Instituto do Coração - HCFMUSP
São Paulo, 05403-900, Brazil
Location status: Recruiting
NCT Number: NCT06611527
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
São Paulo, 05403-900, Brazil
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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%
Application of CPAP of 10 cmH2O with FiO2 to achieve SpO2 between 92-94% for 30 minutes.
Time frame: Participants will be followed for 7 days after surgery.
Score of pulmonary complications adapted from previous publications, with 5 degrees, where the higher one (5) means death before hospital discharge, and degree 4 means need of invasive mechanical ventilation due to acute respiratory failure.
Time frame: EIT ventilation distribution will be monitored during and 30 minutes after the therapies.
Time frame: From the day of surgery up to ICU discharge, an expected average of 2 days, and maximum censoring at day 28 after surgery.
Time frame: From the day of surgery up to hospital discharge, an expected average of 10 days, and maximum censoring at day 28 after surgery.
Time frame: Assessments will be conducted preoperatively, on the 5th and 7th postoperative days.
Time frame: Assessments will be conducted preoperatively, on the 5th and 7th postoperative days.
Time frame: Spirometry will be conducted preoperatively, on the 5th and 7th postoperative days.
Forced expiratory volume in the first second (FEV1), forced vital capacity (FVC), and the FEV1/FVC ratio from the spirometry test will be presented as percentages of predicted values.
Time frame: The level of comfort will be evaluated immediately after the first three positive pressure therapy sessions.
Comfort during positive pressure therapy will be assessed using a visual analog scale ranging from 0 to 10, where 0 represents maximum comfort and 10 represents extreme discomfort.
Contact information is provided by the study sponsor or research team.
Federal University of São Paulo
Other
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
Acronym: PRO-LUNGHS
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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