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Postoperative Respiratory Depression After Cardiac Surgery (CABG PRD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02074371
First Posted: February 28, 2014
Last Update Posted: March 30, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ovidiu Constantin Baltatu, Universidade Camilo Castelo Branco
  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 Ovidiu Constantin Baltatu, Universidade Camilo Castelo Branco:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.

  • Perioperative parameters after coronary artery bypass graft surgery (CABG) [ Time Frame: 3 days ]
    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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ovidiu Constantin Baltatu, Professor, Universidade Camilo Castelo Branco
ClinicalTrials.gov Identifier: NCT02074371     History of Changes
Other Study ID Numbers: BR-002-SJC
CEP-UESP128/11 ( Other Identifier: UESP )
First Submitted: February 26, 2014
First Posted: February 28, 2014
Last Update Posted: March 30, 2016
Last Verified: March 2016

Keywords provided by Ovidiu Constantin Baltatu, Universidade Camilo Castelo Branco:
coronary artery bypass surgery
cardiopulmonary bypass
ICU
postoperative respiratory depression

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