Clinical trial NCT02525289: Impact of Three Body Positioning Strategies in the Drainage Fluids After Coronary Artery Bypass Surgery
Official title: Study of Impact of Three Body Positioning Strategies in the Drainage Fluids in the Immediate Postoperative Period in Patients After Coronary Artery Bypass Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Coronary Artery Disease
Keywords: mobility
coronary artery bypass
positioning
body
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2015-08-17
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To investigate different strategies of body positioning associated to early corporal mobilization and verify the impact int the time and quantification of thoracic and mediastinal drainage, pulmonary complications and time of intensive care units in hospitals stay. After first six hours post extubation in the first postoperative day and after evaluation and inclusion in the study, patients were randomized in three groups for receiving different strategies of body positioning associated to early mobilization with help of bed Hill Rom (Hill Rom Batesville@): Group 1: Control (GC n=33); Group 2: Continuous Lateral Rotation Group (TRCL n=34); Group 3:Positioning in sitting and Orthostatic (ORT n=34).

Detailed description: Coronary artery bypass surgery can lead to pulmonary complications like pleural effusion and pneumonia. These complications increase the length of stay and the immobility time. The investigators aim was to assess the impact of early mobilization of fluids drainage of chest tubes and the incidence of pulmonary complications. A prospective, randomized study included 101 patients divided in three groups. In the Control Group (CG:n=33) the patients were seated in armchair in the first 48 hours postoperative time. The Group (TRCL n=34) a Continuous Rotational Bed Therapy was instituted six hours post extubation in the first 24 hours and it comprised with by consecutive cycles of lateral rotation to the left and right side, and supine position with 30 seconds for pauses (using a Hill Rom Rotational Bed Device) witch stopped when need to perform routine measurements the hemodynamics measurements and clinical controls by nursing crew.The group ( ORT n=33) following the sequential steps T1: sitting in the bed for 2 hours, T2: sitting on the bed with their feet on the floor for 2 minutes and T3: the patients stoos up and walked on the spot for 2 minutes. Hemodynamics and oxygenation measurement before and after each intervention.

Eligibility criteria: Inclusion Criteria:

* first postoperative day of cardiovascular surgery 6 hours after extubation
* EFVE\> 35%
* writen inform consent

Exclusion Criteria:

* neurological alteration
* hemodynamics instability with PAM \< 60 mmHg
* blood
* pneumothorax or broncopleural
* arritymias

Primary outcomes:
measure: volume of drainage fluids
timeFrame: 48 hours
Secondary outcomes:
measure: score of pulmonary complications
timeFrame: 7 days
Other outcomes:
Locations:
Study officials:
affiliation: University of Sao Paulo
name: Filomena G Gallas, PHD
role: STUDY_DIRECTOR
affiliation: University of Sao Paulo Medical School
name: Ludhmila A Hajjar, PHD
role: STUDY_CHAIR
affiliation: Heart Intsitute (InCor) Hospital das Clinicas - FMUSP
name: Maria Ignêz Z Feltrim, PHD
role: STUDY_DIRECTOR
affiliation: Heart Institute (InCor) Hospital das Clinicas - FMUSP
name: Camila CM Buzzeto, PT
role: STUDY_CHAIR
affiliation: Heart Institute (InCor) Hospital das Clinicas _ FMUSP
name: Vera RM Coimbra, PT
role: STUDY_CHAIR
affiliation: Heart Intitute (InCor) Hospital das Clinicas _ FMUSP
name: Adriano RB Rodrigues, Nursing
role: STUDY_CHAIR
affiliation: Heart Intitute (InCor) Hospital das Clinicas _ FMUSP
name: Cristiane D Gonçalves, PT
role: STUDY_CHAIR
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