Respiratory Failure
Conditions
Keywords
Respiratory Failure, Mechanical Ventilation, Mechanical insufflation-exsufflation, Airway mucus clearance
Brief summary
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.
Interventions
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).
Standard chest physiotherapy will be conducted through bilateral thoracic maneuvers (percussion and vibration) followed by manual hyperinflation using a manual resuscitator bag.
Sponsors
Hospital Moinhos de Vento
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years; * Admission to the ICU * Length of mechanical ventilation \> 24 hours * Stable ventilatory and hemodynamic status defined by positive end- expiratory pressure ≤ 8 cm H2O, inspiratory oxygen fraction ≤ 40%, ratio of arterial oxygen partial pressure to fractional inspired oxygen ≥ 150, respiratory rate ≤ 35 breaths per minute, heart rate ≤ 130 beats per minute and systolic blood pressure between 90 and 160 mmHg.
Exclusion criteria
* Patients with primary neuromuscular disease. * Patients in exclusive paliative care. * Patients with contraindications to the use of mechanical insufflation- Exsufflation device.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amount of aspirated secretion | This outcome will be verified 5 minutes after the completion of the study intervention on the day of subject enrollment. | Single measure of weight in grams of the aspirated secretion 5 minutes after the study intervention (mechanical insufflation-exsufflation or standard respiratory physiotherapy). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Static lung compliance | This outcome will be verified 5 minutes after the completion of the study intervention on the day of subject enrollment. | Single measure of the static lung compliance in mL/cm H2O |
| Airway resistance | This outcome will be verified 5 minutes after the completion of the study intervention on the day of subject enrollment. | Single measure of the airway resistance in cm H2O/L/s |
Countries
Brazil
Contacts
Primary ContactMarcio Camillis
Backup ContactCassiano Teixeira, MD
Outcome results
None listed