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

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

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 Overview

• Status: Unknown
• Conditions: Respiratory Failure
• Intervention / Treatment: Other: Mechanical insufflation-exsufflation; Other: Standard Respiratory Physiotherapy

• Study Type: Interventional
• Enrollment (Anticipated): 170
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90035001
      • Recruiting
      • Hospital Moinhos de Vento
      • Contact: Cassiano Teixeira, MD; Phone Number: 555133143387; Email: cassiano.rush@gmail.com
      • Principal Investigator: Marcio Camillis
      • Sub-Investigator: Cassiano Teixeira, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention Group; Respiratory physiotherapy using a mechanical insufflation-exsufflation device (CoughAssist)	Other: Mechanical insufflation-exsufflation; 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).; Other Names: CoughAssist
ACTIVE_COMPARATOR: Control Group; Respiratory physiotherapy according standard of care - without the use of a mechanical insufflation-exsufflation device.	Other: Standard Respiratory Physiotherapy; Standard chest physiotherapy will be conducted through bilateral thoracic maneuvers (percussion and vibration) followed by manual hyperinflation using a manual resuscitator bag.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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	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.

Collaborators and Investigators

• Sponsor: Hospital Moinhos de Vento
• Investigators: Principal Investigator: Marcio Camillis, Hospital Moinhos de Vento

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2016
• Primary Completion (ANTICIPATED): November 1, 2017
• Study Completion (ANTICIPATED): November 1, 2017

Study Registration Dates

• First Submitted: April 21, 2017
• First Submitted That Met QC Criteria: June 3, 2017
• First Posted (ACTUAL): June 7, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 7, 2017
• Last Update Submitted That Met QC Criteria: June 3, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Mechanical Ventilation; Respiratory Failure; Mechanical insufflation-exsufflation; Airway mucus clearance
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: CoughAssist trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO