Postoperative Respiratory Depression After Cardiac Surgery

Coronary Artery Disease Clinical Trial

— CABG PRD  

Official title:

Perioperative Parameters to Predict Postoperative Respiratory Depression After Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02074371
• Other study ID #: BR-002-SJC
• Secondary ID: CEP-UESP128/11
• Status: Completed
• Phase: N/A
• First received: February 26, 2014
• Last updated: March 29, 2016
• Start date: January 2012
• Est. completion date: November 2012

Study information

• Verified date: March 2016
• Source: Universidade Camilo Castelo Branco
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: November 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Respiratory Insufficiency

Locations

Country	Name	City	State
Brazil	Hospital Sao Marcos	Teresina	Piauí

Sponsors (1)

Lead Sponsor	Collaborator
Ovidiu Constantin Baltatu

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	9 days	No
Secondary	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.	1 day	No
Secondary	Perioperative parameters after coronary artery bypass graft surgery (CABG)	ICU blood pressure is monitored	3 days	No

External Links

•   Published data