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

Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03178565
• Other study ID #: CoughAssist trial
• Status: Recruiting
• Phase: N/A
• First received: April 21, 2017
• Last updated: June 3, 2017
• Start date: December 2016
• Est. completion date: November 2017

Study information

• Verified date: June 2017
• Source: Hospital Moinhos de Vento
• Contact: Marcio Camillis
• Phone: 55-51-996569173
• Email: marciocamillis[@]yahoo.com.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Intervention

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).
• 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.

Locations

Country	Name	City	State
Brazil	Hospital Moinhos de Vento	Porto Alegre	Rio Grande do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Moinhos de Vento

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.