Respiration, ArtificialNCT01155648
Pressure Support During Chest Wall Compression
A study testing Chest wall compression plus increase of 10 cmH2O in inspiratory pressure during Pressure Support Ventilation for ten minutes in chest. and Chest wall compression for ten minutes in chest in people with Respiration, Artificial and Critical Care, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
The purpose of this study is to compare two physiotherapy techniques: chest wall compression versus chest wall compression plus increase of 10 cmH2O in inspiratory pressure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiration, Artificial, Critical Care
- What is being tested?
- Chest wall compression plus increase of 10 cmH2O in inspiratory pressure during Pressure Support Ventilation for ten minutes in chest. and Chest wall compression for ten minutes in chest
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteBrazil
- Study dates
- May 2008to May 2010
- 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
- Patients on mechanical ventilation over 48 hours
- With ventilatory drive
- Hemodynamically stable MAP> 60 mmHg
- With treatment of respiratory therapy
Who cannot join
- Contra indication of increased positive inspiratory pressure
- Peak pressure in the upper airway > 40 cmH2O
- Osteoporosis diagnosis
- Deny to participate in the study
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Rio Grande do Sul, Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
About this study
Official title: Increasing Pressure Support During Chest Wall Compression is Useful During Respiratory Therapy?
The purpose of this study is to compare two physiotherapy techniques: chest wall compression versus chest wall compression plus increase of 10 cmH2O in inspiratory pressure.
Read the detailed description
- After being placed in the supine position in bed, with head angle elevation at 30°, patients were randomized to:group 1 (G1): chest wall compression for ten minutes in chest or group 2 (G2): chest wall compression plus increase of 10 cmH2O in IP in PSV for ten minutes in chest.
- Clinical variables and APACHE II were registered.
- Parameters analyzed at the beginning (1) and at the end (2) of the protocol were: variation of peak pressure (ΔPp=Pp2-Pp1),variation of tidal volume (ΔVT =VT2-VT1), variation of dynamic compliance (ΔCdyn= Cdyn2-Cdyn1).
- The amount of variation of mucus secretion aspirated (ΔSa= Sa2-Sa1) at the end was also measured
- Conditions
- Respiration, Artificial, Critical Care
- Being tested
- Chest wall compression plus increase of 10 cmH2O in inspiratory pressure during Pressure Support Ventilation for ten minutes in chest., Chest wall compression for ten minutes in chest
- Keywords
- Mechanical ventilation, Chest physiotherapy, Chest wall compression
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest wall compression plus increase of 10 cmH2O in inspiratory pressure during Pressure Support Ventilation for ten minutes in chest.Device
Chest wall compression for ten minutes in chestDevice
| Study group | Role | What they receive |
|---|---|---|
| PSV group. | Experimental | Chest wall compression plus increase of 10 cmH2O of PSV. Receives: Device: Chest wall compression plus increase of 10 cmH2O in inspiratory pressure during Pressure Support Ventilation for ten minutes in chest. |
| chest wall compression group | Active comparator | Chest wall compression Receives: Device: Chest wall compression for ten minutes in chest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of mucus secretion aspirated.
Measured: Two years
Secondary outcomes (1)
Hemodynamic and pulmonary parameters.
The hemodynamic and pulmonary parameters were collected: Hart rate (HH), respiratory rate (f), mean arterial pressure (MAP) and peripheral arterial saturation of oxygen (SpO2); peak inspiratory pressure (Ppeak),and Tidal volume (VT) measured in the ventilator, dynamic compliance (Cdyn calculated through the formula VT/ Ppeak - PEEP)
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2010 (estimated)
- Study startMay 2008
- Primary completionJun 2009
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Respiration, ArtificialStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Investigators
- Silvia R Vieira, PhD, Principal investigator, Federal University of Rio Grande do Sul, Hospital de Clínicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01155648
- Sponsor's protocol ID
- 07-504
- Status last verified
- Jun 2010
- First submitted
- 23 Jun 2010
- Last updated
- 2 Jul 2010
- 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 24626270Naue Wda S, da Silva AC, Guntzel AM, Condessa RL, de Oliveira RP, Rios Vieira SR. Increasing pressure support does not enhance secretion clearance if applied during manual chest wall vibration in intubated patients: a randomised trial. J Physiother. 2011;57(1):21-6. doi: 10.1016/S1836-9553(11)70003-0.
