Clinical trial NCT06814951: Acute Effect of the Thoraco-abdominal Rebalance Method on Diaphragmatic Function, Respiratory Discomfort, Pulmonary Complications and Hemodynamic Variables in Postoperative Cardiac Surgery Patients
Official title: Acute Effect of the Thoraco-abdominal Rebalance Method on Diaphragmatic Function, Respiratory Discomfort, Pulmonary Complications and Hemodynamic Variables in Postoperative Cardiac Surgery Patients: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Respiratory Complications
Diaphragmatic Excursion
Pulmonary Spirometry
Keywords: Physiotherapy
Ultrasonography
Cardiology
Lead sponsor: Instituto de Cardiologia do Rio Grande do Sul
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 8
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: The randomization technique for the proposed interventions 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 kept in a remote location, which will prevent the researcher from identifying which intervention will be initiated by each patient. The generation of the sequence of numbers will be performed by a blinded researcher, after selecting the patients according to the inclusion criteria. The sequence of numbers to be 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 physiotherapy group and RTA group.
Primary purpose: TREATMENT

Brief summary: Introduction: The thoracoabdominal rebalancing (TAR) method aims to promote diaphragmatic juxtaposition, in addition to seeking to increase respiratory muscle strength and adjust muscle tone. However, scientific publications on this method in heart patients undergoing coronary artery bypass grafting (CABG) are still scarce, justifying the need to carry out this study for information, evaluation, diagnosis and treatment purposes in the health area with an emphasis on cardiology.

Objective: To evaluate whether diaphragmatic ultrasound findings differ between the TAR method and conventional physiotherapy in post-CABG patients.

Methods: This is a randomized, single-blind clinical trial. Adults (\>35 years), hemodynamically stable, who underwent CABG (\<24 hours) and had a prescription for physiotherapy will be included. Patients will be randomized into two groups: 1) intervention group \[IG\] - TAR; 2) control group \[CG\] - standard physiotherapy approach. Interventions will be performed at a single time and the following variables will be collected pre- and post-intervention: heart rate (HR), respiratory rate (RR), peripheral oxygen saturation (SpO2), mean arterial pressure (MAP), diaphragmatic ultrasound (US) to identify possible acute findings in both groups, respiratory distress scale and pulmonary complications scale will be applied at the end of the interventions.

Keywords: Physiotherapy; Cardiology; Ultrasonography

Detailed description: To compare the effect of conventional physiotherapy techniques with the management of thoracoabdominal rebalancing in postoperative patients after myocardial revascularization surgery, carefully evaluating these effects through diaphragm ultrasound and pulmonary spirometry, in addition to variables such as vital signs and respiratory distress scales and pulmonary complications after cardiac surgery. This is a randomized trial in which patients undergoing myocardial revascularization surgery at the Cardiology Institute of Rio Grande do Sul will participate.

Individuals over 35 years of age who underwent myocardial revascularization surgery with prescribed physiotherapy treatment will be included in the study. Patients who were intubated and/or remained on mechanical ventilation for more than twelve hours or who required non-invasive mechanical ventilation before or during the collection period will be excluded.

The study was submitted to the Research Ethics Committee of the Cardiology Institute of Porto Alegre (CEP-ICFUC). All study participants will receive clear explanations about the research, and those who voluntarily agree to participate in the study will sign the informed consent form in two copies, one of which will be made available to the participant and the other to the researchers. Participants will not be paid, nor will they receive any assistance during or after the end of the research (466/12).

The benefits of this research will be in improved conduct that prevents or reduces complications and/or respiratory discomfort, as well as speeding up the patient's recovery, aiming for faster hospital discharge. 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 breathing and aspiration when necessary, and patients selected for group intervention will undergo thoracoabdominal rebalancing management such as abdominal supports and/or in the ileocostal space, inspiratory assistance, release of the shoulder girdle, thoracic swing, release of the pectoralis major and deltoid muscles together with aspiration if necessary.

