The Effects of Mechanical Insufflation-exsufflation on Airway Mucus Clearance in the ICU

Hospital Moinhos de Vento170 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

170

Conditions

Respiratory Failure

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 Respiratory PhysiotherapyOTHER

Standard chest physiotherapy will be conducted through bilateral thoracic maneuvers (percussion and vibration) followed by manual hyperinflation using a manual resuscitator bag.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, Brazil

RECRUITING

Outcomes

Primary Outcomes

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).

Time frame: This outcome will be verified 5 minutes after the completion of the study intervention on the day of subject enrollment.

Secondary Outcomes

Static lung compliance

Single measure of the static lung compliance in mL/cm H2O

Time frame: This outcome will be verified 5 minutes after the completion of the study intervention on the day of subject enrollment.

Airway resistance

Single measure of the airway resistance in cm H2O/L/s

Time frame: This outcome will be verified 5 minutes after the completion of the study intervention on the day of subject enrollment.

Central Contacts

Marcio Camillis

CONTACT

55-51-996569173 marciocamillis@yahoo.com.br

Cassiano Teixeira, MD

CONTACT

55-51-3314-3782 cassiano.rush@gmail.com

Data from ClinicalTrials.gov

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