Comparison of Three Technical Airway Clearance in Mechanical Ventilated Patients (ClearanceMV)

Randomized clinical trial, conducted in the Intensive Care Unit of the Hospital de Clinicas de Porto Alegre from october 2011 until november 2015 .

Study Overview

• Status: Completed
• Conditions: Physical Disability; Mucociliary Clearance Defect
• Intervention / Treatment: Other: Vibrocompression (VB); Other: Hyperinflation (HMV); Other: HMV+VB

Detailed Description

Objective: To compare the effectiveness of techniques: vibrocompression (G1), hyperinflation with mechanical ventilation (G2) vibrocompression + hyperinflation with mechanical ventilation (G3) in the amount of aspirated secretions, mechanical ventilator time, incidence of ventilator-associated pneumonia , reintubation tracheal and mortality in mechanical ventilator. Primary outcome: weight in grams of the aspirated secretions. Secondary outcome: hemodynamic and pulmonary parameters: heart rate, respiratory rate, mean arterial pressure, peripheral arterial oxygen saturation; peak inspiratory pressure, tidal volume; dynamic compliance ; mechanical ventilator time; reintubation tracheal; Incidence of ventilator-associated pneumonia and mortality in mechanical ventilator.

• Study Type: Interventional
• Enrollment (Actual): 93
• Phase: Not Applicable

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:

• In mechanical ventilation for a period of 24-72 h
• End-expiratory pressure (PEEP) lower 10 cm of water.
• Lower noradrenaline doses of 0.5mg / kg / minute for an average greater than or equal blood outstrips 60 mmHg.

Exclusion Criteria:

• Pneumothorax and hemothorax undrained
• Subcutaneous emphysema
• Osteoporosis
• Acute respiratory distress syndrome - (ARDS)
• Fractures of ribs
• Obese ( BMI greater than 35)
• Mechanical ventilator with higher peak pressures 40 cm of water.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Vibocompression (VB); Grup 1 - Vibrocompression: Is a physical therapy technique, that aims to clear the airways of patients on mechanical ventilation. Through the thoracic compression during expiration	Other: Vibrocompression (VB); Vibrocompression is a physical therapy technique, that aims to clear the airways of patients on mechanical ventilation (MV); Other Names: Techinique of physical therapy
Active Comparator: Hyperinflation (HMV); Grup 2 - Hyperinflation with Mechanical ventilator: Is a physical therapy technique, that aims to clear the airways of patients on mechanical ventilation. Through the increase in inspiratory pressure ventilator .	Other: Hyperinflation (HMV); Hyperinflation technique with mechanical ventilator which aims to clear the airways of patients on mechanical ventilation; Other Names: Techinique of physical therapy
Experimental: HMV+VB; Grup 3 - Hyperinflation with mechanical ventilator and vibrocompression:Is a physical therapy technique, that aims to clear the airways of patients on mechanical ventilation. Through the thoracic compression during expiration and the increase in inspiratory pressure ventilator.	Other: HMV+VB; Association between Vibrocompression and Hyperinflation with mechanical ventilator; Other Names: Techinique of physical therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Weight in grams of the pulmonary secretions	up to 24 weeks.

Secondary Outcome Measures

Outcome Measure	Time Frame
Time mechanical ventilator (MV) in days	Through study completion, an average of 3 years.
Reintubation tracheal in percentage in the last 24 hours	Through study completion, an average of 3 years.
Incidence of ventilator-associated pneumonia in percentage	Through study completion, an average of 3 years.
Mortality in the MV in percentage	Through study completion, an average of 3 years.
Heart Rate	up to 24 weeks.
Respiratory frequency	up to 24 weeks
Peripheral oxygen saturation in percentage	up to 24 weeks
Tidal volume in milliliters	up to 24 weeks
Peak inspiratory pressure in centimeters of water	up to 24 weeks

Collaborators and Investigators

• Sponsor: Hospital de Clinicas de Porto Alegre
• Investigators: Principal Investigator: Silvia R Rios Vieira, Dr, HCPorto Alegre, Rio Grande do Sul - Brazil

Publications and helpful links

General Publications

• Naue Wda S, Forgiarini Junior LA, Dias AS, Vieira SR. Chest compression with a higher level of pressure support ventilation: effects on secretion removal, hemodynamics, and respiratory mechanics in patients on mechanical ventilation. J Bras Pneumol. 2014 Jan-Feb;40(1):55-60. doi: 10.1590/S1806-37132014000100008.

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: November 6, 2015
• First Submitted That Met QC Criteria: November 11, 2015
• First Posted (Estimate): November 13, 2015

Study Record Updates

• Last Update Posted (Estimate): November 13, 2015
• Last Update Submitted That Met QC Criteria: November 11, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 11-0367