The research presents minimal risks for the participants, which are related to the measurement of hemodynamic variables through the monitor, in addition to the pulmonary spirometry test and diaphragmatic analysis through ultrasound, and/or application of conventional physiotherapy techniques such as vibrocompression, acceleration of expiratory flow, passive manual expiratory therapy that may suggest some discomfort or pain when touching the chest in a sensation of pressure and vibration. Patients undergoing thoracoabdominal rebalancing treatment are expected to have lower scores on the pulmonary complications scale, Downes and Raphaelly respiratory distress scale and, consequently, better diaphragmatic excursion, as well as improvements in other variables.

Eligibility criteria: Inclusion Criteria:

* Individuals over 35 years of age who undergo coronary artery bypass graft surgery with prescribed physiotherapy treatment will be included in the study.

Exclusion Criteria:

* Patients who are intubated and/or have remained on mechanical ventilation for more than twelve hours, or who require non-invasive mechanical ventilation (NIV) before or during the collection period will be excluded.

Primary outcomes:
measure: Diaphragmatic excursion
timeFrame: Immediately before the intervention and within 30 minutes after the intervention
measure: Change in the Downes and Raphaelly respiratory distress scale
timeFrame: Immediately before the intervention and within 30 minutes after the intervention
measure: Pulmonary spirometry
timeFrame: Immediately before the intervention and within 30 minutes after the intervention
measure: Pulmonary spirometry
timeFrame: Immediately before the intervention and within 30 minutes after the intervention
measure: Pulmonary spirometry
timeFrame: Immediately before the intervention and within 30 minutes after the intervention
measure: Pulmonary spirometry
timeFrame: Immediately before the intervention and within 30 minutes after the intervention
Secondary outcomes:
measure: Respiratory rate
timeFrame: Immediately before the intervention and within 30 minutes after the intervention
measure: Peripheral oxygen saturation
timeFrame: Immediately before the intervention and within 30 minutes after the intervention
measure: Mean arterial pressure
timeFrame: Immediately before the intervention and within 30 minutes after the intervention
measure: Lung auscultation assessment
timeFrame: Immediately before the intervention and within 30 minutes after the intervention
measure: Heart rate
timeFrame: Immediately before the intervention and within 30 minutes after the intervention
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Intituto de Cardiologia do Rio Grande do Sul
state: Rio Grande Do Sul
Study officials:
affiliation: Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre, Brasil
name: Instituto de Cardiologia do Rio Grande do Sul
role: PRINCIPAL_INVESTIGATOR
References:
citation: SANTANA, Pauliane Vieira et al. Ultrassonografia diafragmática: uma revisão de seus aspectos metodológicos e usos clínicos. Jornal Brasileiro de Pneumologia, v. 46, 2020.
citation: 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.
citation: OLIVEIRA, Miriana Carvalho; SOBRINHO, Cristina Ortiz; ORSINI, Marco. Comparação entre o método Reequilíbrio Toracoabdominal e a fisioterapia respiratória convencional em recém-nascidos com taquipneia transitória: um ensaio clínico randomizado. Fisioterapia Brasil, v. 18, n. 5, p. 598-607, 2018
citation: SOARES, Jainy Lima; DE SOUSA, Anderson Moura Bonfim; DA SILVA MEDEIROS, Joelson. Physiotherapy treatment in the pre and postoperative period of cardiac surgery: an integrative review. Revista Ciência & Saberes-Facema, v. 3, n. 3, p. 624-629, 2017.
citation: SANTANA, Vilma Maria et al. Health Education for Patients in the Perioperative Period of Cardiovascular Surgery: Experience Report. Brazilian Journal of Health Review, v. 4, n. 2, p. 5559-5571, 2021.
citation: 1. BECCARIA, Lucia Marinilza et al. Postoperative complications in patients undergoing cardiac surgery in a teaching hospital. Archives of Health Sciences, v. 22, n. 3, p. 37-41, 2015.