Coronary Artery Bypass Graft Triple VesselNCT01559610
Preoperatively Orientation in Cardiac Surgery: Nurses Intervention on Patients Recovery
A study testing Intervention Group in people with Coronary Artery Bypass Graft Triple Vessel and Heart Valve Diseases, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
Trial summary
The purpose of this study is to determine whether the guidelines preoperative performed by a nurse contribute to the recovery of the patient submitted to cardiac surgery compared with the guidelines for routine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Bypass Graft Triple Vessel, Heart Valve Diseases
- What is being tested?
- Intervention Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2008to Mar 2009
- 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
- Primary Elective Cardiac Surgical Procedures
- Age above 18 years old
- At least 24 hours of hospitalization before the procedure
Who cannot join
- Patients who do not accept and do not signed a consenting term
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether the guidelines preoperative performed by a nurse contribute to the recovery of the patient submitted to cardiac surgery compared with the guidelines for routine.
Read the detailed description
This is a randomized clinical trial, which included patients submitted to cardiac surgery on both sexes. They are divided in two groups: control group and intervention group.
- Being tested
- Intervention Group
- Keywords
- cardiac surgery, orientation, nursing
- Medical subject headings
- Heart Valve Diseases, Orientation, Spatial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention GroupOther
Also called No applicable
The patients were instructed by a nurse
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Received preoperative guidance by a member of healthcare team with the aid of checklist Receives: Other: Intervention Group |
| Group intervention | Other | preoperative guideline by a nurse Receives: Other: Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
knowledge
three questions applied on the second day of recovery at the nursery room, after the intensive care unit discharge,about type of anesthesia,endotracheal tube function and time of healing of the sternum bone.The questions had only one correct alternative.Since the randomization until the questionnaire,the study follow up took seven days.For the analysis,answers of the questionnaire were separated and the number of answers for each,and divided into the two groups.The results were presented in graphic and tables.
Measured: seven days
Secondary outcomes (1)
satisfaction
five questions applied on the second day of recovery at the nursery room.The patients had to graduate their level of satisfaction from unsatisfied to very satisfied according to orientation received about the prior,intraoperative and recovering period of surgery as well as the nursery and medical orientation provided.Since the randomization until the questionnaire,the study follow up took seven days.For the analysis answers of the questionnaire were separated and the number of answers for each,and divided into the two groups.The results were presented in graphic and tables.
Measured: seven days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2012 (estimated)
- Study startAug 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Bypass Graft Triple VesselStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juliane A Rodrigues, nursing, Principal investigator, Brasil:Instituto de Cardiologia do Rio Grande do Sul/Fundacao Universitaria de Cardiologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01559610
- Sponsor's protocol ID
- UP 4150/08
- Status last verified
- Mar 2012
- First submitted
- 23 Feb 2012
- Last updated
- 21 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperatively Orientation in Cardiac Surgery: Nurses Intervention on Patients Recovery
- ClinicalTrials.gov ID
- NCT01559610
- Acronym / sponsor ID
- UP 4150/08
- Keywords
- cardiac surgery, orientation, nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do SulUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 21 Mar 2012 (estimated)
- 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 purpose of this study is to determine whether the guidelines preoperative performed by a nurse contribute to the recovery of the patient submitted to cardiac surgery compared with the guidelines for routine.
Detailed description
This is a randomized clinical trial, which included patients submitted to cardiac surgery on both sexes. They are divided in two groups: control group and intervention group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | Other: Intervention GroupReceived preoperative guidance by a member of healthcare team with the aid of checklist |
| Group intervention | Other | Other: Intervention Grouppreoperative guideline by a nurse |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary Elective Cardiac Surgical Procedures
- Age above 18 years old
- At least 24 hours of hospitalization before the procedure
Key exclusion criteria (1 listed)
- Patients who do not accept and do not signed a consenting term
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 |
|---|---|---|
| Intervention GroupAlso: No applicableThe patients were instructed by a nurse | Other | Control Group, Group intervention |
Primary outcome
knowledge
Time frame: seven days
three questions applied on the second day of recovery at the nursery room, after the intensive care unit discharge,about type of anesthesia,endotracheal tube function and time of healing of the sternum bone.The questions had only one correct alternative.Since the randomization until the questionnaire,the study follow up took seven days.For the analysis,answers of the questionnaire were separated and the number of answers for each,and divided into the two groups.The results were presented in graphic and tables.
1 secondary outcome
satisfaction
Time frame: seven days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2012.
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.
Juliane A Rodrigues, nursing principal investigator
Brasil:Instituto de Cardiologia do Rio Grande do Sul/Fundacao Universitaria de Cardiologia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group in people with Coronary Artery Bypass Graft Triple Vessel and Heart Valve Diseases, run by Instituto de Cardiologia do Rio Grande do Sul at 1 site in Brazil.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 21 Mar 2012. 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
knowledge (time frame: seven days). 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 21 Mar 2012.