Ignite Creation Date:
2024-05-06 @ 3:44 AM
Last Modification Date:
2024-10-26 @ 11:38 AM
Study NCT ID:
NCT02368392
Status:
COMPLETED
Last Update Posted:
2016-02-17
First Post:
2015-02-14
Brief Title:
National Cardiac Arrest Survey
Sponsor:
Ministry of Health Sri Lanka
Organization:
Ministry of Health Sri Lanka
Study Overview
Official Title:
National Cardiac Arrest Survey of Sri Lanka
Status:
COMPLETED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NCAS
Brief Summary:
The aim of this study is to describe incidence of in-hospital deaths and outcomes after attempted cardiac arrest resuscitation availability of resuscitation equipment and medical staff training in state Hospitals of Sri Lanka
Detailed Description:
4 General objective To describe incidence of in-hospital deaths outcomes after attempted cardiac arrest resuscitation and availability of resuscitation equipment in Sri Lankan state Hospitals
41 Specific objectives
To describe the incidence of in-hospital deaths in state sector Hospitals in Sri Lanka
To describe the availability of resources for cardiac arrest management in these settings
To describe the incidence of attempted resuscitation after cardiac arrests
To describe the immediate outcomes after attempted resuscitation for cardiac arrests
To describe the ICU Hospital and 30 day post discharge outcomes of these patients
To describe the health related quality of patients who survived to 1 year
5 Methodology 51 Study one 511 Study design One week cross-sectional study
512 Study setting In all state sector Hospitals with Base Hospitals and above
513 Administrative process Once ethical review process has been completed The Hospital DirectorsMedical Superintendent and through them the Hospital Consultants will be officially informed of the study by the office of the Deputy Director General Education Training and Research DDG ETR at the Ministry of Health
Medical Officers will be nominated for the study through the same office A small financial incentive will be provided for these Doctors during this study period as below The investigators will also seek permission from the Steering committee of National Intensive Care Surveillance to obtain ICU admission outcome and follow-up data for IHCA patients from the NICS database
514 Study population All patients who died in-hospital or those on whom CPR was attempted within the time period of the study
5141 Exclusions criteria
Dead on arrival at Hospital
Neonate less than 28 days
515 Study sample Entire population
516 Study period One week period in JulyAugust 2014
517 Sample size One week period will be studied
518 Sampling method Not applicable
519 Data collection tools During the study period nominated and pre-trained medical officers from each Hospital will complete a questionnaire using an online form on a daily basis The data collector will interview each Ward Sister House Officer or senior nurse twice around 7 am and 7 pm daily Non- ward areas such as operating theatres emergency rooms will also be covered This process will be piloted in five hospitals prior to the study to fine tune the process
5191 Data validation Death register in the wardmortuary or in the Matrons office will be used to validate the data collected on Hospital deaths and any discrepancies resolved Random validation of the data collected at Hospital level will be done centrally on a daily basis during the one-week period
ICU admission reasons will also be collected from all ICUs during this period to detect ICU admissions due to in-hospital cardiac arrests which can also be used as a method of validation
5110 Study variables The following will be collected daily during the one week period
Number of in-ward deaths
Number of attempted resuscitations
Number of successful resuscitations and their subsequent locations
Number admitted to ICU name and BHT number following resuscitation and location of the ICUs
Total number of in-ward patients at midnight daily during the study period
In addition at the beginning of the study period the facilities available for resuscitation will be collected at wardtheatre against a standard resuscitation council equipment checklist The staff participation in previous resuscitation training will be gathered anonymously at the same time This information will only be collected once
52 Study two 521 Study design Longitudinal study
522 Study setting All Intensive Care Units to which the patients successfully resuscitated have been admitted
523 Study period From the beginning of the study period of study 1 above and until 30 days after ICU discharge for the last patient admitted to an ICU after successful resuscitation up to a maximum of 90 days from the start of the study period
524 Sample size All patients admitted to an ICU after successful resuscitation from study 1 above will be included We are unable to estimate a sample size for this study as the number of patients admitted after cardiac arrests over this period is not known The purpose of this part of the study is to actually know what number of patients are admitted to ICU after resuscitation and what their outcomes are No causative association is proposed as an product of this part of the studyWe have selected a one-week recruitment period as this is a national study and we feel this is a feasible duration for us
525 Sampling method All patients who had successful resuscitation and were admitted to ICU in study 1 will be included
526 Data collection tools The data will be gathered after appropriate permission has been sought as above from the National Intensive Care Surveillance NICS database No new data will need to be gathered from these ICUs If the ICU is not part of the NICS network we will follow up these resuscitated patients in these non-NICS ICUs Health related Quality of Lifeneurological and disability status of these patients will be reviewed using SF-12 EQ-5Dand MRS from those who survived to 1 year
