Postoperative Respiratory Depression After Cardiac Surgery (CABG PRD)

March 29, 2016 updated by: Ovidiu Constantin Baltatu

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

44

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Piauí
      • Teresina, Piauí, Brazil, 64001-280
        • Hospital Sao Marcos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with coronary artery disease submitted to elective CABG with CPB.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Crossover
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
9 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative parameters after coronary artery bypass graft surgery (CABG)
Time Frame: 1 day
Intraoperative parameters are monitored, including volume of cardioplegia, CPB duration, aortic cross-clamp time, number of grafts.
1 day
Perioperative parameters after coronary artery bypass graft surgery (CABG)
Time Frame: 3 days
ICU blood pressure is monitored
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ovidiu Constantin Baltatu

Investigators

  • Study Chair: Ovidiu C Baltatu, MD PhD, Camilo Castelo Branco University (UNICASTELO)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

February 26, 2014

First Submitted That Met QC Criteria

February 27, 2014

First Posted (Estimate)

February 28, 2014

Study Record Updates

Last Update Posted (Estimate)

March 30, 2016

Last Update Submitted That Met QC Criteria

March 29, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BR-002-SJC
  • CEP-UESP128/11 (Other Identifier: UESP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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