Effects of Conventional Physiotherapy and Thoracoabdominal Rebalancing in Post-operative of Myocardial Revascularization

NCT04631198 | Completed

• 1 other identifier: 5818/20
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

When it comes to cardiovascular diseases, surgical or clinical treatment can be cited, and cardiac surgery is considered a complex and large treatment where it involves important organic repercussions that alter the physiological and hemodynamic mechanisms of patients, which can lead to a critical state postoperatively, leading to possible complications that require intensive care at that time. Respiratory complications usually occur frequently in the postoperative period of these surgeries, causing a functional lung capacity to decrease by up to 20%, which may result in atelectasis, pneumonia, pleural effusion, among others. For this reason, physiotherapy usually plays an important role in the treatment of these patients, as it helps to reduce or treat these complications, in addition to promoting motor rehabilitation of patients before myocardial revascularization surgery. For this reason, this study aims to compare the effect of conventional physiotherapy techniques with the management of thoracoabdominal rebalancing in postoperative patients of coronary artery bypass graft. This is a randomized pilot trial in which patients who underwent coronary artery bypass surgery at the Institute of Cardiology of Rio Grande do Sul participate in the study. Patients selected for the control group (conventional physiotherapy) will be exposed to respiratory physiotherapy techniques such as vibrocompression, passive manual expiratory therapy, acceleration of expiratory flow, fractional inspiration in times, diaphragmatic breaths and aspiration when necessary, and patients selected for the intervention group, will appear on the management of thoracoabdominal rebalancing as abdominal supports and / or in the ileo-costal space, inspiratory aid, release of the scapular waist, thoracic swing, release of the pectoralis major and deltoid muscles together with aspiration, if necessary.

Conditions

Respiratory Complication

Keywords

Myocardial revascularization surgery; Physical therapy

Outcome Measures

Primary Outcomes (1)

• Change in Downes and Raphaelly respiratory distress scale

  Points 0-10, where 0 is better and 10 is worse

  Immediately before and after 20 minutes

Secondary Outcomes (5)

• respiratory rate

  Immediately before and after 20 minutes

• peripheral saturation

  Immediately before and after 20 minutes

• mean blood pressure

  Immediately before and after 20 minutes

• Pulmonary auscultation assessment

  Immediately before and after 20 minutes

• heart rate

  Immediately before and after 20 minutes

Study Arms (2)

No Intervention: GROUP CONTROL

NO INTERVENTION

Patients selected for the control group (conventional physiotherapy) will be exposed to respiratory physiotherapy techniques such as vibrocompression, manual passive expiratory therapy, expiratory flow acceleration, fractional inspiration in times, diaphragmatic breaths and aspiration when required

Active Comparator: INTERVENTION GROUP

EXPERIMENTAL

The patients selected for the intervention group will be submitted to the handling of thoracoabdominal rebalancing as abdominal supports and / or in the ileo-costal space, inspiratory help, scapular waist release, thoracic swing, pectoralis major muscle release and deltoid together with aspiration if necessary.

Other: Thoracoabdominal rebalancing

Interventions

Thoracoabdominal rebalancing OTHER

the patients selected for the intervention group will be submitted to the handling of thoracoabdominal rebalancing as abdominal supports and / or in the ileo-costal space, inspiratory help, scapular waist release, thoracic swing, pectoralis major muscle release and deltoid together with aspiration if necessary.

Active Comparator: INTERVENTION GROUP

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The study will include individuals over 35 years of age who have undergone myocardial revascularization surgery surgery with prescribed physiotherapeutic treatment.

You may not qualify if:

• Patients who are intubated and / or remained on mechanical ventilation for more than 48 hours or who needed non-invasive mechanical ventilation before or during the collection period will be excluded.

Sponsors & Collaborators

• Instituto de Cardiologia do Rio Grande do Sul: lead

Study Sites (1)

Karolini Reis Branco

Porto Alegre, 90620000, Brazil

Location

Related Publications (3)

• Hulzebos EH, Van Meeteren NL, De Bie RA, Dagnelie PC, Helders PJ. Prediction of postoperative pulmonary complications on the basis of preoperative risk factors in patients who had undergone coronary artery bypass graft surgery. Phys Ther. 2003 Jan;83(1):8-16.

  PMID: 12495408 BACKGROUND

• Cordeiro AM, Souza DC, Quinzani RH, Troster EJ. [Comparison between an upper airway obstruction score and airway endoscopy to detect airway injury associated with endotracheal intubation in children]. J Pediatr (Rio J). 2003 Nov-Dec;79(6):543-9. Portuguese.

  PMID: 14685453 BACKGROUND

• Cavenaghi S, Ferreira LL, Marino LH, Lamari NM. Respiratory physiotherapy in the pre and postoperative myocardial revascularization surgery. Rev Bras Cir Cardiovasc. 2011 Jul-Sep;26(3):455-61. doi: 10.5935/1678-9741.20110022. English, Portuguese.

  PMID: 22086584 BACKGROUND

Study Officials

• Bruna Eibel, PhD

  Instituto de Cardiologia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a pilot randomized clinical trial. The randomization technique for proposed proposals will be performed using a computer program (www.random.org) containing the coded distribution. The allocation confidentiality will be guaranteed by a randomization list that will be in a remote place, which will prevent the researcher from identifying which intervention will be specified by each patient. The generation of the sequence of numbers will be performed by a researcher "blind" to the study, after selection of the patients by the inclusion criteria. The sequence of numbers one used for randomization will be kept confidential until the exact moment of the beginning of the study. The randomization of the subjects in the proposed groups will be done in two blocks, in which the program will randomly distribute each new participant to one of the blocks: conventional physical therapy group and thoracoabdominal rebalancing group.

Study Record Dates

• First Submitted: October 19, 2020
• First Posted: November 17, 2020
• Study Start: July 20, 2020
• Primary Completion: February 10, 2022
• Study Completion: December 10, 2022
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)