Coronary Artery DiseaseCABG PRDNCT02074371
Postoperative Respiratory Depression After Cardiac Surgery
An observational study of Coronary Artery Disease, run by Ovidiu Constantin Baltatu at 1 site in Brazil.
Trial summary
Coronary artery bypass graft surgery (CABG) is associated with postoperative respiratory depression. In this study we aimed at investigating perioperative parameters that could predict the nadir of postoperative respiratory function impairment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 44 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2012to Nov 2012
- Phase
- Observational
- 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
Study population: Patients with coronary artery disease submitted to elective CABG with CPB.
Who may be able to join
- patients of both sexes older than 18 years submitted to CABG with CPB, presence of coronary disease confirmed by coronary angiography, use of the left internal thoracic artery and/or saphena, patients who remained in spontaneous ventilation on the first postoperative day, absence of chronic or acute pulmonary disease, and giving written informed consent to participate in the study.
Who cannot join
- intraoperative change of the surgical technique, surgical complications or complications occurring in the ICU, emergency reoperation, renal failure, failure to agree to continue in the study, presence of other types of heart disease, and presence of pulmonary diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perioperative Parameters to Predict Postoperative Respiratory Depression After Cardiac Surgery
Coronary artery bypass graft surgery (CABG) is associated with postoperative respiratory depression. In this study we aimed at investigating perioperative parameters that could predict the nadir of postoperative respiratory function impairment.
Read the detailed description
Coronary artery bypass graft (CABG) surgery is a principal revascularization option for ischemic heart disease and the principal modality for invasive treatment of coronary artery disease. Postoperative pulmonary complications are the most frequent and significant contributor to length of hospitalization, morbidity and mortality. The objective of this study is to search for perioperative parameters that could predict the degree of impairment of respiratory function after CABG with cardiopulmonary bypass (CPB).
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery bypass surgery, cardiopulmonary bypass, ICU, postoperative respiratory depression
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Respiratory Depression After Cardiac Surgery
Respiratory function is assessed through maximal inspiratory (MIP) and expiratory (MEP) pressures and peak expiratory flow (PEF) determined 1 day before surgery and one postoperative week.
Measured: 9 days
Secondary outcomes (2)
Intraoperative parameters after coronary artery bypass graft surgery (CABG)
Intraoperative parameters are monitored, including volume of cardioplegia, CPB duration, aortic cross-clamp time, number of grafts.
Measured: 1 day
Perioperative parameters after coronary artery bypass graft surgery (CABG)
ICU blood pressure is monitored
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2014 (estimated)
- Study startJan 2012
- Primary completionJun 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ovidiu Constantin Baltatu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ovidiu Constantin Baltatu, Universidade Camilo Castelo Branco
- Investigators
- Ovidiu C Baltatu, MD PhD, Study chair, Camilo Castelo Branco University (UNICASTELO)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02074371
- Sponsor's protocol ID
- BR-002-SJC
- Other IDs
- CEP-UESP128/11
- Acronym
- CABG PRD
- Status last verified
- Mar 2016
- First submitted
- 26 Feb 2014
- Last updated
- 30 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Costa AS, Costa PH, de Lima CE, Padua LE, Campos LA, Baltatu OC. ICU Blood Pressure Variability May Predict Nadir of Respiratory Depression After Coronary Artery Bypass Surgery. Front Neurosci. 2016 Jan 11;9:506. doi: 10.3389/fnins.2015.00506. eCollection 2015.
PubMed 26903799
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Parameters to Predict Postoperative Respiratory Depression After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02074371
- Acronym / sponsor ID
- CABG PRD / BR-002-SJC
- Conditions
- Coronary Artery Disease
- Keywords
- coronary artery bypass surgery, cardiopulmonary bypass, ICU, postoperative respiratory depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Ovidiu Constantin BaltatuUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 28 Feb 2014 (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.
Coronary artery bypass graft surgery (CABG) is associated with postoperative respiratory depression. In this study we aimed at investigating perioperative parameters that could predict the nadir of postoperative respiratory function impairment.
Detailed description
Coronary artery bypass graft (CABG) surgery is a principal revascularization option for ischemic heart disease and the principal modality for invasive treatment of coronary artery disease. Postoperative pulmonary complications are the most frequent and significant contributor to length of hospitalization, morbidity and mortality. The objective of this study is to search for perioperative parameters that could predict the degree of impairment of respiratory function after CABG with cardiopulmonary bypass (CPB).
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with coronary artery disease submitted to elective CABG with CPB.
Key inclusion criteria (1 listed)
- patients of both sexes older than 18 years submitted to CABG with CPB, presence of coronary disease confirmed by coronary angiography, use of the left internal thoracic artery and/or saphena, patients who remained in spontaneous ventilation on the first postoperative day, absence of chronic or acute pulmonary disease, and giving written informed consent to participate in the study.
Key exclusion criteria (1 listed)
- intraoperative change of the surgical technique, surgical complications or complications occurring in the ICU, emergency reoperation, renal failure, failure to agree to continue in the study, presence of other types of heart disease, and presence of pulmonary diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative Respiratory Depression After Cardiac Surgery
Time frame: 9 days
Respiratory function is assessed through maximal inspiratory (MIP) and expiratory (MEP) pressures and peak expiratory flow (PEF) determined 1 day before surgery and one postoperative week.
2 secondary outcomes
Intraoperative parameters after coronary artery bypass graft surgery (CABG)
Time frame: 1 day
Perioperative parameters after coronary artery bypass graft surgery (CABG)
Time frame: 3 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 30 Mar 2016.
- Derived from this study: PubMed 26903799Costa AS, Costa PH, de Lima CE, Padua LE, Campos LA, Baltatu OC. ICU Blood Pressure Variability May Predict Nadir of Respiratory Depression After Coronary Artery Bypass Surgery. Front Neurosci. 2016 Jan 11;9:506. doi: 10.3389/fnins.2015.00506. eCollection 2015.
- Published dataLink provided by the sponsor.
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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.
Ovidiu C Baltatu, MD PhD study chair
Camilo Castelo Branco University (UNICASTELO)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Ovidiu Constantin Baltatu 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 1 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 30 Mar 2016. 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?
Postoperative Respiratory Depression After Cardiac Surgery (time frame: 9 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02074371, which also lists 1 linked publication.
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 30 Mar 2016.