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The present study aims to evaluate the effect of mechanical insufflation-exsufflation on airway mucus clearance among mechanically ventilated ICU patients. A parallel group randomized clinical trial will be conducted in a single mixed medical-surgical ICU of a tertiary hospital in Southern Brazil. Adult ICU patients with a length of mechanical ventilation >24 hours will be evaluated for eligibility. Patients will be randomized in a 1:1 ratio to receive respiratory physiotherapy using a mechanical insufflation-exsufflation device (intervention group) or standard respiratory physiotherapy without the use of the mechanical insufflation-exsufflation device (control group). The primary outcome is the amount of aspirated respiratory mucus (weight in grams) 5 minutes after the finish of respiratory physiotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Respiratory physiotherapy using a mechanical insufflation-exsufflation device (CoughAssist) |
|
| Control Group | Active Comparator | Respiratory physiotherapy according standard of care - without the use of a mechanical insufflation-exsufflation device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mechanical insufflation-exsufflation | Other | The mechanical insufflation-exsufflation device will be connected in the orotracheal tube. Four series of insufflation-exsufflation will be conducted. Each serie will be composed by 10 cycles of alternated insufflation (40 cmH2O) and exsufflation (- 40 cmH2O). |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of aspirated secretion | Single measure of weight in grams of the aspirated secretion 5 minutes after the study intervention (mechanical insufflation-exsufflation or standard respiratory physiotherapy). | This outcome will be verified 5 minutes after the completion of the study intervention on the day of subject enrollment. |
| Measure | Description | Time Frame |
|---|---|---|
| Static lung compliance | Single measure of the static lung compliance in mL/cm H2O | This outcome will be verified 5 minutes after the completion of the study intervention on the day of subject enrollment. |
| Airway resistance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marcio Camillis | Contact | 55-51-996569173 | marciocamillis@yahoo.com.br | |
| Cassiano Teixeira, MD | Contact | 55-51-3314-3782 | cassiano.rush@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Marcio Camillis | Hospital Moinhos de Vento | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Moinhos de Vento | Recruiting | Porto Alegre | Rio Grande do Sul | 90035001 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30018175 | Derived | Ferreira de Camillis ML, Savi A, Goulart Rosa R, Figueiredo M, Wickert R, Borges LGA, Galant L, Teixeira C. Effects of Mechanical Insufflation-Exsufflation on Airway Mucus Clearance Among Mechanically Ventilated ICU Subjects. Respir Care. 2018 Dec;63(12):1471-1477. doi: 10.4187/respcare.06253. Epub 2018 Jul 17. |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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Mechanically ventilated patients will be randomized to receive respiratory physiotherapy using a mechanical insufflation-exsufflation device (intervention group) or to receive standard respiratory physiotherapy without the use of a mechanical insufflation-exsufflation device (control group).
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|
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| Standard Respiratory Physiotherapy | Other | Standard chest physiotherapy will be conducted through bilateral thoracic maneuvers (percussion and vibration) followed by manual hyperinflation using a manual resuscitator bag. |
|
Single measure of the airway resistance in cm H2O/L/s
| This outcome will be verified 5 minutes after the completion of the study intervention on the day of subject enrollment. |