Clinical trial NCT06611527: Positive Pressure Therapy to Optimize LUNG Function After Heart Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Period
Physical Therapy Modalities
Continuous Positive Airway Pressure
Respiratory Function Tests
Pulmonary Atelectasis
Heart Surgery
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: InCor Heart Institute
First posted: 2024-09-25
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Severity of pulmonary complications in the postoperative period
timeFrame: Participants will be followed for 7 days after surgery.
measure: Electrical impedance tomography (EIT) ventilation distribution
timeFrame: EIT ventilation distribution will be monitored during and 30 minutes after the therapies.
Secondary outcomes:
measure: Length of ICU stay
timeFrame: From the day of surgery up to ICU discharge, an expected average of 2 days, and maximum censoring at day 28 after surgery.
measure: Length of hospital stay
timeFrame: From the day of surgery up to hospital discharge, an expected average of 10 days, and maximum censoring at day 28 after surgery.
measure: Handgrip strength
timeFrame: Assessments will be conducted preoperatively, on the 5th and 7th postoperative days.
measure: Maximal inspiratory and expiratory pressures
timeFrame: Assessments will be conducted preoperatively, on the 5th and 7th postoperative days.
measure: Spirometry test results
timeFrame: Spirometry will be conducted preoperatively, on the 5th and 7th postoperative days.
measure: Positive pressure therapy comfort level
timeFrame: The level of comfort will be evaluated immediately after the first three positive pressure therapy sessions.
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Instituto do Coração - HCFMUSP
state: SP
Study officials:
affiliation: Federal University of São Paulo
name: Marcia S Volpe, PhD
role: PRINCIPAL_INVESTIGATOR
References: