Trial Outcomes & Findings for CPR Quality Between Flexible Stretcher and Standard Stretcher in OHCA (NCT NCT02527694)

Results Overview

Chest compression fraction was calculated as proportion of CPR time spent providing compressions.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

49 participants

Primary outcome timeframe

During the total prehospital resuscitation time

Results posted on

2019-01-15

Participant Flow

Adult OHCAs transported by five ambulances in a metropolitan area with a population of 3.5 million (many of whom lived in high-rise buildings) from September to October (before-phase) and November to December (afterphase) in 2015 were collected.

Participant milestones

Participant milestones
Measure	Flexible Stretcher Cart Group Patients in this group will be transported on the new flexible stretcher cart and receive mechanical CPR during transport to the hospital. The intervention will be given during elevator transport (if applicable) as well as in the moving ambulance. Flexible EMS stretcher cart: The flexible stretcher cart is an innovative EMS stretcher cart built to be flexible to fit in smaller spaces such as elevators. The flexible stretcher bends at the hip joint as well as at the knee joint, so that the patient can be put in head-up position at 30 degrees elevation with elevated legs. mechanical CPR	Standard Stretcher Cart Group Patients in this group will be transported on the standard stretcher cart and receive manual CPR during transport to the hospital. The resuscitation protocol will follow the current standard protocol used by the EMS providers.
Overall Study STARTED	20	29
Overall Study COMPLETED	10	21
Overall Study NOT COMPLETED	10	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

CPR Quality Between Flexible Stretcher and Standard Stretcher in OHCA

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Stretcher Cart Group n=21 Participants Standard strecher for manual compression on supine position	Flexible Stretcher Cart Group n=10 Participants We manufactured a stretcher that hinged at multiple points to be reduced to fit into small elevators with a patient on board. The stretcher can be used to transport patients without cardiac arrest in the same manner as a standard stretcher. In cases of cardiac arrest, the upper mattress of the stretcher could be removed to install the mechanical compression device. The stretcher has additional sidebars that can be used to attach and lock mechanical CPR devices that are commercially available in Korea. The patient' legs were elevated with V shape body position through knee flection and hip flection on accessory steel bar when the patients are being transporting to avoid decrease of venous return by leg-down. A l0ad-distributing band-type mechanical compression device, the AutoPulse® (ZOLL Medical, Chelmsford, MA, USA), was used for this study.	Total n=31 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	4 Participants n=7 Participants	14 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants	6 Participants n=7 Participants	17 Participants n=5 Participants
Age, Continuous	66 years n=5 Participants	66 years n=7 Participants	66 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	2 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	8 Participants n=7 Participants	21 Participants n=5 Participants
Region of Enrollment South Korea	21 Participants n=5 Participants	10 Participants n=7 Participants	31 Participants n=5 Participants

PRIMARY outcome

Timeframe: During the total prehospital resuscitation time

Chest compression fraction was calculated as proportion of CPR time spent providing compressions.

Outcome measures

Outcome measures
Measure	Reducible Stretcher Group n=10 Participants We manufactured a stretcher that hinged at multiple points to be reduced to fit into small elevators with a patient on board. The stretcher can be used to transport patients without cardiac arrest in the same manner as a standard stretcher. In cases of cardiac arrest, the upper mattress of the stretcher could be removed to install the mechanical compression device. The stretcher has additional sidebars that can be used to attach and lock mechanical CPR devices that are commercially available in Korea. The patient' legs were elevated with V shape body position through knee flection and hip flection on accessory steel bar when the patients are being transporting to avoid decrease of venous return by leg-down. A l0ad-distributing band-type mechanical compression device, the AutoPulse® (ZOLL Medical, Chelmsford, MA, USA), was used for this study.	Standard Stretcher Cart Group n=21 Participants Standard strecher for manual compression on supine position
Comparison of Percentage of Chest Compression Fraction Between Before- and After-phase Groups	85.2 Percentage of chest compression fraction Interval 83.4 to 86.3	80.1 Percentage of chest compression fraction Interval 68.0 to 85.2

SECONDARY outcome

Timeframe: During total prehospital resuscitation

Outcome measures

Outcome measures
Measure	Reducible Stretcher Group n=10 Participants We manufactured a stretcher that hinged at multiple points to be reduced to fit into small elevators with a patient on board. The stretcher can be used to transport patients without cardiac arrest in the same manner as a standard stretcher. In cases of cardiac arrest, the upper mattress of the stretcher could be removed to install the mechanical compression device. The stretcher has additional sidebars that can be used to attach and lock mechanical CPR devices that are commercially available in Korea. The patient' legs were elevated with V shape body position through knee flection and hip flection on accessory steel bar when the patients are being transporting to avoid decrease of venous return by leg-down. A l0ad-distributing band-type mechanical compression device, the AutoPulse® (ZOLL Medical, Chelmsford, MA, USA), was used for this study.	Standard Stretcher Cart Group n=21 Participants Standard strecher for manual compression on supine position
CPR Duration	1131 seconds Interval 974.0 to 1262.0	909 seconds Interval 594.0 to 1013.0

Adverse Events

Standard Stretcher Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Reducible Stretcher Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

So Yeon Kong

Seoul National University Hospital

Phone: 82220724412

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place