Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The long stay in mechanical ventilation can induce several complications, among them respiratory muscle weakness, this has been related to the duration of mechanical ventilation, delay and failure to wean, resulting in longer hospitalization, which reflects in greater care increase in hospital costs. Therefore, of this research will be to compare the effectiveness of early inspiratory muscle training (IMT) versus non-IMT in patients undergoing mechanical ventilation to improve the outcome of mechanical ventilation weaning time.
The study will consist of a randomized controlled clinical trial conducted at the Intensive Care Unit of the University Hospital of UNIVASF. Will be included individuals of both sexes, aged 18 years or older, who are on invasive mechanical ventilation and who obtain the Free and Informed Consent Form, signed by the responsible family member. Subjects will be randomized into two groups (training and control). The inspiratory (MIP), expiratory (MEP) and peak expiratory flow pressures will be evaluated. The training group will perform respiratory muscle training, using the Powerbreath equipment, with initial loading of 40% of MIP, 7 days a week, 2 times a day. Morbidities that have repercussions on diaphragmatic contraction and end-stage disease will be used as exclusion criteria. The sample data will be analyzed through the SPSS 22.0 program. The significance level of the study will be set at 5% (p <0.05).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inspiratory Muscle Training (IMT) | Experimental | IMT by means of the Powerbreath equipment (Classic, London, UK), according to the following parameters: initial loading of 40% of MIP, 3 sets of 10 repetitions with interval of 1 minute between each sets, 7 days a week, 2 times a day , with the patients in the bed with the angulation of 45 °. The IMT load settings will be adjusted according to the values evaluated weekly. If there is need for addition of supplemental oxygen will be performed to perform the IMT. |
|
| Intensive Physiotherapy (IPT) | Active Comparator | IPT will be to individualized and supervised intervention program consisting of any of the following procedures: passive, assisted, active or resisted mobilization, sedation and orthostasis depending on the functional level of the patient, as well as bronchial hygiene therapy and pulmonary expansion therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inspiratory Muscle Training (IMT) | Other | Inspiratory Muscle Training (IMT) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weaning mechanical ventilation | time of mechanical ventilation | through study completion, an average of 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| length of stay in the ICU | reduction length of stay in the ICU | through study completion, an average of 15 days |
| extubation success | extubation success after 48 hours |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rodrigo GS Carvalho, PhD | Contact | +5587999832015 | rodrigocarvalhofisio@gmail.com | |
| Rodrigo GS Carvalho, PhD | Contact | +558721016856 | rodrigo.carvalho@univasf.edu.br |
| Name | Affiliation | Role |
|---|---|---|
| Rodrigo GS Carvalho, PhD | Physical Education College / UNIVASF | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Physical Education College | Recruiting | Petrolina | Pernambuco | 56304917 | Brazil |
Registration ClinicalTrials; Study Protocol; Paper results.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
Compare the effectiveness of early inspiratory muscle training (IMT) versus non-IMT in patients undergoing mechanical ventilation to improve the outcome of mechanical ventilation weaning time.
Not provided
Not provided
Not provided
| Intensive Physiotherapy (IPT) | Other | Intensive Physiotherapy (IPT) |
|
| through study completion, an average of 2 days |
| death | reduction in mortality (death) | yes or not death, through study completion, an average of 15 days |