Postoperative; Dysfunction Following Cardiac Surgery Clinical Trial
Official title:
Impact of an Early Mobilization Program on Functional Capacity After Coronary Artery Bypass Surgery: a Protocol of Randomized Controlled Trial.
NCT number | NCT02312648 |
Other study ID # | UNICID |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2015 |
Est. completion date | November 2016 |
Verified date | June 2018 |
Source | Universidade Cidade de Sao Paulo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of this study is to investigate the effects of a program of early mobilization in the functional capacity in patients undergoing coronary artery bypass grafting in short and long- term.
Status | Completed |
Enrollment | 52 |
Est. completion date | November 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 90 Years |
Eligibility |
Inclusion Criteria: - Consecutive patients admitted to elective and conventional coronary artery bypass, Body Mass Index (BMI) between 20 and 30 Kg/m2, mechanical ventilation time under than 24 hours, hemodynamic stability with or without use of positive inotropes, absence of arrhythmias and angina, mean arterial pressure (MAP) 60<PAM<100 mmHg, heart frequency (HR) 60<FC<100 bpm without signs of respiratory distress such as flaring nose, use of accessory muscles, thoracoabdominal asynchrony, respiratory frequency (f) = 20 bpm without signs of infection were included in this study. Exclusion Criteria: - : presence of previous pulmonary disease, ejection fraction under 35% or longer than 54%, reoperation, intraoperative death or any contraindications to perform the proposed measurements and/or treatment. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Luciana Chiavegato |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Functional Capacity | Patients will be submitted to six minute walking test | All patients will be evaluated on preoperative period ( when they arrived in the hospital to do the surgery), hospital discharge ( about a mean of two weeks afeter surgery) and 60 postoperative days in cargiology ambulatory | |
Secondary | Intensive Care Unit (ICU) and Hospital length of stay | The number the days in ICU and hospital until discharge will be counted for each patient | All patients will be followed for the duration of hospital stay, an expected average of 30 days | |
Secondary | Postoperative pulmonary complication (PPC) | The occurrence of PPC will be monitored until the day of hospital discharge by a physician blinded to the groups: pneumonia (chest radiography with pulmonary infiltrate associated with two of the following signs: purulent expectoration, temperature above 38.3ยบ C and a greater than 25% increase in baseline leukocyte count with hyperthermia), atelectasis (RS associated with abnormal chest acute respiratory symptoms), hypoxemia (peripheral oxygen saturation associated with respiratory symptoms below 85%). | All patients will be followed for the duration of hospital stay, an expected average of 30 days |
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