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Clinical Trials/NCT03178565
NCT03178565
Unknown
Not Applicable

The Effects of Mechanical Insufflation-exsufflation for Airway Mucus Clearance Among Mechanically Ventilated ICU Patients: a Randomized Trial

Hospital Moinhos de Vento1 site in 1 country170 target enrollmentDecember 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Respiratory Failure
Sponsor
Hospital Moinhos de Vento
Enrollment
170
Locations
1
Primary Endpoint
Amount of aspirated secretion
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2016
End Date
November 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Augusto Savi

PhD

Hospital Moinhos de Vento

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.

Outcomes

Primary Outcomes

Amount of aspirated secretion

Time Frame: 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 Outcomes

  • Static lung compliance(This outcome will be verified 5 minutes after the completion of the study intervention on the day of subject enrollment.)
  • Airway resistance(This outcome will be verified 5 minutes after the completion of the study intervention on the day of subject enrollment.)

Study Sites (1)

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