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

NCT03178565 | Unknown

• 1 other identifier: CoughAssist trial
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Failure

Keywords

Respiratory Failure; Mechanical Ventilation; Mechanical insufflation-exsufflation; Airway mucus clearance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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 Arms (2)

Intervention Group

EXPERIMENTAL

Respiratory physiotherapy using a mechanical insufflation-exsufflation device (CoughAssist)

Other: Mechanical insufflation-exsufflation

Control Group

ACTIVE COMPARATOR

Respiratory physiotherapy according standard of care - without the use of a mechanical insufflation-exsufflation device.

Other: Standard Respiratory Physiotherapy

Interventions

Mechanical insufflation-exsufflation OTHER

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).

Also known as: CoughAssist

Intervention Group

Standard Respiratory Physiotherapy OTHER

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

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with primary neuromuscular disease.
• Patients in exclusive paliative care.
• Patients with contraindications to the use of mechanical insufflation- Exsufflation device.

Sponsors & Collaborators

• Hospital Moinhos de Vento: lead

Study Sites (1)

Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, 90035001, Brazil

RECRUITING

Related Publications (1)

• 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.

  PMID: 30018175 DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Marcio Camillis

  Hospital Moinhos de Vento

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcio Camillis

CONTACT

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

Cassiano Teixeira, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: 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).

Study Record Dates

• First Submitted: April 21, 2017
• First Posted: June 7, 2017
• Study Start: December 1, 2016
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: June 7, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)