Postoperative Respiratory Depression After Cardiac Surgery (CABG PRD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ovidiu Constantin Baltatu, Universidade Castelo Branco
ClinicalTrials.gov Identifier:
NCT02074371
First received: February 26, 2014
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

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.


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Perioperative Parameters to Predict Postoperative Respiratory Depression After Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Universidade Castelo Branco:

Primary Outcome Measures:
  • Postoperative Respiratory Depression After Cardiac Surgery [ Time Frame: 9 days ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Intraoperative parameters after coronary artery bypass graft surgery (CABG) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Intraoperative parameters are monitored, including volume of cardioplegia, CPB duration, aortic cross-clamp time, number of grafts.

  • Perioperative parameters after coronary artery bypass graft surgery (CABG) [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    ICU blood pressure is monitored


Enrollment: 44
Study Start Date: January 2012
Study Completion Date: November 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02074371

Locations
Brazil
Hospital Sao Marcos
Teresina, Piauí, Brazil, 64001-280
Sponsors and Collaborators
Ovidiu Constantin Baltatu
Investigators
Study Chair: Ovidiu C Baltatu, MD PhD Camilo Castelo Branco University (UNICASTELO)
  More Information

No publications provided

Responsible Party: Ovidiu Constantin Baltatu, Professor, Universidade Castelo Branco
ClinicalTrials.gov Identifier: NCT02074371     History of Changes
Other Study ID Numbers: BR-002-SJC, CEP-UESP128/11
Study First Received: February 26, 2014
Last Updated: February 27, 2014
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Universidade Castelo Branco:
coronary artery bypass surgery
cardiopulmonary bypass
ICU
postoperative respiratory depression

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Depression
Depressive Disorder
Respiratory Insufficiency
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 28, 2014