Respiratory InsufficiencyNCT01747954
Effects of Physiotherapy in Hemodynamics and Childrens Respiratory Mechanics
A study testing Bag Squeezing and Thoracic vibrocompression in people with Respiratory Insufficiency and Children, run by Federal University of Uberlandia.
Trial summary
The hypothesis of this study is that respiratory physiotherapy can promote improvement in respiratory mechanics in children with respiratory failure and the bag squeezing maneuver is more effective in improving respiratory mechanics in childrens and does not alter the hemodynamic proved safe Read more about this study
- Who is it for?
- Ages 1 month to 60 monthsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Insufficiency, Children
- What is being tested?
- Bag Squeezing and Thoracic vibrocompression
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Mar 2010to Jan 2012
- 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 1 month to 60 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children aged between one and 60 months
- diagnosed with respiratory failure
- undergoing mechanical ventilation
Who cannot join
- had traumatic brain injury
- severe thrombocytopenia (<20,000 pl/mm³)
- hypovolemia and cyanogenic congenital heart defects
- pneumothorax, hemothorax and/or pleural effusion without previous drainage
About this study
Official title: Respiratory Mechanics and Hemodynamics in Children With Respiratory Failure: Comparison of Two Techniques of Respiratory Physiotherapy
The hypothesis of this study is that respiratory physiotherapy can promote improvement in respiratory mechanics in children with respiratory failure and the bag squeezing maneuver is more effective in improving respiratory mechanics in childrens and does not alter the hemodynamic proved safe
- Conditions
- Respiratory Insufficiency, Children
- Being tested
- Bag Squeezing, Thoracic vibrocompression
- Keywords
- Respiratory Insufficiency, Physiotherapy Techniques, Respiratory Mechanics
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bag SqueezingOther
Also called BS
To perform the BS technique, we used a Protec® manual inflation bag with a flow of 10 L / min and 100% oxygen. A Commercial Medical® manometer was adapted between the orotracheal tube and the inflation bag to monitor the inflation pressure which was recommendedat 30 cmH2O for all children of the BS group. Initially we instilled at most 0.5 ml saline solution(SS) at 0.9% followed by 10 manual hyperinflation maneuvers interspersed with 10 vibrocompression maneuvers and as a last procedure, we performed an aspiration of the orotracheal tube airways and mouth. Between the aspirations the child was re-connected to the ventilator.
Thoracic vibrocompressionOther
Also called TVC
To perform the TVC technique, we applied 10 vibrocompression maneuvers on the chest of the children during the expiratory phase of the respiratory cycle, on each of the lateral decubitus position, totaling 20 maneuvers, followed by aspiration in the dorsal decubitus position. All measurements in both study groups were performed with the child connected to the ventilator. Before starting the maneuver BS or TVC the child received an increase of 20% fraction of inspired oxygen (FiO2) from what was received previously in MV and after data collection FiO2 returned to baseline values.
| Study group | Role | What they receive |
|---|---|---|
| Bag Squeezing | Experimental | * 20% increase in FiO2
* Inflation pressure of 30 cm H2O + 10l O2/min
* 0.5 ml saline 0.9%
* 10 Manual Hyperinflation
* 10 vibrocompression
* Aspiration Tracheal Receives: Other: Thoracic vibrocompression |
| Thoracic vibrocompression | Active comparator | * 20% increase in FiO2
* 0.5 ml saline
* 10 vibrocompression toracica on the right and left
* Aspiration Tracheal Receives: Other: Bag Squeezing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of Bag Squeezing and vibrocompression chest in hemodynamic, resistance and respiratory system compliance
All variables were assessed prior to the proposed technique (pre-maneuver), immediately after the execution of the technique randomly chosen (post-maneuver), 30, 60 and 120 after the end of the technique randomly chosen. The mean of three readings was used as the representative value for each variable. All children were ventilated with the same mechanical Dixtal® DX3020 Brazil ventilator
Measured: one hundred twenty minutes
Secondary outcomes (1)
comparing all variables between the two groups
Measured: one hundred twenty minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2012 (estimated)
- Study startMar 2010
- Primary completionSep 2011
- Study completionJan 2012
Why it stopped: Terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory InsufficiencyStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Uberlandia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Letícia de Queiroz Martins, Federal University of Uberlandia
- Investigators
- Letícia Martins, Principal investigator, Federal University of Uberlandia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01747954
- Sponsor's protocol ID
- 11112PSC009
- Status last verified
- Nov 2012
- First submitted
- 16 Nov 2012
- Last updated
- 21 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Mechanics and Hemodynamics in Children With Respiratory Failure: Comparison of Two Techniques of Respiratory Physiotherapy
- ClinicalTrials.gov ID
- NCT01747954
- Acronym / sponsor ID
- 11112PSC009
- Conditions
- Respiratory Insufficiency, Children
- Keywords
- Respiratory Insufficiency, Physiotherapy Techniques, Respiratory Mechanics
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Federal University of UberlandiaUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 12 Dec 2012 (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.