527 Study variables The following data will be collected for each eligible patient using the National Intensive Care Surveillance database where the ICU is part of the network
Outcomes at ICU discharge
Outcomes at Hospital discharge
Outcomes at 30 day post discharge In the non-NICS ICUs we will determine ICU outcomes by contacting the ICUs at least once a week We will also determine hospital and 30 days outcome by obtaining a contact telephone number of the patient or the next of kin This is similar to the methodology we currently employ for patients admitted to NICS ICUs
Health related Quality of Life neurological and disability status of patients who survived at 6 months and up to 1 year
6 Statistical analysis Data will be analyzed using Statistical Package for Social Sciences 18 and Stata 13
Discrete variables are expressed as counts percentage and continuous variables as means standard deviations SD and median inter quartile range IQR For description of variables standard descriptive statistics will be used For comparison of continuous variables t test will be used while chi square will be used to compare discrete variables
Multivariate logistic regression analysis will be used to describe the prevalence of selected factors as antecedents or contributory features of cardiac arrests
7 Ethics 71 Consent Permission will be taken from the relevant Authorities of the Ministry of Health and Hospitals as described in detail above Personal identifier data of patients will not be collected except for Name BHT number address and telephone number of those successfully resuscitated The investigators and data collectors will not come in direct contact with the patients except when determining 30 day outcome
72 Risks to the patient There are no obvious risks to patient
73 Benefits Potential benefits are many at individual patient level Hospital level and national level The study will enable quantification of the burden of recognized cardiac arrests their outcomes and possible antecedentcontributory factors to enable the formulation of concrete strategies to improve care
74 Confidentiality Data extraction sheet will be completed only by the nominated medical officers or by the proposed expert committee Data will be stored in a computer and only the authorized personal will have access to this information and the information will be password protected and backed up
75 Dissemination of information The findings will be disseminated in the form of abstracts submitted for scientific session journal articles and presentations They may be used for local or national guideline preparation
76 Beneficiaries There are three main categories of beneficiaries The Ministry of Health benefits from information by knowing the ground situation and being able to plan and direct the donors where improvement are needed both in resources as well as capacity building The staff benefits by being able to identify areas of improvement in the services given for IHCA and resuscitation and thus has the opportunity to improve the skills on resuscitation Thus data can be used to develop services and the human resources in improving IHCA management and patient out come
41 Specific objectives
To describe the incidence of in-hospital deaths in state sector Hospitals in Sri Lanka
To describe the availability of resources for cardiac arrest management in these settings
To describe the incidence of attempted resuscitation after cardiac arrests
To describe the immediate outcomes after attempted resuscitation for cardiac arrests
To describe the ICU Hospital and 30 day post discharge outcomes of these patients
To describe the health related quality of patients who survived to 1 year
5 Methodology 51 Study one 511 Study design One week cross-sectional study
512 Study setting In all state sector Hospitals with Base Hospitals and above
513 Administrative process Once ethical review process has been completed The Hospital DirectorsMedical Superintendent and through them the Hospital Consultants will be officially informed of the study by the office of the Deputy Director General Education Training and Research DDG ETR at the Ministry of Health
Medical Officers will be nominated for the study through the same office A small financial incentive will be provided for these Doctors during this study period as below The investigators will also seek permission from the Steering committee of National Intensive Care Surveillance to obtain ICU admission outcome and follow-up data for IHCA patients from the NICS database
514 Study population All patients who died in-hospital or those on whom CPR was attempted within the time period of the study
5141 Exclusions criteria
Dead on arrival at Hospital
Neonate less than 28 days
515 Study sample Entire population
516 Study period One week period in JulyAugust 2014
517 Sample size One week period will be studied
518 Sampling method Not applicable
519 Data collection tools During the study period nominated and pre-trained medical officers from each Hospital will complete a questionnaire using an online form on a daily basis The data collector will interview each Ward Sister House Officer or senior nurse twice around 7 am and 7 pm daily Non- ward areas such as operating theatres emergency rooms will also be covered This process will be piloted in five hospitals prior to the study to fine tune the process
5191 Data validation Death register in the wardmortuary or in the Matrons office will be used to validate the data collected on Hospital deaths and any discrepancies resolved Random validation of the data collected at Hospital level will be done centrally on a daily basis during the one-week period
