Comparison of Three Technical Airway Clearance in Mechanical Ventilated Patients

Physical Disability Clinical Trial

— ClearanceMV  

Official title:

Comparison of Three Technical Airway Clearance in Mechanical Ventilated Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02604082
• Other study ID #: 11-0367
• Status: Completed
• Phase: N/A
• First received: November 6, 2015
• Last updated: November 11, 2015
• Start date: September 2011
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: November 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mucociliary Clearance Defect
• Physical Disability

Intervention

Other:
• Vibrocompression (VB)
Vibrocompression is a physical therapy technique, that aims to clear the airways of patients on mechanical ventilation (MV)
• Hyperinflation (HMV)
Hyperinflation technique with mechanical ventilator which aims to clear the airways of patients on mechanical ventilation
• HMV+VB
Association between Vibrocompression and Hyperinflation with mechanical ventilator

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight in grams of the pulmonary secretions		up to 24 weeks.	Yes
Secondary	Time mechanical ventilator (MV) in days		Through study completion, an average of 3 years.	Yes
Secondary	Reintubation tracheal in percentage in the last 24 hours		Through study completion, an average of 3 years.	Yes
Secondary	Incidence of ventilator-associated pneumonia in percentage		Through study completion, an average of 3 years.	Yes
Secondary	Mortality in the MV in percentage		Through study completion, an average of 3 years.	Yes
Secondary	Heart Rate		up to 24 weeks.	Yes
Secondary	Respiratory frequency		up to 24 weeks	Yes
Secondary	Peripheral oxygen saturation in percentage		up to 24 weeks	Yes
Secondary	Tidal volume in milliliters		up to 24 weeks	Yes
Secondary	Peak inspiratory pressure in centimeters of water		up to 24 weeks	Yes