Respiratory FailurePhase 4NCT01204281
Proportional Assist Ventilation (PAV) in Early Stage of Critically Ill Patients
A Phase 4 study testing Mechanical ventilation mode (PAV+ vs. ACV) in people with Respiratory Failure and Mechanical Ventilation, run by Althaia Xarxa Assistencial Universitària de Manresa at 1 site in Spain.
Trial summary
To evaluate the effectiveness of high assistance proportional assist ventilation (PAV+) (objective 80% gain) as main ventilatory support in early stage of critically ill patients in comparison with standard volume-assist control ventilation (ACV). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Respiratory Failure, Mechanical Ventilation
- What is being tested?
- Mechanical ventilation mode (PAV+ vs. ACV)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2010to Sep 2012
- Phase
- Phase 4
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 years of age or older
- Anticipated MV > 24 hours
- Availability of informed consent from patient or next of kin
- Ventilation parameters measured under PAV+ 80% gain:
- PaO2/FiO2 >100 RPAV <10 cm H2O/l/s CPAV > 30 ml/cm H2O WOBTOT <1.5 J/l VE <18 l/min
Who cannot join
- Patients on moribund state or with life-sustaining therapy withholding decision.
- Patients with unstable respiratory/hemodynamic state, PaO2/FiO2 <100, Dopamine >15 microg/Kg/min or epinephrine >0.1 microg/kg/min.
- Pregnancy.
- Air leak.
- Patients needing deep sedation or muscle paralysis
- Patients needing hyperventilation (brain trauma).
- Patients with severe muscle weakness.
- Recruitment maneuvers or prone position.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Intensive Care Unit. Xarxa assistencial Althaia.
Manresa, Catalonia, 08243
About this study
Official title: High-assistance Proportional Assist Ventilation (PAV) vs. Assist-Control Ventilation (ACV) in Early Stage of Critically Ill Patients
To evaluate the effectiveness of high assistance proportional assist ventilation (PAV+) (objective 80% gain) as main ventilatory support in early stage of critically ill patients in comparison with standard volume-assist control ventilation (ACV).
Read the detailed description
The goal of this proposal is to apply PAV+ as routine ventilatory mode in the early stage of critically ill patients, taking advantages of spontaneous breathing and better patient-ventilator interaction.
The standard treatment in patients with acute respiratory failure is mechanical ventilation in control-mode for the first days of acute illness. This procedure is usually associated with patient-ventilator dyssynchrony, higher needs of sedation and/or relaxation, muscle atrophy, etc. PAV + is a new ventilatory mode that applies pressure in proportion to spontaneous patient inspiratory effort allowing better adaptation to changes in internal homeostasis.
Up to now, several reports compare PAV with assisted modes as a feasible alternative only in the weaning phase. However, PAV is able to unload patient effort in different levels, suggesting that high-assistance PAV (about 80%) could be comparable with assist-control modes in terms of respiratory muscles unload.
Whether PAV is as effective as traditional ACV in terms of ventilation muscle unload in the acute phase of illness has not been established and we aim to address this question.
We plan to prospectively enroll patients on mechanical ventilation early at ICU admission, and to ventilate them randomly under ACV (volume-assist control ventilation) or PAV+ (beginning with 80% if possible). We will evaluate length of mechanical ventilation, sedation requirements and respiratory-hemodynamic variables from the very beginning and until attending clinicians decide that patients are ready to be weaned.
- Conditions
- Respiratory Failure, Mechanical Ventilation
- Being tested
- Mechanical ventilation mode (PAV+ vs. ACV)
- Keywords
- Proportional Assist Ventilation plus, Acute respiratory failure, Mechanical ventilation
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical ventilation mode (PAV+ vs. ACV)Other
Also called Proportional Assist ventilation (PAV+), Assist Control ventilation, Critically ill patients, Mechanical ventilation
Compare two ventilatory modes in the acute phase of illness
| Study group | Role | What they receive |
|---|---|---|
| High assistance PAV+ | Experimental | Ventilatory support performed by PAV at 80% assistance (PB 840-plus) FiO2 and PEEP according to routine practice Receives: Other: Mechanical ventilation mode (PAV+ vs. ACV) |
| Assist-control ventilation | Active comparator | Tidal volume, FiO2 and PEEP set according to routine practice Receives: Other: Mechanical ventilation mode (PAV+ vs. ACV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of mechanical ventilation
Reduction of mechanical ventilation days when ventilated with high assistance PAV+ compared with ACV.
