Clinical trial NCT03178565: The Effects of Mechanical Insufflation-exsufflation on Airway Mucus Clearance in the ICU
Official title: The Effects of Mechanical Insufflation-exsufflation for Airway Mucus Clearance Among Mechanically Ventilated ICU Patients: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Respiratory Failure
Keywords: Respiratory Failure
Mechanical Ventilation
Mechanical insufflation-exsufflation
Airway mucus clearance
Lead sponsor: Hospital Moinhos de Vento
Sponsor class: OTHER
First posted: 2017-06-07
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Amount of aspirated secretion
timeFrame: This outcome will be verified 5 minutes after the completion of the study intervention on the day of subject enrollment.
Secondary outcomes:
measure: Static lung compliance
timeFrame: This outcome will be verified 5 minutes after the completion of the study intervention on the day of subject enrollment.
measure: Airway resistance
timeFrame: This outcome will be verified 5 minutes after the completion of the study intervention on the day of subject enrollment.
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital Moinhos de Vento
state: Rio Grande do Sul
Study officials:
affiliation: Hospital Moinhos de Vento
name: Marcio Camillis
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.