ICU admission reasons will also be collected from all ICUs during this period to detect ICU admissions due to in-hospital cardiac arrests which can also be used as a method of validation
5110 Study variables The following will be collected daily during the one week period
Number of in-ward deaths
Number of attempted resuscitations
Number of successful resuscitations and their subsequent locations
Number admitted to ICU name and BHT number following resuscitation and location of the ICUs
Total number of in-ward patients at midnight daily during the study period
In addition at the beginning of the study period the facilities available for resuscitation will be collected at wardtheatre against a standard resuscitation council equipment checklist The staff participation in previous resuscitation training will be gathered anonymously at the same time This information will only be collected once
52 Study two 521 Study design Longitudinal study
522 Study setting All Intensive Care Units to which the patients successfully resuscitated have been admitted
523 Study period From the beginning of the study period of study 1 above and until 30 days after ICU discharge for the last patient admitted to an ICU after successful resuscitation up to a maximum of 90 days from the start of the study period
524 Sample size All patients admitted to an ICU after successful resuscitation from study 1 above will be included We are unable to estimate a sample size for this study as the number of patients admitted after cardiac arrests over this period is not known The purpose of this part of the study is to actually know what number of patients are admitted to ICU after resuscitation and what their outcomes are No causative association is proposed as an product of this part of the studyWe have selected a one-week recruitment period as this is a national study and we feel this is a feasible duration for us
525 Sampling method All patients who had successful resuscitation and were admitted to ICU in study 1 will be included
526 Data collection tools The data will be gathered after appropriate permission has been sought as above from the National Intensive Care Surveillance NICS database No new data will need to be gathered from these ICUs If the ICU is not part of the NICS network we will follow up these resuscitated patients in these non-NICS ICUs Health related Quality of Lifeneurological and disability status of these patients will be reviewed using SF-12 EQ-5Dand MRS from those who survived to 1 year
527 Study variables The following data will be collected for each eligible patient using the National Intensive Care Surveillance database where the ICU is part of the network
Outcomes at ICU discharge
Outcomes at Hospital discharge
Outcomes at 30 day post discharge In the non-NICS ICUs we will determine ICU outcomes by contacting the ICUs at least once a week We will also determine hospital and 30 days outcome by obtaining a contact telephone number of the patient or the next of kin This is similar to the methodology we currently employ for patients admitted to NICS ICUs
Health related Quality of Life neurological and disability status of patients who survived at 6 months and up to 1 year
6 Statistical analysis Data will be analyzed using Statistical Package for Social Sciences 18 and Stata 13
Discrete variables are expressed as counts percentage and continuous variables as means standard deviations SD and median inter quartile range IQR For description of variables standard descriptive statistics will be used For comparison of continuous variables t test will be used while chi square will be used to compare discrete variables
Multivariate logistic regression analysis will be used to describe the prevalence of selected factors as antecedents or contributory features of cardiac arrests
7 Ethics 71 Consent Permission will be taken from the relevant Authorities of the Ministry of Health and Hospitals as described in detail above Personal identifier data of patients will not be collected except for Name BHT number address and telephone number of those successfully resuscitated The investigators and data collectors will not come in direct contact with the patients except when determining 30 day outcome
72 Risks to the patient There are no obvious risks to patient
73 Benefits Potential benefits are many at individual patient level Hospital level and national level The study will enable quantification of the burden of recognized cardiac arrests their outcomes and possible antecedentcontributory factors to enable the formulation of concrete strategies to improve care
74 Confidentiality Data extraction sheet will be completed only by the nominated medical officers or by the proposed expert committee Data will be stored in a computer and only the authorized personal will have access to this information and the information will be password protected and backed up
75 Dissemination of information The findings will be disseminated in the form of abstracts submitted for scientific session journal articles and presentations They may be used for local or national guideline preparation
76 Beneficiaries There are three main categories of beneficiaries The Ministry of Health benefits from information by knowing the ground situation and being able to plan and direct the donors where improvement are needed both in resources as well as capacity building The staff benefits by being able to identify areas of improvement in the services given for IHCA and resuscitation and thus has the opportunity to improve the skills on resuscitation Thus data can be used to develop services and the human resources in improving IHCA management and patient out come
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None