Pulmonary atelectasis
Conditions
Interventions
This is a randomized, controlled clinical trial with six arms, with outcome assessor masking, in which outcome assessors were blinded to group allocation while patients and physiotherapists were not b
conventional full-face mask with noninvasive ventilation group, 28 patients
Wolf Mask full-face interface with noninvasive ventilation group, 29 patients
Elmo helmet with continuous positive airway pressure group, 30 patients
high-flow nasal cannula therapy group, 26 patients
and control group with conventional physiotherapy without active ventilatory support, 29 patients. Randomization was performed using sequentially numbered opaque envelopes generated from a random numb
Sponsors
Universidade Federal do Ceará - UFC
Universidade Federal do Ceará - UFC
Eligibility
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Age 18 to 80 years; postoperative status following elective coronary artery bypass grafting and/or valve surgery; hemodynamic stability with or without vasopressors in weaning; signed informed consent; participants of both sexes.
Exclusion criteria
Exclusion criteria: Emergency surgery; aortic surgery; geometric ventricular reconstruction; congenital heart disease correction; cardiac or pulmonary transplantation; reoperation; ejection fraction 25% or less; mean pulmonary artery pressure 35 mmHg or greater; BMI below 20 or above 40 kg/m2; chronic kidney disease requiring hemodialysis; COPD; hemodynamic instability (MAP below 60 mmHg); norepinephrine requirement above 7 mcg/kg/min; acute arrhythmia with hemodynamic compromise; significant bleeding with hemodynamic instability; bronchopleural fistula or pneumothorax with bubbling drains; enrollment in another study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate patient comfort with the ventilatory interface used, postoperative pulmonary complications, and the progression of early mobilization level throughout the intensive care unit stay. Comfort was assessed using a visual analog scale ranging from zero to ten, applied at the end of each physiotherapy session. Postoperative pulmonary complications were assessed using a clinical and radiological severity score, classified into grades one through five. Mobilization progression was assessed using a linear mixed-effects statistical model, with repeated evaluation across consecutive physiotherapy sessions. Statistically significant differences between groups are expected in comfort scores, in the distribution of pulmonary complications, and in the rate of mobilization progression, with better outcomes in the full-face interface groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the inspiratory pressure support required to achieve the target tidal volume, hemodynamic and ventilatory parameters during sessions, arterial blood gas values, peripheral muscle strength at intensive care unit discharge, and functional mobilization level at intensive care unit discharge. Pressure support was assessed using the parameters recorded on the mechanical ventilator, adjusted to achieve a tidal volume of six milliliters per kilogram of ideal body weight. Hemodynamic and ventilatory parameters were assessed using a digital multiparameter monitor, with recordings at four time points per session. Arterial blood gas values were assessed through blood sampling at up to four time points during the intensive care unit stay. Muscle strength was assessed using the Medical Research Council scale, with scores ranging from zero to sixty. Functional mobilization level was assessed using an ordinal mobility scale, applied at intensive care unit discharge. Lower pressure support requirements, better arterial blood gas values, higher muscle strength scores, and a higher proportion of patients reaching advanced mobilization levels are expected in the full-face interface groups compared with the control group. | — |
Countries
BR
Contacts
Public ContactBruno Okubo
Universidade Federal do Ceará
Outcome results
None listed