Effects of Non-invasive Ventilation With Different Modalities in Patients Undergoing Heart Surgery: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Length of hospital stay
研究概览
简要总结
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.
详细描述
The study protocol was conducted following the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist. This is a single-center, randomized, controlled, double-blind clinical trial, in which participants and outcome evaluators were blinded. The study will be submitted to the ethics committee of the State University of Paraíba (UEPB) and carried out in accordance with the Declaration of Helsinki. All participants must provide written informed consent prior to participation, and the study will be registered on the CLINICALTRIALS platform. All participants must provide written informed consent prior to participation. Participants will be divided into three groups (cpap group - CPAP + usual physical therapy care, bipap group - BIPAP + usual physical therapy care and control group - usual physical therapy care), in a 1:1 allocation ratio and superiority.
The project will be carried out at Hospital João XXIII in the city of Campina Grande, Paraíba, Brazil. It is a private hospital affiliated with the SUS network, a reference in cardiology and especially in cardiac surgery for a good part of the state and surrounding states. It presents in its weekly program an average of 8 cardiac surgeries. The evaluation and intervention will take place in the ICU and ward.
Post-randomization exclusion criteria: In case of undertaking any treatment in the hospital environment that contraindicates participation in the study (pacemaker implantation, pneumothorax requiring chest drainage, for example), death or other decompensations not related to the research and return to the ICU .
Criteria for non-adherence to the intervention: Patient who does not perform 3 or more sessions in a row, who withdrew from participating in the study and who has some cardiac arrhythmia (atrial fibrillation, bradycardia) for two sessions even after medication used to contain and pause for rest.
Non-retention criteria: Patient who does not perform one of the reassessments. Professional eligibility criteria: Hospital staff physiotherapists and physiotherapy students with previous training in the research protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
This is a single-center, randomized, controlled, double-blind clinical trial, in which participants and outcome evaluators were blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing cardiac surgery
- •aged over 18 years
- •stable from the hemodynamic point of view (controlled blood pressure, normocardic
- •conscious and oriented and cooperative4
- •without medical restrictions for carrying out the treatment
排除标准
- •Presence of uncontrolled cardiac arrhythmias (Examples: total atrioventricular block, type 2 2nd degree atrioventricular block, atrial fibrillation, sustained ventricular tachycardia)
- •previous neuromuscular disease
- •labyrinthitis and some orthopedic/skeletal muscle restriction.
- •Unstable angina, stage 3 SAH (SBP ≥ 180 mmHg and/or DBP ≥ 110 mmHg at rest), HR > 120 bpm at rest, systemic arterial hypotension with clinical repercussions (SBP ≤ 90 mmHg and/or DBP ≤ 60 mmHg),(),
- •aortic dissection.
结局指标
主要结局
Length of hospital stay
时间窗: The length of hospital stay will be assessed and reported as the number of days from admission to discharge, measured up to 2 weeks after the date of randomization.
Absolute number of days of hospitalization up to 2 weeks after the date of randomization.
Pulmonary function
时间窗: Day 1 and day 5
All participants will undergo an evaluation by a CONTEC model spirometer (SPB80b, CHINA) to verify lung volumes and capacities. At least three tests will be performed, with a variation of less than 5% and the highest value obtained in one of the tests will be compared with the predicted values of pulmonary function parameters for the Brazilian population. FEV1 and FVC will be assessed. The predicted values will be calculated using the reference values (PEREIRA et al., 2007).
Presence of lung complications
时间窗: From the date of randomization to the date of the first documented progression or the date of death from any cause, whichever occurs first, measured up to 2 weeks after the date of hospital discharge.
assessment of the occurrence or absence of any complications related to the lungs during the hospitalization period.cause, whichever occurs first, measured up to 2 weeks
次要结局
- The global perception of change scale(Day 1 and Day 5)
- Score of the Minnesota Living with Heart Failure Questionnaire (MLHFQ) in Portuguese version(Day 1 and Day 5)
- Funcional capacity(Day 1 and Day 5)
- The functional independence measure (MIF)(Day 1 and Day 5)
- HCO3 (bicarbonate)(Days 1 and 2.)
- Base Excess (BE)(Days 1 and 2.)
- pO2 (partial pressure of oxygen)(Days 1 and 2.)
- pCO2 (partial pressure of carbon dioxide)(Days 1 and 2.)
- Arterial Oxygen Saturation (SaO2)(Days 1 and 2.)
研究者
Patri-cia Angelica de Miranda Silva Nogueira
Head professor of physiotherapy course and pós-graduate course.
Universidade Federal do Rio Grande do Norte