The hypothesis of this study is that respiratory physiotherapy can promote improvement in respiratory mechanics in children with respiratory failure and the bag squeezing maneuver is more effective in improving respiratory mechanics in childrens and does not alter the hemodynamic proved safe
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bag Squeezing | Experimental | Other: Thoracic vibrocompression* 20% increase in FiO2 * Inflation pressure of 30 cm H2O + 10l O2/min * 0.5 ml saline 0.9% * 10 Manual Hyperinflation * 10 vibrocompression * Aspiration Tracheal |
| Thoracic vibrocompression | Active comparator | Other: Bag Squeezing* 20% increase in FiO2 * 0.5 ml saline * 10 vibrocompression toracica on the right and left * Aspiration Tracheal |
Who may qualify
- Ages
- 1 month to 60 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children aged between one and 60 months
- diagnosed with respiratory failure
- undergoing mechanical ventilation
Key exclusion criteria (4 listed)
- had traumatic brain injury
- severe thrombocytopenia (<20,000 pl/mm³)
- hypovolemia and cyanogenic congenital heart defects
- pneumothorax, hemothorax and/or pleural effusion without previous drainage
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 |
|---|---|---|
| Bag SqueezingAlso: BSTo perform the BS technique, we used a Protec® manual inflation bag with a flow of 10 L / min and 100% oxygen. A Commercial Medical® manometer was adapted between the orotracheal tube and the inflation bag to monitor the inflation pressure which was recommendedat 30 cmH2O for all children of the BS group. Initially we instilled at most 0.5 ml saline solution(SS) at 0.9% followed by 10 manual hyperinflation maneuvers interspersed with 10 vibrocompression maneuvers and as a last procedure, we performed an aspiration of the orotracheal tube airways and mouth. Between the aspirations the child was re-connected to the ventilator. | Other | Thoracic vibrocompression |
| Thoracic vibrocompressionAlso: TVCTo perform the TVC technique, we applied 10 vibrocompression maneuvers on the chest of the children during the expiratory phase of the respiratory cycle, on each of the lateral decubitus position, totaling 20 maneuvers, followed by aspiration in the dorsal decubitus position. All measurements in both study groups were performed with the child connected to the ventilator. Before starting the maneuver BS or TVC the child received an increase of 20% fraction of inspired oxygen (FiO2) from what was received previously in MV and after data collection FiO2 returned to baseline values. | Other | Bag Squeezing |
Primary outcome
Effects of Bag Squeezing and vibrocompression chest in hemodynamic, resistance and respiratory system compliance
Time frame: one hundred twenty minutes
All variables were assessed prior to the proposed technique (pre-maneuver), immediately after the execution of the technique randomly chosen (post-maneuver), 30, 60 and 120 after the end of the technique randomly chosen. The mean of three readings was used as the representative value for each variable. All children were ventilated with the same mechanical Dixtal® DX3020 Brazil ventilator
1 secondary outcome
comparing all variables between the two groups
Time frame: one hundred twenty minutes
Results and safety
The study was stopped early (reason given: Terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2012.
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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.
Letícia Martins principal investigator
Federal University of Uberlandia
Questions about this trial
What is this clinical trial studying?
A study testing Bag Squeezing and Thoracic vibrocompression in people with Respiratory Insufficiency and Children, run by Federal University of Uberlandia.
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 4 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: stopped early, as of the sponsor's last update on 21 Dec 2012. 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 was stopped early (reason given: Terminated). Results are not available in the source record.
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?
Effects of Bag Squeezing and vibrocompression chest in hemodynamic, resistance and respiratory system compliance (time frame: one hundred twenty minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Dec 2012.