Complication of Surgical ProcedureNCT04205825
Development and Evaluation of the Impact of a Safety Checklist Adapted to Interventional Cardiology
A study testing The New Safety Checklist in people with Complication of Surgical Procedure, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
The hypothesis is that patients undergoing cardiac catheterization, in which the New Safety Checklist has been used, have fewer perioperative complications compared to patients in which the habitual practice has been used. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complication of Surgical Procedure
- What is being tested?
- The New Safety Checklist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6,000 participants
- Where
- 1 siteSpain
- Study dates
- 2 Dec 2019to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (>18 years) undergoing cardiological intervention in hemodynamic units and interventionist cardiology.
- Patients who accept to participate in the study.
Who cannot join
- Patients undergoing urgent procedure.
- Patients requiring ventilatory support or in a situation of hemodynamic instability.
- Patients with cognitive impairment, mental disability or other serious difficulty in communication.
- Patients with insufficient fluidity of the main languages.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
FGS Hospital de la Santa Creu i Sant Pau
Barcelona, 08041
Adrian Marquez Lopez, RN. MsC. PhD student., +349329100 ext. 7926, amarquez@santpau.cat
About this study
The hypothesis is that patients undergoing cardiac catheterization, in which the New Safety Checklist has been used, have fewer perioperative complications compared to patients in which the habitual practice has been used.
Read the detailed description
The aim of this study is to develop a New Safety Checklist in perioperative patients undergoing cardiac catheterization in interventional cardiology units and assess it impact on the incidence of perioperative complications compared to habitual practice.
The study will consist in two phases; the first phase: development of the New Safety Checklist, and the second phase will be a multicenter randomized clinical trial, a parallel two-arm corresponding to the use of the New Safety Checklist compared to the habitual practice in all patients undergoing cardiac catheterization in interventional cardiology units, according to the inclusion criteria..
The expected number of patients in this trial will be 6000. The principal outcome of this study will be: the incidence of perioperative complications. The secondary outcomes will be: socio-demographic data, clinical patient data and procedure type data. Data collection will be done through reviewing clinical history.
- Conditions
- Complication of Surgical Procedure
- Being tested
- The New Safety Checklist
- Keywords
- Nursing, Patient Safety, Checklist, Cardiology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The New Safety ChecklistOther
Patients randomized in the New Safety Checklist intervention, nurses will use the New Safety Checklist, which we have named: INCARDIO-PASS (Interventional CARDIOlogy-Patient Safety System) checklist.
| Study group | Role | What they receive |
|---|---|---|
| New Safety Checklist | Experimental | Patients randomized in the New Safety Checklist intervention, nurses will use the New Safety Checklist, which we have named: INCARDIO-PASS (Interventional CARDIOlogy-Patient Safety System) checklist. Receives: Other: The New Safety Checklist |
| Habitual Practice | No intervention | Patients randomized in this arm they will receive the habitual practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
INCIDENCE of PERIOPERATIVE COMPLICATIONS
The perioperative complications will be collected after randomization, from discharge or up to24 hours post-procedure.
The clinical history will be reviewed to evaluate the incidence of complications. Expected complications will be: severe systemic complications (major cardiovascular events [MACE], coronary artery complications, and structural complications), peripheral vascular complications, and reactions to contrast media.
Measured: from the discharge or up to 24 hours post-procedure
Secondary outcomes (3)
Socio-demographic data
Socio-demographic data will be collected after randomization, from the discharge or up to 24 hours post-procedure.
The clinical history will be reviewed to collect socio-demographic data: gender (male/female), age (absolute value), weight (kilograms) and height (centimeters).
Measured: from the discharge or up to 24 hours post-procedure
Clinical data
Clinical data will be collected after randomization, from the discharge or up to 24 hours post-procedure.
The clinical history will be reviewed to collect cardiovascular risk factors (dyslipemia, smoking), clinical record (medical allergies, ischemic, valvular heart disease, cardiomyopathy, arrhythmias, disease pulmonary, platelet antiaggregant treatment).
