Effects of Non-invasive Ventilation in Patients Undergoing Heart Surgery

Summary

The goal of this randomized controlled clinical trial is to compare effects of non-invasive ventilation with different modalities (notably CPAP and BIPAP) in patients undergoing heart surgery. The main question\[s\] it aims to answer are:

* Which NIV ventilation mode is most effective in cardiac surgery patients?
* Is there a big difference between conventional physiotherapy treatment and the use of NIV in these patients? Participants will be submited in the intervention will initially take place in the specific ward that receives patients in the postoperative period of cardiac surgery. Participants will be recruited after the patient is hospitalized the day before the surgery, during which time he will undergo a preoperative evaluation based on the study criteria. On that first day, the evaluation will consist of anamnesis and physical examination, focusing on the history of cardiac disorders, followed by measurements inherent to the protocol. Manovacuometry, chest X-ray, quality of life questionnaire, walk test and spirometry. The evaluation can be carried out in two stages, if there are other demands for the patient during his hospitalization.

Researchers will compare three groups: 1 - cpap group - CPAP + usual physical therapy care, 2 - Bipap group - BIPAP + usual physical therapy care and 3 - Control - usual physical therapy care), in the 1:1 allocation ratio and superiority. to see if the effects of non-invasive ventilation with different modalities in patients undergoing cardiac surgery demonstrates some superior way in clinical practice. The observed outcomes will be: evaluation between NIV modalities, spirometry, lung capacity and vital signs. Secondary outcomes included are degree of satisfaction with the global perception of change scale, and MIF - functional independence measure and blood gas parameters.

Conditions

• Cardiac Surgical Procedures
• Continuous Positive Airway Pressure
• BIPAP Biphasic Intermittent Positive Airway Pressure

Interventions

PROCEDURE

CPAP

Use of non-invasive ventilation in patients in group 2 with CPAP.

PROCEDURE

BIPAP

Use of non-invasive ventilation in patients in group 3 with BIPAP.

PROCEDURE

Usual care in phisicaltherapy

Patients undergoing usual physiotherapy treatment, consisting of a kinesiotherapy protocol

Sponsors & Collaborators

• Universidade Estadual da Paraiba

  collaborator OTHER

• Universidade Federal do Rio Grande do Norte

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-08-31

Primary Completion

2024-02-29

Completion

2024-02-29

Countries

• Brazil

Study Locations