Mucociliary Clearance DefectClearanceMVNCT02604082
Comparison of Three Technical Airway Clearance in Mechanical Ventilated Patients
A study testing Vibrocompression (VB), Hyperinflation (HMV) and HMV+VB in people with Mucociliary Clearance Defect and Physical Disability, run by Hospital de Clinicas de Porto Alegre.
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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mucociliary Clearance Defect, Physical Disability
- What is being tested?
- Vibrocompression (VB), Hyperinflation (HMV) and HMV+VB
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- No sites listed yet
- Study dates
- Sep 2011to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Randomized clinical trial, conducted in the Intensive Care Unit of the Hospital de Clinicas de Porto Alegre from october 2011 until november 2015 .
Read the 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.
- Conditions
- Mucociliary Clearance Defect, Physical Disability
- Being tested
- Vibrocompression (VB), Hyperinflation (HMV), HMV+VB
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibrocompression (VB)Other
Also called Techinique of physical therapy
Vibrocompression is a physical therapy technique, that aims to clear the airways of patients on mechanical ventilation (MV)
Hyperinflation (HMV)Other
Also called Techinique of physical therapy
Hyperinflation technique with mechanical ventilator which aims to clear the airways of patients on mechanical ventilation
HMV+VBOther
Also called Techinique of physical therapy
Association between Vibrocompression and Hyperinflation with mechanical ventilator
| Study group | Role | What they receive |
|---|---|---|
| Vibocompression (VB) | Active comparator | 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 Receives: Other: Vibrocompression (VB) |
| Hyperinflation (HMV) | Active comparator | 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 . Receives: Other: Hyperinflation (HMV) |
| HMV+VB | Experimental | 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. Receives: Other: HMV+VB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight in grams of the pulmonary secretions
Measured: up to 24 weeks.
Secondary outcomes (9)
Time mechanical ventilator (MV) in days
Measured: Through study completion, an average of 3 years.
Reintubation tracheal in percentage in the last 24 hours
Measured: Through study completion, an average of 3 years.
Incidence of ventilator-associated pneumonia in percentage
Measured: Through study completion, an average of 3 years.
Mortality in the MV in percentage
Measured: Through study completion, an average of 3 years.
Heart Rate
Measured: up to 24 weeks.
Respiratory frequency
Measured: up to 24 weeks
Peripheral oxygen saturation in percentage
Measured: up to 24 weeks
Tidal volume in milliliters
Measured: up to 24 weeks
Peak inspiratory pressure in centimeters of water
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2015 (estimated)
- Study startSep 2011
- Primary completionAug 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mucociliary Clearance DefectStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Silvia R Rios Vieira, Dr, Principal investigator, HCPorto Alegre, Rio Grande do Sul - Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02604082
- Sponsor's protocol ID
- 11-0367
- Acronym
- ClearanceMV
- Status last verified
- Nov 2015
- First submitted
- 6 Nov 2015
- Last updated
- 13 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 24626270
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Three Technical Airway Clearance in Mechanical Ventilated Patients
- ClinicalTrials.gov ID
- NCT02604082
- Acronym / sponsor ID
- ClearanceMV / 11-0367
- Conditions
- Mucociliary Clearance Defect, Physical Disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Aug 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 13 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized clinical trial, conducted in the Intensive Care Unit of the Hospital de Clinicas de Porto Alegre from october 2011 until november 2015 .
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vibocompression (VB) | Active comparator | Other: Vibrocompression (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 |
| Hyperinflation (HMV) | Active comparator | Other: 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 . |
| HMV+VB | Experimental | Other: HMV+VBGrup 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- Pneumothorax and hemothorax undrained
- Subcutaneous emphysema
- Osteoporosis
- Acute respiratory distress syndrome - (ARDS)
- Fractures of ribs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vibrocompression (VB)Also: Techinique of physical therapyVibrocompression is a physical therapy technique, that aims to clear the airways of patients on mechanical ventilation (MV) | Other | Vibocompression (VB) |
| Hyperinflation (HMV)Also: Techinique of physical therapyHyperinflation technique with mechanical ventilator which aims to clear the airways of patients on mechanical ventilation | Other | Hyperinflation (HMV) |
| HMV+VBAlso: Techinique of physical therapyAssociation between Vibrocompression and Hyperinflation with mechanical ventilator | Other | HMV+VB |
Primary outcome
Weight in grams of the pulmonary secretions
Time frame: up to 24 weeks.
9 secondary outcomes
Time mechanical ventilator (MV) in days
Time frame: 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.
Incidence of ventilator-associated pneumonia in percentage
Time frame: Through study completion, an average of 3 years.
Mortality in the MV in percentage
Time frame: Through study completion, an average of 3 years.
Heart Rate
Time frame: up to 24 weeks.
Respiratory frequency
Time frame: up to 24 weeks
Peripheral oxygen saturation in percentage
Time frame: up to 24 weeks
Tidal volume in milliliters
Time frame: up to 24 weeks
Peak inspiratory pressure in centimeters of water
Time frame: up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2015.
- Results publication: PubMed 24626270Naue 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvia R Rios Vieira, Dr principal investigator
HCPorto Alegre, Rio Grande do Sul - Brazil
Questions about this trial
What is this clinical trial studying?
A study testing Vibrocompression (VB), Hyperinflation (HMV) and HMV+VB in people with Mucociliary Clearance Defect and Physical Disability, run by Hospital de Clinicas de Porto Alegre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight in grams of the pulmonary secretions (time frame: up to 24 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02604082, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2015.