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

November 11, 2015 updated by: Hospital de Clinicas de Porto Alegre
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
93

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Weight in grams of the pulmonary secretions
Time Frame: up to 24 weeks.
up to 24 weeks.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Time mechanical ventilator (MV) in days
Time Frame: Through study completion, an average of 3 years.
Through study completion, an average of 3 years.
Reintubation tracheal in percentage in the last 24 hours
Time Frame: Through study completion, an average of 3 years.
Through study completion, an average of 3 years.
Incidence of ventilator-associated pneumonia in percentage
Time Frame: Through study completion, an average of 3 years.
Through study completion, an average of 3 years.
Mortality in the MV in percentage
Time Frame: Through study completion, an average of 3 years.
Through study completion, an average of 3 years.
Heart Rate
Time Frame: up to 24 weeks.
up to 24 weeks.
Respiratory frequency
Time Frame: up to 24 weeks
up to 24 weeks
Peripheral oxygen saturation in percentage
Time Frame: up to 24 weeks
up to 24 weeks
Tidal volume in milliliters
Time Frame: up to 24 weeks
up to 24 weeks
Peak inspiratory pressure in centimeters of water
Time Frame: up to 24 weeks
up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital de Clinicas de Porto Alegre

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Silvia R Rios Vieira, Dr, HCPorto Alegre, Rio Grande do Sul - Brazil

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 6, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 11-0367

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