolation clothing

CPR with Level C PPE + PAPRCPR with level C PPECPR with level D PPE

C-level protective clothing+ N95 mask + disposable protective clothing ("Ten Quin" Medial Apparel) + foot cover + rubber gloves + mask + general isolation clothing

CPR with Level C PPE + PAPRCPR with level C PPECPR with level D PPE

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

CPR with Level C PPE + PAPRCPR with level C PPECPR with level D PPE

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

An Nan Hospital, China Medical University

Tainan, 709204, Taiwan

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Ning-Ping Foo, PhD

    Director of Department of Emergency Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
It is impossible to masking the participant, care provider during the CPR study.
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2021

First Posted

March 17, 2021

Study Start

April 1, 2021

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

March 15, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations