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

Primary Purpose

Respiratory Failure

Status

Unknown status

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Mechanical insufflation-exsufflation

Standard Respiratory Physiotherapy

About this trial

This is an interventional supportive care trial for Respiratory Failure focused on measuring Respiratory Failure, Mechanical Ventilation, Mechanical insufflation-exsufflation, Airway mucus clearance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hospital Moinhos de VentoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention Group

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Static lung compliance

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

Airway resistance

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

Full Information

NCT ID

NCT03178565

First Posted

April 21, 2017

Last Updated

June 3, 2017

Sponsor

Hospital Moinhos de Vento

1. Study Identification

Unique Protocol Identification Number

NCT03178565

Brief Title

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

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Unknown status

Study Start Date

December 2016 (Actual)

Primary Completion Date

November 2017 (Anticipated)

Study Completion Date

November 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital Moinhos de Vento

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Respiratory Failure

Keywords

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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).

Masking

None (Open Label)

Allocation

Randomized

Enrollment

170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention Group

Arm Type

Experimental

Arm Description

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

Arm Title

Control Group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Mechanical insufflation-exsufflation

Other Intervention Name(s)

CoughAssist

Intervention Description

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).

Intervention Type

Other

Intervention Name(s)

Standard Respiratory Physiotherapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Amount of aspirated secretion

Description

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 Outcome Measure Information:

Title

Static lung compliance

Description

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.

Title

Airway resistance

Description

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marcio Camillis

Phone

55-51-996569173

marciocamillis@yahoo.com.br

First Name & Middle Initial & Last Name or Official Title & Degree

Cassiano Teixeira, MD

Phone

55-51-3314-3782

cassiano.rush@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marcio Camillis

Organizational Affiliation

Hospital Moinhos de Vento

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Moinhos de Vento

City

Porto Alegre

State/Province

Rio Grande do Sul

ZIP/Postal Code

90035001

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Cassiano Teixeira, MD

Phone

555133143387

cassiano.rush@gmail.com

First Name & Middle Initial & Last Name & Degree

Marcio Camillis

First Name & Middle Initial & Last Name & Degree

Cassiano Teixeira, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30018175

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.

Results Reference

derived

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

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