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Coronary Artery DiseasePhase 1positioningNCT02525289

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

A Phase 1 study testing Bed Rotation Group and Orthostatic Group in people with Coronary Artery Disease, run by University of Sao Paulo General Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Coronary Artery Disease
What is being tested?
Bed Rotation Group and Orthostatic Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
101 participants
Where
No sites listed yet
Study dates
Nov 2012to Jun 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

About this study

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

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).

Read the 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.

Being tested
Bed Rotation Group, Orthostatic Group
Keywords
mobility, coronary artery bypass, positioning, body
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bed Rotation GroupOther

    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 GroupOther

    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.

Study groups in NCT02525289
Study groupRoleWhat they receive
Control GroupNo interventionsix 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 GroupActive comparatorsix hours after extubation receiving breathing exercises and submitted the continuous rotational bed therapy in the first postoperative day until 48 hours.
Receives: Other: Bed Rotation Group
Orthostatic GroupActive comparatorsix 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.
Receives: Other: Orthostatic Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. volume of drainage fluids

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

    Measured: 48 hours

Secondary outcomes (1)

  1. score of pulmonary complications

    incidence of postoperative pulmonary complications, was scored by a blinded independent investigator on an ordinal scale of 1 to 4

    Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2015 (estimated)
  2. Study startNov 2012
  3. Primary completionDec 2013
  4. Study completionJun 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Single blind
Who is masked
Participant
Enrolment
101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02525289
Sponsor's protocol ID
141372
Acronym
positioning
Status last verified
Aug 2015
First submitted
20 Jul 2015
Last updated
17 Aug 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 16146459

  • 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.

    PubMed 17192526

  • 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.

    PubMed 17047215

  • 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.

    PubMed 18596631

  • 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.

    PubMed 19234100

  • 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.

    PubMed 12352030

  • 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.

    PubMed 6839822

  • 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.

    PubMed 22414416

  • 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.

    PubMed 22666720

  • 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.

    PubMed 15470853

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

    PubMed 22807649

  • 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.

    PubMed 14742360

  • 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.

    PubMed 1580723

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Bed Rotation Group and Orthostatic Group in people with Coronary Artery Disease, run by University of Sao Paulo General Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

volume of drainage fluids (time frame: 48 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02525289, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2015.

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