Impact of Three Body Positioning Strategies in the Drainage Fluids After Coronary Artery Bypass Surgery

Phase 1

Completed

• Conditions: Coronary Artery Disease
• Interventions: Other: Bed Rotation Group; Other: Orthostatic Group

• Registration Number: NCT02525289
• Lead Sponsor: University of Sao Paulo General Hospital

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.

Study Timeline

• Study Start: 2012-11
• Primary Completion: 2013-12
• Study Completion: 2015-06
• Study First Submitted: 2015-07-20
• Status Verified: 2015-08
• Study First Submitted QC: 2015-08-13
• Last Update Submitted: 2015-08-13
• Study First Posted: 2015-08-17
• Last Update Posted: 2015-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bed Rotation Group	Bed Rotation Group	six hours after extubation receiving breathing exercises and submitted the continuous rotational bed therapy in the first postoperative day until 48 hours.
Orthostatic Group	Orthostatic Group	six hours after extubation receiving breathing exercises and changing the body position following the sequence: sitting on the bed, sitting on the bed with the feet on the floor , standing and walking in the same place, in the first postoperative day until 48 hours.

Primary Outcome Measures

Name	Time	Method
volume of drainage fluids	48 hours	measure of volume of drainage fluids (mililiter) pre and post intervention until extract the mediastinal and/or thoracic tube

Secondary Outcome Measures

Name	Time	Method
score of pulmonary complications	7 days	incidence of postoperative pulmonary complications, was scored by a blinded independent investigator on an ordinal scale of 1 to 4