Cardiac Output, LowNCT01892696
Effects of Inspiratory Flow Waveforms on Preload
A study testing varying inspiratory flow waveforms in people with Cardiac Output, Low, run by Military Hospital of Tunis at 1 site in Tunisia.
Trial summary
The clinical usefulness of inspiratory flow pattern manipulation during mechanical ventilation remains unclear. The aim of this study was to investigate the effects of different inspiratory flow waveforms, i.e. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiac Output, Low
- What is being tested?
- varying inspiratory flow waveforms
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTunisia
- Study dates
- May 2013to Aug 2013
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- mechanical ventilation
- Volume AssistControl Ventilation
- sinus rhythm
Who cannot join
- pressure mode
- arrhythmia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Arterial Pulse Pressure Variation and Inferior Vena Cava Distensibility Affected by Inspiratory Flow Waveforms in Mechanically Ventilated Patients: Time for a Change
The clinical usefulness of inspiratory flow pattern manipulation during mechanical ventilation remains unclear. The aim of this study was to investigate the effects of different inspiratory flow waveforms, i.e. constant and decelerating, on cardiac preload in mechanically ventilated patients assessed by arterial pulse pressure variation (PPV) and inferior vena cava distensibility.
Read the detailed description
During mechanical ventilation the lungs can be inflated with different pressure and flow waveforms. Originally the piston-driven mechanical ventilators generated a quasi-sinusoidal flow waveform, whereas the newer electronically controlled ventilators can also produce constant and decelerating waveforms. According to several theoretical,animal and clinical studies,the inspiratory flow waveform affects the distribution of the inspired gas as well as respiratory mechanics and gas exchange. However, other studies failed to show any significant effect.But there is no study interested to the effects of inspiratory flow waveforms on cardiac preload. Thus, the clinical usefulness of inspiratory flow pattern manipulation remains unclear, though the capacity for selection of different inspiratory flow waveforms is provided by most modern, microprocessor-equipped ventilators. Therefore, the purpose of this study was to compare the effects of flow patterns (sinusoidal, constant and decelerating) on dynamic measurements of cardiac preload dependence such as arterial pulse pressure variation (ΔPP) and distensibility index of the inferior vena cava (dIVC).
- Conditions
- Cardiac Output, Low
- Being tested
- varying inspiratory flow waveforms
- Keywords
- inspiratory flow pattern, mechanical ventilation, cardiac preload, arterial pulse pressure variation, inferior vena cava collapsibility
- Medical subject headings
- Cardiac Output, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
varying inspiratory flow waveformsDevice
inspiratory flow waveform was changed, in a randomized sequence using a computer ,to one of the following modalities: 1) constant inspiratory flow; 2) decelerating inspiratory flow Each inspiratory flow waveform was maintained for 30 min. During the last 5 min of this period the physiological signals were collected and measures were performed.
| Study group | Role | What they receive |
|---|---|---|
| mechanically ventilated patients | Other | patients admitted to a 18-bed medical surgical intensive care unit of the military hospital of Tunisia and were mechanically ventilated fully adapted to their ventilator and in sinus rhythm.
intervention:varying inspiratory flow waveforms Receives: Device: varying inspiratory flow waveforms |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in pulse pressure variation (ΔPP) and distensibility index of the inferior vena cava (dIVC)when varying inspiratory flow waveforms
Each inspiratory flow waveform was maintained for 30 min with 60 minutes washout period
Measured: 2h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2013 (estimated)
- Study startMay 2013
- Primary completionJul 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Output, LowStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Military Hospital of Tunis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hajjej Zied, Military Hospital of Tunis
- Investigators
- zied hajjej, Dr, Principal investigator, Military Hospital of Tunis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01892696
- Sponsor's protocol ID
- CvDVPPIVC
- Other IDs
- CvD1977
- Status last verified
- Nov 2016
- First submitted
- 26 Jun 2013
- Last updated
- 9 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arterial Pulse Pressure Variation and Inferior Vena Cava Distensibility Affected by Inspiratory Flow Waveforms in Mechanically Ventilated Patients: Time for a Change
- ClinicalTrials.gov ID
- NCT01892696
- Acronym / sponsor ID
- CvDVPPIVC
- Conditions
- Cardiac Output, Low
- Keywords
- inspiratory flow pattern, mechanical ventilation, cardiac preload, arterial pulse pressure variation, inferior vena cava collapsibility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Military Hospital of TunisUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 4 Jul 2013 (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 clinical usefulness of inspiratory flow pattern manipulation during mechanical ventilation remains unclear. The aim of this study was to investigate the effects of different inspiratory flow waveforms, i.e. constant and decelerating, on cardiac preload in mechanically ventilated patients assessed by arterial pulse pressure variation (PPV) and inferior vena cava distensibility.
Detailed description
During mechanical ventilation the lungs can be inflated with different pressure and flow waveforms. Originally the piston-driven mechanical ventilators generated a quasi-sinusoidal flow waveform, whereas the newer electronically controlled ventilators can also produce constant and decelerating waveforms. According to several theoretical,animal and clinical studies,the inspiratory flow waveform affects the distribution of the inspired gas as well as respiratory mechanics and gas exchange. However, other studies failed to show any significant effect.But there is no study interested to the effects of inspiratory flow waveforms on cardiac preload. Thus, the clinical usefulness of inspiratory flow pattern manipulation remains unclear, though the capacity for selection of different inspiratory flow waveforms is provided by most modern, microprocessor-equipped ventilators. Therefore, the purpose of this study was to compare the effects of flow patterns (sinusoidal, constant and decelerating) on dynamic measurements of cardiac preload dependence such as arterial pulse pressure variation (ΔPP) and distensibility index of the inferior vena cava (dIVC).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mechanically ventilated patients | Other | Device: varying inspiratory flow waveformspatients admitted to a 18-bed medical surgical intensive care unit of the military hospital of Tunisia and were mechanically ventilated fully adapted to their ventilator and in sinus rhythm. intervention:varying inspiratory flow waveforms |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- mechanical ventilation
- Volume AssistControl Ventilation
- sinus rhythm
Key exclusion criteria (2 listed)
- pressure mode
- arrhythmia
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 |
|---|---|---|
| varying inspiratory flow waveformsinspiratory flow waveform was changed, in a randomized sequence using a computer ,to one of the following modalities: 1) constant inspiratory flow; 2) decelerating inspiratory flow Each inspiratory flow waveform was maintained for 30 min. During the last 5 min of this period the physiological signals were collected and measures were performed. | Device | mechanically ventilated patients |
Primary outcome
change in pulse pressure variation (ΔPP) and distensibility index of the inferior vena cava (dIVC)when varying inspiratory flow waveforms
Time frame: 2h
Each inspiratory flow waveform was maintained for 30 min with 60 minutes washout period
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 9 Nov 2016.
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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.
zied hajjej, Dr principal investigator
Military Hospital of Tunis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing varying inspiratory flow waveforms in people with Cardiac Output, Low, run by Military Hospital of Tunis at 1 site in Tunisia.
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 2 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 9 Nov 2016. 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 Tunisia. 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?
change in pulse pressure variation (ΔPP) and distensibility index of the inferior vena cava (dIVC)when varying inspiratory flow waveforms (time frame: 2h). 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 9 Nov 2016.