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

NCT ID: NCT02525289

Last Updated: 2015-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2015-06-30

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control Group

six hours after extubation receiving breathing exercises. After 48 hour postoperative time, sitting on armchair and keeping the erect position and walking in the same place.

Group Type: NO_INTERVENTION

No interventions assigned to this 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.

Group Type: ACTIVE_COMPARATOR

Bed Rotation Group

Intervention Type: OTHER

Patients received continuous lateral rotation by a mechanical device (Hill Rom Bed Rotation), consecutive cycles of to left and right side, plus supine position during 30 seconds for pause, in the first postoperative day until 48 hours. Additional breathing exercises.

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.

Group Type: ACTIVE_COMPARATOR

Orthostatic Group

Intervention Type: OTHER

Patients were seated on the bed 6 hours post extubation for two hours. After, sitting in the bed with their feet on the floor for two minutes; standing up and walking in the place for two minutes, in the first 24 hours and 48 hours postoperative. Additional breathing exercises.

Interventions

Bed Rotation Group

Patients received continuous lateral rotation by a mechanical device (Hill Rom Bed Rotation), consecutive cycles of to left and right side, plus supine position during 30 seconds for pause, in the first postoperative day until 48 hours. Additional breathing exercises.

Intervention Type: OTHER

Orthostatic Group

Patients were seated on the bed 6 hours post extubation for two hours. After, sitting in the bed with their feet on the floor for two minutes; standing up and walking in the place for two minutes, in the first 24 hours and 48 hours postoperative. Additional breathing exercises.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Emilia Nozawa, PT PhD

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Filomena G Gallas, PHD

Role: STUDY_DIRECTOR

University of Sao Paulo

Ludhmila A Hajjar, PHD

Role: STUDY_CHAIR

University of Sao Paulo Medical School

Maria Ignêz Z Feltrim, PHD

Role: STUDY_DIRECTOR

Heart Intsitute (InCor) Hospital das Clinicas - FMUSP

Camila CM Buzzeto, PT

Role: STUDY_CHAIR

Heart Institute (InCor) Hospital das Clinicas - FMUSP

Vera RM Coimbra, PT

Role: STUDY_CHAIR

Heart Institute (InCor) Hospital das Clinicas _ FMUSP

Adriano RB Rodrigues, Nursing

Role: STUDY_CHAIR

Heart Intitute (InCor) Hospital das Clinicas _ FMUSP

Cristiane D Gonçalves, PT

Role: STUDY_CHAIR

Heart Intitute (InCor) Hospital das Clinicas _ FMUSP

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Other Identifiers

141372

Identifier Type: -

Identifier Source: org_study_id