Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02998749 |
| Other study ID # |
Gasping1 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
December 16, 2016 |
| Last updated |
December 19, 2016 |
| Start date |
July 2013 |
| Est. completion date |
November 2016 |
Study information
| Verified date |
December 2016 |
| Source |
Charles University, Czech Republic |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
Czech Republic: Ethics Committee |
| Study type |
Observational
|
Clinical Trial Summary
The aim of our retrospective clinical study was to examine the association between agonal
breathing, return of spontaneous circulation (ROSC), and long-term survival. A secondary aim
was to examine role of basic life support (BLS) and response time. Our hypothesis is that
agonal breathing has positive effects on both primary and secondary endpoints.
Description:
Aims Agonal breathing ("gasping for air") has previously been found to be associated with
the outcomes of out-of-hospital cardiac arrest (OHCA) patients on which resuscitation was
attempted. On the other hand, little is known, about agonal breathing with regard to whether
it is a positive factor for survival after hospital admission and how it relates to the
patient's future quality of life. For this reason we have undertaken a retrospective study
using a comprehensive emergency medical service (EMS) database from the Central Bohemian
region of the Czech Republic. The primary endpoint of the study was to assess if agonal
breathing present when EMS arrives has a positive impact on the six-month survival of OHCA
patients, which was independent of other factors like EMS response time and BLS provision.
The secondary endpoints sought to determine if agonal breathing positively impacts ROSC and
an evaluation of various factors that can influence agonal breathing, specifically response
time and provision of BLS.
Method The data were recorded using the Utstein protocol. Only anonymized data were used for
analysis. The data were derived from the EMS registry of the Central Bohemian Region, which
is the largest EMS in the Czech Republic. The study sample included all OHCA cases, of
presumed cardiac origin, that where resuscitated by the EMS between 1st July 2013 and 30th
June 2014 (n = 584). Two subsequent patient outcomes: (1) return of spontaneous circulation
(defined as spontaneous circulation at hospital admission) and (2) six-month survival were
assessed in patients with and without agonal breathing. Six-month survival data of OHCA
patients of presumed cardiac origin was derived from administrative insurance registries or
medical records of patients, with only aggregated data being available.
Factors that may influence the presence of agonal breathing, specifically BLS provision
before a professional EMS team reached the patient and second, EMS team response times, were
also examined. BLS provision by lay persons was reported by the first-on-scene EMS team as
(yes/no) and phone assisted CPR was registered by the dispatcher as (yes/no). BLS was
considered to have been provided if any of the following activities (1) resuscitation by a
bystander, (2) phone assisted CPR, or (3) both were recorded as having been performed. The
response time was calculated as the elapsed time between recorded activation of an EMS team
and the on scene arrival time.
Other covariates such as age and sex were also available and analyzed. The initial
difference in response time between the groups was assessed using the T-test. For
categorical variables, the chi-square test was used. Simple and multivariate logistic
regression models were used to assess relationships between factors related to the presence
of agonal breathing and ROSC. A p-value of < 0.05 was considered statistically significant.
