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

NCT02525289 | Completed Phase 1 DMC

• 1 other identifier: 141372
• Study Type: interventional
• Target: 101
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Coronary Artery Disease

Keywords

mobility; coronary artery bypass; positioning; body

Outcome Measures

Primary Outcomes (1)

• volume of drainage fluids

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

  48 hours

Secondary Outcomes (1)

• score of pulmonary complications

  7 days

Study Arms (3)

Control Group

NO INTERVENTION

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.

Bed Rotation Group

ACTIVE COMPARATOR

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

Orthostatic Group

ACTIVE COMPARATOR

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

Interventions

Bed Rotation Group 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.

Bed Rotation Group

Orthostatic Group 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.

Orthostatic Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Related Publications (13)

• Kirkeby-Garstad I, Stenseth R, Sellevold OF. Post-operative myocardial dysfunction does not affect the physiological response to early mobilization after coronary artery bypass grafting. Acta Anaesthesiol Scand. 2005 Oct;49(9):1241-7. doi: 10.1111/j.1399-6576.2005.00854.x.

  PMID: 16146459 RESULT

• Goldhill DR, Imhoff M, McLean B, Waldmann C. Rotational bed therapy to prevent and treat respiratory complications: a review and meta-analysis. Am J Crit Care. 2007 Jan;16(1):50-61; quiz 62.

  PMID: 17192526 RESULT

• Hulzebos EH, Helders PJ, Favie NJ, De Bie RA, Brutel de la Riviere A, Van Meeteren NL. Preoperative intensive inspiratory muscle training to prevent postoperative pulmonary complications in high-risk patients undergoing CABG surgery: a randomized clinical trial. JAMA. 2006 Oct 18;296(15):1851-7. doi: 10.1001/jama.296.15.1851.

  PMID: 17047215 RESULT

• Morris PE, Goad A, Thompson C, Taylor K, Harry B, Passmore L, Ross A, Anderson L, Baker S, Sanchez M, Penley L, Howard A, Dixon L, Leach S, Small R, Hite RD, Haponik E. Early intensive care unit mobility therapy in the treatment of acute respiratory failure. Crit Care Med. 2008 Aug;36(8):2238-43. doi: 10.1097/CCM.0b013e318180b90e.

  PMID: 18596631 RESULT

• Perme C, Chandrashekar R. Early mobility and walking program for patients in intensive care units: creating a standard of care. Am J Crit Care. 2009 May;18(3):212-21. doi: 10.4037/ajcc2009598. Epub 2009 Feb 20.

  PMID: 19234100 RESULT

• Kirschenbaum L, Azzi E, Sfeir T, Tietjen P, Astiz M. Effect of continuous lateral rotational therapy on the prevalence of ventilator-associated pneumonia in patients requiring long-term ventilatory care. Crit Care Med. 2002 Sep;30(9):1983-6. doi: 10.1097/00003246-200209000-00006.

  PMID: 12352030 RESULT

• Sonnenblick M, Melzer E, Rosin AJ. Body positional effect on gas exchange in unilateral pleural effusion. Chest. 1983 May;83(5):784-6. doi: 10.1378/chest.83.5.784.

  PMID: 6839822 RESULT

• Sachdev G, Napolitano LM. Postoperative pulmonary complications: pneumonia and acute respiratory failure. Surg Clin North Am. 2012 Apr;92(2):321-44, ix. doi: 10.1016/j.suc.2012.01.013.

  PMID: 22414416 RESULT

• Mirmohammad-Sadeghi M, Etesampour A, Gharipour M, Shariat Z, Nilforoush P, Saeidi M, Mackie M, Sadeghi FM. Early chest tube removal after coronary artery bypass graft surgery. N Am J Med Sci. 2009 Dec;1(7):333-7. doi: 10.4297/najms.2009.7333.

  PMID: 22666720 RESULT

• Ahrens T, Kollef M, Stewart J, Shannon W. Effect of kinetic therapy on pulmonary complications. Am J Crit Care. 2004 Sep;13(5):376-83.

  PMID: 15470853 RESULT

• Adler J, Malone D. Early mobilization in the intensive care unit: a systematic review. Cardiopulm Phys Ther J. 2012 Mar;23(1):5-13.

  PMID: 22807649 RESULT

• Kirkeby-Garstad I, Sellevold OFM, Stenseth R, Skogvoll E, Karevold A. Marked mixed venous desaturation during early mobilization after aortic valve surgery. Anesth Analg. 2004 Feb;98(2):311-317. doi: 10.1213/01.ANE.0000096194.10459.7E.

  PMID: 14742360 RESULT

• Kroenke K, Lawrence VA, Theroux JF, Tuley MR. Operative risk in patients with severe obstructive pulmonary disease. Arch Intern Med. 1992 May;152(5):967-71.

  PMID: 1580723 RESULT

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Filomena G Gallas, PHD

  University of Sao Paulo

  STUDY DIRECTOR

• Ludhmila A Hajjar, PHD

  University of Sao Paulo Medical School

  STUDY CHAIR

• Maria Ignêz Z Feltrim, PHD

  Heart Intsitute (InCor) Hospital das Clinicas - FMUSP

  STUDY DIRECTOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: July 20, 2015
• First Posted: August 17, 2015
• Study Start: November 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: June 1, 2015
• Last Updated: August 17, 2015

Record last verified: 2015-08