Infant Cardiovascular Diseases
Conditions
Interventions
This is a planned, controlled, two-arm clinical trial with blinding only to the participant, to evaluate the acute effect of a single physiotherapy intervention. Twenty participants will be randomly a
and 10 infants in the Comparator Group, named Assisted Autogenic Drainage, which involves the application of gentle bimanual pressure to the chest wall to target different lung volumes (small, medium,
Sponsors
Faculdade de Ciências da Saúde do Trairí
Faculdade de Ciências da Saúde do Trairí
Eligibility
Age
No minimum to 2 Years
Inclusion criteria
Inclusion criteria: Participants aged between 0 and 24 months; of both sexes; between 12 and 72 hours after cardiac surgical procedures performed via median sternotomy or percutaneous route (catheterization); Infants must present clinical stability that allows respiratory physiotherapy; whether in room air or using oxygen therapy (low or high flow)
Exclusion criteria
Exclusion criteria: Infants with chronic lung disease that compromises respiratory function such as bronchopulmonary dysplasia; those using positive pressure ventilation; those with congenital deformities of the rib cage or shoulder girdle; those who develop diaphragmatic paralysis postoperativel; present hemodynamic instability defined as persistent changes in heart rate or blood pressure outside the limits for age and arrhythmias of difficult control
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| t’s expected to observe pain assessed through the face legs activity cry consolability scale and the autonomic system parameters measured through heart rate and peripheral oxygen saturation and respiratory rate and peripheral blood pressure obtained by a multiparameter monitor at three moments being before the intervention and immediately after the intervention and thirty minutes after the intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| It’s expected to observe secondary outcomes including physiological and clinical and viability parameters related to the interventions such as diaphragmatic excursion assessed by m mode ultrasonography obtaining the amplitude of diaphragmatic displacement during spontaneous breathing considering the average of three consecutive measurements with a variation of less than ten percent between them and the slope variable corresponding to the speed of diaphragmatic displacement during the inspiratory phase expressed in millimeters per second and obtained automatically by the equipment software and respiratory distress measured by the silverman andersen score being a clinical instrument validated for the assessment of respiratory effort in neonates and infants and the amount of pulmonary secretion removed measured by non invasive aspiration using a specific device connected to a standardized suction system being the collected secretion quantified through the weight difference of the collector before and after the procedure with the result expressed in grams;It’s expected to observe the study viability outcomes including the recruitment rate defined as the proportion of eligible patients who will be included and randomized in the study over the collection period expressed as a monthly average and the occurrence of adverse events related or not to the interventions monitored during and up to thirty minutes after the application of the techniques including frequency and type and severity and the adherence to the evaluation protocol measured by the time required to fully complete the evaluations at the established moments of baseline and immediate post intervention and thirty minute follow up expressed in minutes | — |
Countries
BR
Contacts
Public ContactBeatriz Ferreira
Faculdade de Ciências da Saúde do Trairí
Outcome results
None listed