Measured: 28 days
Secondary outcomes (3)
Non-inferiority of PAV+ compared to ACV in terms of gas exchange
Non-inferiority of high assistance PAV+ compared to ACV in terms of gas exchange
Measured: 28 days
Noninferiority of PAV in short term complications
Similar incidence in the complications composite outcome (barotrauma, ARDS, atelectasis and pneumonia)
Measured: 28 days
Noninferiority of PAV in weaning success
Similar rate of weaning success defined as the composite end-point: time to resume spontaneous ventilation, rate of extubation success, need for non invasive ventilation (NIV) as rescue therapy, and reintubation rate.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Respiratory FailureStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Althaia Xarxa Assistencial Universitària de Manresa
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic - MITG
- Responsible party
- Principal investigator, Rafael Fernandez, Althaia Xarxa Assistencial Universitària de Manresa
- Investigators
- Rafael Fernandez, M.D., Principal investigator, Althaia Xarxa Assistencial Universitària de Manresa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01204281
- Sponsor's protocol ID
- CEIC 10-48
- Status last verified
- Nov 2012
- First submitted
- 15 Sep 2010
- Last updated
- 27 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Grasso S, Puntillo F, Mascia L, Ancona G, Fiore T, Bruno F, Slutsky AS, Ranieri VM. Compensation for increase in respiratory workload during mechanical ventilation. Pressure-support versus proportional-assist ventilation. Am J Respir Crit Care Med. 2000 Mar;161(3 Pt 1):819-26. doi: 10.1164/ajrccm.161.3.9902065.
PubMed 10712328Georgopoulos, D., Plataki, M., Prinianakis, G., Kondili, E., Current status of proportional assist ventilation. International journal of Intensive Care, 2007. Autumn: p. 19-26.
Delgado M, Zavala E, Tomas R, Fernandez R. "Feasibility of proportional assist ventilation as routine ventilatory support in intensive care patients". Intensive Care Med 2009; 35; Suppl 1: S125
Putensen C, Muders T, Varelmann D, Wrigge H. The impact of spontaneous breathing during mechanical ventilation. Curr Opin Crit Care. 2006 Feb;12(1):13-8. doi: 10.1097/01.ccx.0000198994.37319.60.
PubMed 16394778Younes M. Proportional-assist ventilation. In: Tobin MJ, editor. Principles and practice of mechanical ventilation. Illinois: McGraw-Hill; 2006. p. 335-64.
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-assistance Proportional Assist Ventilation (PAV) vs. Assist-Control Ventilation (ACV) in Early Stage of Critically Ill Patients
- ClinicalTrials.gov ID
- NCT01204281
- Acronym / sponsor ID
- CEIC 10-48
- Conditions
- Respiratory Failure, Mechanical Ventilation
- Keywords
- Proportional Assist Ventilation plus, Acute respiratory failure, Mechanical ventilation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Althaia Xarxa Assistencial Universitària de ManresaUniversity, hospital or other
- Collaborators
- Medtronic - MITG
- Study start
- Sep 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 17 Sep 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.
To evaluate the effectiveness of high assistance proportional assist ventilation (PAV+) (objective 80% gain) as main ventilatory support in early stage of critically ill patients in comparison with standard volume-assist control ventilation (ACV).
Detailed description
The goal of this proposal is to apply PAV+ as routine ventilatory mode in the early stage of critically ill patients, taking advantages of spontaneous breathing and better patient-ventilator interaction.
The standard treatment in patients with acute respiratory failure is mechanical ventilation in control-mode for the first days of acute illness. This procedure is usually associated with patient-ventilator dyssynchrony, higher needs of sedation and/or relaxation, muscle atrophy, etc. PAV + is a new ventilatory mode that applies pressure in proportion to spontaneous patient inspiratory effort allowing better adaptation to changes in internal homeostasis.
Up to now, several reports compare PAV with assisted modes as a feasible alternative only in the weaning phase. However, PAV is able to unload patient effort in different levels, suggesting that high-assistance PAV (about 80%) could be comparable with assist-control modes in terms of respiratory muscles unload.
