Positive Pressure Therapy to Optimize LUNG Function After Heart Surgery

Официальное название

Comparison Between Two Methods of Positive Pressure Therapy in the Prevention of Pulmonary Complications in the Immediate Postoperative Period of Cardiac Surgery: a Prospective, Randomized Clinical Trial

Обзор

The most common cardiac surgeries are myocardial revascularization and valve replacement or plastic surgery. In the postoperative period of cardiac surgeries, the incidence of pulmonary complications ranges from 30% to 50% and is associated with increased length of hospital stay and morbidity and mortality. To reduce or minimize the occurrence of these complications, respiratory physiotherapy employs positive pressure reexpansion therapies, such as continuous positive airway pressure (CPAP) and positive pressure support with positive end-expiratory pressure (PS+PEEP). The goal of this clinical trial is to compare the effects of two positive pressure therapies, CPAP versus PS+PEEP, on the incidence of pulmonary complications in patients in the postoperative period of myocardial revascularization and valve replacement or plastic surgery, with mild to moderate pulmonary dysfunction. The main question it aims to answer is: Do patients in the immediate postoperative period of myocardial revascularization or valve replacement/plastic surgery, exhibiting mild to moderate pulmonary dysfunction, experience a comparable reversal of pulmonary conditions when treated with PS+PEEP versus CPAP? Participants will undergo the following assessments: spirometry, respiratory muscle strength testing, handgrip strength testing, and electrical impedance tomography. In the immediate postoperative period, participants will be randomized into two treatment groups: • Control Group PS+PEEP - application of 4 sets of 20 repetitions with PS to provide a tidal volume equal to 10ml/kg of predicted body weight, PEEP equal to 10 cmH2O, and inspired oxygen fraction (FiO2) to achieve peripheral oxygen saturation (SpO2) between 92-94%; • Experimental Group CPAP - application of CPAP at 10 cmH2O with FiO2 to achieve SpO2 between 92-94% for 30 minutes.

Вмешательства

• Устройство PS+PEEP group
  Application of 4 sets of 20 repetitions with PS to provide a tidal volume equal to 10ml/kg of predicted body weight, PEEP equal to 10 cmH2O, and inspired oxygen fraction (FiO2) to achieve peripheral oxygen saturation (SpO2) between 92-94%
• Устройство CPAP group
  Application of CPAP of 10 cmH2O with FiO2 to achieve SpO2 between 92-94% for 30 minutes.

Первичные конечные точки

• Severity of pulmonary complications in the postoperative period [Срок оценки: Participants will be followed for 7 days after surgery.]
• Electrical impedance tomography (EIT) ventilation distribution [Срок оценки: EIT ventilation distribution will be monitored during and 30 minutes after the therapies.]

Вторичные конечные точки (6)

• Length of ICU stay [Срок оценки: From the day of surgery up to ICU discharge, an expected average of 2 days, and maximum censoring at day 28 after surgery.]
• Length of hospital stay [Срок оценки: From the day of surgery up to hospital discharge, an expected average of 10 days, and maximum censoring at day 28 after surgery.]
• Handgrip strength [Срок оценки: Assessments will be conducted preoperatively, on the 5th and 7th postoperative days.]
• Maximal inspiratory and expiratory pressures [Срок оценки: Assessments will be conducted preoperatively, on the 5th and 7th postoperative days.]
• Spirometry test results [Срок оценки: Spirometry will be conducted preoperatively, on the 5th and 7th postoperative days.]
• Positive pressure therapy comfort level [Срок оценки: The level of comfort will be evaluated immediately after the first three positive pressure therapy sessions.]

Критерии участия

Критерии включения

• Immediate postoperative period of myocardial revascularization and/or valve replacement or plastic surgery;
• Patients in the preoperative period at risk of developing pulmonary complications, characterized by the presence of at least 2 of the following risk factors: age ≥ 70 years, productive cough, diabetes, history of smoking, chronic obstructive pulmonary disease (COPD) defined by forced expiratory volume in 1 second (FEV1) lower than 75% of predicted, body mass index (BMI) ≥ 27 kg/m2, or only FEV1 lower than 80% and FEV1/forced vital capacity (FVC) ratio lower than 70% of predicted; OR patients in the postoperative period (up to 12 hours after extubation) with mild to moderate complications characterized by a pulmonary complication score lower than 3.

Критерии исключения

• Hemodynamic instability characterized by mean arterial pressure (MAP) lower than 60mmHg and/or acute arrhythmia of any etiology;
• Need for intra-aortic balloon;
• Duration of invasive mechanical ventilation exceeding 24 hours after surgery;
• Pulmonary complication score ≥ grade 3;
• Presence of signs of acute respiratory failure, such as respiratory rate (f) ≥ 25 breaths/min and use of accessory muscles;
• Chest tube with air leak;
• Use of a pacemaker or implantable or external cardioverter-defibrillator.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Бразилия · 1 центр

• Instituto do Coração - HCFMUSP — São Paulo

Идентификаторы

NCT: NCT06611527 · RPPI

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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