PubMed 21402326
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Pressure Support During Chest Wall Compression is Useful During Respiratory Therapy?
- ClinicalTrials.gov ID
- NCT01155648
- Acronym / sponsor ID
- 07-504
- Conditions
- Respiration, Artificial, Critical Care
- Keywords
- Mechanical ventilation, Chest physiotherapy, Chest wall compression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 2 Jul 2010 (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 purpose of this study is to compare two physiotherapy techniques: chest wall compression versus chest wall compression plus increase of 10 cmH2O in inspiratory pressure.
Detailed description
- After being placed in the supine position in bed, with head angle elevation at 30°, patients were randomized to:group 1 (G1): chest wall compression for ten minutes in chest or group 2 (G2): chest wall compression plus increase of 10 cmH2O in IP in PSV for ten minutes in chest.
- Clinical variables and APACHE II were registered.
- Parameters analyzed at the beginning (1) and at the end (2) of the protocol were: variation of peak pressure (ΔPp=Pp2-Pp1),variation of tidal volume (ΔVT =VT2-VT1), variation of dynamic compliance (ΔCdyn= Cdyn2-Cdyn1).
- The amount of variation of mucus secretion aspirated (ΔSa= Sa2-Sa1) at the end was also measured
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PSV group. | Experimental | Device: Chest wall compression plus increase of 10 cmH2O in inspiratory pressure during Pressure Support Ventilation for ten minutes in chest.Chest wall compression plus increase of 10 cmH2O of PSV. |
| chest wall compression group | Active comparator | Device: Chest wall compression for ten minutes in chestChest wall compression |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients on mechanical ventilation over 48 hours
- With ventilatory drive
- Hemodynamically stable MAP> 60 mmHg
- With treatment of respiratory therapy
Key exclusion criteria (4 listed)
- Contra indication of increased positive inspiratory pressure
- Peak pressure in the upper airway > 40 cmH2O
- Osteoporosis diagnosis
- Deny to participate in the study
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 |
|---|---|---|
| Chest wall compression plus increase of 10 cmH2O in inspiratory pressure during Pressure Support Ventilation for ten minutes in chest. | Device | PSV group. |
| Chest wall compression for ten minutes in chest | Device | chest wall compression group |
Primary outcome
Variation of mucus secretion aspirated.
Time frame: Two years
1 secondary outcome
Hemodynamic and pulmonary parameters.
Time frame: Two years
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 2 Jul 2010.
- Derived from this study: 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.
- Derived from this study: PubMed 21402326Naue Wda S, da Silva AC, Guntzel AM, Condessa RL, de Oliveira RP, Rios Vieira SR. Increasing pressure support does not enhance secretion clearance if applied during manual chest wall vibration in intubated patients: a randomised trial. J Physiother. 2011;57(1):21-6. doi: 10.1016/S1836-9553(11)70003-0.
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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.
Silvia R Vieira, PhD principal investigator
Federal University of Rio Grande do Sul, Hospital de Clínicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chest wall compression plus increase of 10 cmH2O in inspiratory pressure during Pressure Support Ventilation for ten minutes in chest. and Chest wall compression for ten minutes in chest in people with Respiration, Artificial and Critical Care, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 4 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: finished, as of the sponsor's last update on 2 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Variation of mucus secretion aspirated. (time frame: Two years). 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 NCT01155648, which also lists 2 linked publications.
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 2 Jul 2010; AzTrials last refreshed its copy on 27 Oct 2026.