Measured: from the discharge or up to 24 hours post-procedure
Procedure data
Procedure data will be collected after randomization, from the discharge or up to 24 hours post-procedure.
The clinical history will be reviewed to collect procedure data, tipe of procedure done (coronary, structural, diagnostic procedure, right catheterization).
Measured: from the discharge or up to 24 hours post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start2 Dec 2019
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complication of Surgical ProcedureStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04205825
- Sponsor's protocol ID
- IIBSP-LVS-2017-49
- Status last verified
- Dec 2019
- First submitted
- 12 Dec 2019
- Last updated
- 20 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of the Impact of a Safety Checklist Adapted to Interventional Cardiology
- ClinicalTrials.gov ID
- NCT04205825
- Acronym / sponsor ID
- IIBSP-LVS-2017-49
- Conditions
- Complication of Surgical Procedure
- Keywords
- Nursing, Patient Safety, Checklist, Cardiology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- 2 Dec 2019 (actual)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 20 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hypothesis is that patients undergoing cardiac catheterization, in which the New Safety Checklist has been used, have fewer perioperative complications compared to patients in which the habitual practice has been used.
Detailed description
The aim of this study is to develop a New Safety Checklist in perioperative patients undergoing cardiac catheterization in interventional cardiology units and assess it impact on the incidence of perioperative complications compared to habitual practice.
The study will consist in two phases; the first phase: development of the New Safety Checklist, and the second phase will be a multicenter randomized clinical trial, a parallel two-arm corresponding to the use of the New Safety Checklist compared to the habitual practice in all patients undergoing cardiac catheterization in interventional cardiology units, according to the inclusion criteria..
The expected number of patients in this trial will be 6000. The principal outcome of this study will be: the incidence of perioperative complications. The secondary outcomes will be: socio-demographic data, clinical patient data and procedure type data. Data collection will be done through reviewing clinical history.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New Safety Checklist | Experimental | Other: The New Safety ChecklistPatients randomized in the New Safety Checklist intervention, nurses will use the New Safety Checklist, which we have named: INCARDIO-PASS (Interventional CARDIOlogy-Patient Safety System) checklist. |
| Habitual Practice | No intervention | –Patients randomized in this arm they will receive the habitual practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients (>18 years) undergoing cardiological intervention in hemodynamic units and interventionist cardiology.
- Patients who accept to participate in the study.
Key exclusion criteria (4 listed)
- Patients undergoing urgent procedure.
- Patients requiring ventilatory support or in a situation of hemodynamic instability.
- Patients with cognitive impairment, mental disability or other serious difficulty in communication.
- Patients with insufficient fluidity of the main languages.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The New Safety ChecklistPatients randomized in the New Safety Checklist intervention, nurses will use the New Safety Checklist, which we have named: INCARDIO-PASS (Interventional CARDIOlogy-Patient Safety System) checklist. | Other | New Safety Checklist |
Primary outcome
INCIDENCE of PERIOPERATIVE COMPLICATIONS
Time frame: from the discharge or up to 24 hours post-procedure
The perioperative complications will be collected after randomization, from discharge or up to24 hours post-procedure. The clinical history will be reviewed to evaluate the incidence of complications. Expected complications will be: severe systemic complications (major cardiovascular events [MACE], coronary artery complications, and structural complications), peripheral vascular complications, and reactions to contrast media.
3 secondary outcomes
Socio-demographic data
Time frame: from the discharge or up to 24 hours post-procedure
Clinical data
Time frame: from the discharge or up to 24 hours post-procedure
Procedure data
Time frame: from the discharge or up to 24 hours post-procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The New Safety Checklist in people with Complication of Surgical Procedure, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Adrian Marquez Lopez, RN. MsC. PhD student. (+342919000 ext. 7926, amarquez@santpau.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
INCIDENCE of PERIOPERATIVE COMPLICATIONS (time frame: from the discharge or up to 24 hours post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2019.