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

August 13, 2015 updated by: Emilia Nozawa, PT PhD, University of Sao Paulo General Hospital

Study of Impact of Three Body Positioning Strategies in the Drainage Fluids in the Immediate Postoperative Period in Patients After Coronary Artery Bypass Surgery

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

101

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Active Comparator: 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.
Other: 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.
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
volume of drainage fluids
Time Frame: 48 hours
measure of volume of drainage fluids (mililiter) pre and post intervention until extract the mediastinal and/or thoracic tube
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
score of pulmonary complications
Time Frame: 7 days
incidence of postoperative pulmonary complications, was scored by a blinded independent investigator on an ordinal scale of 1 to 4
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Investigators

  • Study Director: Filomena G Gallas, PHD, University of Sao Paulo
  • Study Chair: Ludhmila A Hajjar, PHD, University of Sao Paulo Medical School
  • Study Director: Maria Ignêz Z Feltrim, PHD, Heart Intsitute (InCor) Hospital das Clinicas - FMUSP
  • Study Chair: Camila CM Buzzeto, PT, Heart Institute (InCor) Hospital das Clinicas - FMUSP
  • Study Chair: Vera RM Coimbra, PT, Heart Institute (InCor) Hospital das Clinicas _ FMUSP
  • Study Chair: Adriano RB Rodrigues, Nursing, Heart Intitute (InCor) Hospital das Clinicas _ FMUSP
  • Study Chair: Cristiane D Gonçalves, PT, Heart Intitute (InCor) Hospital das Clinicas _ FMUSP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

July 20, 2015

First Submitted That Met QC Criteria

August 13, 2015

First Posted (Estimate)

August 17, 2015

Study Record Updates

Last Update Posted (Estimate)

August 17, 2015

Last Update Submitted That Met QC Criteria

August 13, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 141372

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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