Whether PAV is as effective as traditional ACV in terms of ventilation muscle unload in the acute phase of illness has not been established and we aim to address this question.
We plan to prospectively enroll patients on mechanical ventilation early at ICU admission, and to ventilate them randomly under ACV (volume-assist control ventilation) or PAV+ (beginning with 80% if possible). We will evaluate length of mechanical ventilation, sedation requirements and respiratory-hemodynamic variables from the very beginning and until attending clinicians decide that patients are ready to be weaned.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High assistance PAV+ | Experimental | Other: Mechanical ventilation mode (PAV+ vs. ACV)Ventilatory support performed by PAV at 80% assistance (PB 840-plus) FiO2 and PEEP according to routine practice |
| Assist-control ventilation | Active comparator | Other: Mechanical ventilation mode (PAV+ vs. ACV)Tidal volume, FiO2 and PEEP set according to routine practice |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients 18 years of age or older
- Anticipated MV > 24 hours
- Availability of informed consent from patient or next of kin
- Ventilation parameters measured under PAV+ 80% gain:
- PaO2/FiO2 >100 RPAV <10 cm H2O/l/s CPAV > 30 ml/cm H2O WOBTOT <1.5 J/l VE <18 l/min
Key exclusion criteria (8 listed)
- Patients on moribund state or with life-sustaining therapy withholding decision.
- Patients with unstable respiratory/hemodynamic state, PaO2/FiO2 <100, Dopamine >15 microg/Kg/min or epinephrine >0.1 microg/kg/min.
- Pregnancy.
- Air leak.
- Patients needing deep sedation or muscle paralysis
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 |
|---|---|---|
| Mechanical ventilation mode (PAV+ vs. ACV)Also: Proportional Assist ventilation (PAV+), Assist Control ventilation, Critically ill patients, Mechanical ventilationCompare two ventilatory modes in the acute phase of illness | Other | Assist-control ventilation, High assistance PAV+ |
Primary outcome
Length of mechanical ventilation
Time frame: 28 days
Reduction of mechanical ventilation days when ventilated with high assistance PAV+ compared with ACV.
3 secondary outcomes
Non-inferiority of PAV+ compared to ACV in terms of gas exchange
Time frame: 28 days
Noninferiority of PAV in short term complications
Time frame: 28 days
Noninferiority of PAV in weaning success
Time frame: 28 days
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 27 Nov 2012.
- Results publication: PubMed 10712328Grasso S, Puntillo F, Mascia L, Ancona G, Fiore T, Bruno F, Slutsky AS, Ranieri VM. Compensation for increase in respiratory workload during mechanical ventilation. Pressure-support versus proportional-assist ventilation. Am J Respir Crit Care Med. 2000 Mar;161(3 Pt 1):819-26. doi: 10.1164/ajrccm.161.3.9902065.
- Results publicationGeorgopoulos, D., Plataki, M., Prinianakis, G., Kondili, E., Current status of proportional assist ventilation. International journal of Intensive Care, 2007. Autumn: p. 19-26.
- Results publicationDelgado M, Zavala E, Tomas R, Fernandez R. "Feasibility of proportional assist ventilation as routine ventilatory support in intensive care patients". Intensive Care Med 2009; 35; Suppl 1: S125
- Results publication: PubMed 16394778Putensen C, Muders T, Varelmann D, Wrigge H. The impact of spontaneous breathing during mechanical ventilation. Curr Opin Crit Care. 2006 Feb;12(1):13-8. doi: 10.1097/01.ccx.0000198994.37319.60.
- Results publicationYounes M. Proportional-assist ventilation. In: Tobin MJ, editor. Principles and practice of mechanical ventilation. Illinois: McGraw-Hill; 2006. p. 335-64.
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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.
Rafael Fernandez, M.D. principal investigator
Althaia Xarxa Assistencial Universitària de Manresa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mechanical ventilation mode (PAV+ vs. ACV) in people with Respiratory Failure and Mechanical Ventilation, run by Althaia Xarxa Assistencial Universitària de Manresa at 1 site in Spain.
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 5 inclusion and 8 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 27 Nov 2012. 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 Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Length of mechanical ventilation (time frame: 28 days). 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 NCT01204281, which also lists 5 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 27 Nov 2012.