NCT02074371

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 28, 2014

Completed
Last Updated

March 30, 2016

Status Verified

March 1, 2016

Enrollment Period

5 months

First QC Date

February 26, 2014

Last Update Submit

March 29, 2016

Conditions

Keywords

coronary artery bypass surgerycardiopulmonary bypassICUpostoperative respiratory depression

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Intraoperative parameters after coronary artery bypass graft surgery (CABG)

    1 day

  • Perioperative parameters after coronary artery bypass graft surgery (CABG)

    3 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Sao Marcos

Teresina, Piauí, 64001-280, Brazil

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Ovidiu C Baltatu, MD PhD

    Camilo Castelo Branco University (UNICASTELO)

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 26, 2014

First Posted

February 28, 2014

Study Start

January 1, 2012

Primary Completion

June 1, 2012

Study Completion

November 1, 2012

Last Updated

March 30, 2016

Record last verified: 2016-03

Locations