Mechanical Ventilation ComplicationNCT03360968
Heartrate Variability During Conventional and Variable Pressure Support Mechanical Ventilation
A study testing Variable-PS and SPN-CPAP/PS in people with Mechanical Ventilation Complication, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Rationale Studies show that about a third of all postoperative complications are due to cardiovascular reasons. Furthermore it was shown that more than 50% of postoperative deaths are associated with severe cardiovascular incidents. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Mechanical Ventilation Complication
- What is being tested?
- Variable-PS and SPN-CPAP/PS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteAustria
- Study dates
- 6 Feb 2018to 31 Dec 2020
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing therapy at an ICU; patients intubated and ventilated using SPN-CPAP/PS ventilator mode; patients with sinus rhythm in electrocardiogram
Who cannot join
- patients with active heart pace maker / defibrillator; patients with absent sinus rhythm in electrocardiogram; patients with known severe disease of autonomous nervous system
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Heartrate Variability During Conventional and Variable Pressure Support Mechanical Ventilation: a Cross-over Study
Rationale Studies show that about a third of all postoperative complications are due to cardiovascular reasons. Furthermore it was shown that more than 50% of postoperative deaths are associated with severe cardiovascular incidents. After surgical interventions seriously ill patients are transferred to intensive care units and mechanically ventilated. However there is not much evidence about the impact of mechanical ventilation on the cardiovascular system and cardiovascular complications. Artificial mechanical ventilation greatly differs from physiological breathing. In contrast to physiological negative pressure ventilation of th lung, mechanical positive pressure ventilation can cause ventilator induced lung injuries. Furthermore a significant deterioration of lung-heart-interaction during mechanical ventilation is known.
Relevance Mechanical ventilation leads to a decreased heartrate-variability, which has to be understood as increased stress on the cardiovascular system. Recently, a new ventilation mode called "variable pressure support ventilation" (VPSV) also known as "noisy pressure support ventilation". This new ventilation mode is similar to the ventilator mode "spontaneous-continuous positive airway pressure/pressure support" (SPN-CPAP), which is often used in a intensive care unit routine. Though VPSV differs through varying applicated pressure support and therefore tidal volumes. Therefore the new ventilation mode rather imitates physiological situation, since tidal volumes vary in physiological breathing, which has positive impact on heart-lung-interaction.
Read the detailed description
Spontaneous-continuous positive airway pressure support (SPN-CPAP/PS) is the routine ventilator mode used in critically ill patients submitted to an intensive care unit (ICU). It guarantees a positive end expiratory pressure, which prevents atelectasis and minimizes weaning time, by supporting the patient's respiratory drive.
A few years ago, this very established ventilation technique was modified by simply altering the rhythm and volume of gas application: instead of administering same tidal volumes in equal time intervals a variation of applied volume as well as altering frequency in ventilation is introduced. This ventilation method is termed noisy pressure support ventilation (noisy PSV) or variable pressure support ventilation (variable PSV). The variation of pressure support will be within a range around a mean support-pressure (Psupp) and won't exceed a maximum pressure (Pmax), which are both adjusted before starting noisy PSV.
Any variation of breathing is physiological and may occur during speaking, moving and many other factors. As novel concept, the investigator proposes that such variation of ventilation rhythm and volume may have an important impact on heart rate variability (HRV), which is known as to be an indicator of a healthy heart. Since it has been observed that HRV is an important predictor of mortality in coronary care units, investigation of HRV became more important. Recently it was found that low HRV is associated with an increasing mortality and proposed low HRV to be a marker for critical illness.
The analysis and further investigation of HRV has therefore become an important issue in modern medicine. Mechanical ventilation plays a pivotal role in ICUs and should be further improved. Mechanical ventilation per se is stressful for the cardiovascular system. Cardiovascular homeostasis is of major importance and the investigator hypothesises that noisy PSV will decrease the stress applied to the human heart measured via heart rate variability.
In this interventional clinical study, the investigator will apply, in a randomized fashion, conventional PSV and variable PSV each for a duration of one hour. During ventilation the investigator will record all data of the patients monitor, including the electrocardiogram (ECG), which is routinely monitored in patients, and respiratory data, to determine HRV parameters retrospectively. All other ventilatory, hemodynamic and pharmacological treatment will be part of the clinical routine. As two modes of ventilation will be compared, this study is an interventional clinical trial.
- Conditions
- Mechanical Ventilation Complication
- Being tested
- Variable-PS, SPN-CPAP/PS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Variable-PSProcedure or surgery
Variable-PS mode switched on for 1 hour
SPN-CPAP/PSProcedure or surgery
SPN-CPAP/PS mode switched on for 1 hour
Variable-PSProcedure or surgery
Variable-PS mode switched on for 1 hour
| Study group | Role | What they receive |
|---|---|---|
| Treatment A-B | Experimental | Patient is treated with 1 hour SPN-CPAP/PS followed by 1 hour of Variable-PS ventilation mode Receives: Procedure: Variable-PS; Procedure: SPN-CPAP/PS |
| Treatment B-A | Experimental | Patient is treated with 1 hour Variable-PS followed by 1 hour of SPN-CPAP/PS ventilation mode Receives: Procedure: SPN-CPAP/PS; Procedure: Variable-PS |
What is being measured
The primary outcome is the main question the study is designed to answer.
HF components
High frequency (HF) components of heartrate-variability in ms²
Measured: 2 hours
Secondary outcomes (3)
SDNN
Standard deviation of normal to normal (SDNN) of heartrate-variability in ms
Measured: 2 hours
HF-LF-ratio
high frequency (HF) to low frequency (LF) ratio of heartrate-variability in 1/s
Measured: 2 hours
Tidal volumes
Changes in mean applicated tidal volumes in ml
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2017
- Study start6 Feb 2018
- Primary completion1 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Ventilation ComplicationStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Vienna University of Technology
- Responsible party
- Principal investigator, Maximilian Schnetzinger BSc, Medical University of Vienna
- Investigators
- Maximlian Schnetzinger, BSc, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03360968
- Sponsor's protocol ID
- EK Nr: 1827/2017
- Status last verified
- Apr 2020
- First submitted
- 22 Nov 2017
- Last updated
- 8 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heartrate Variability During Conventional and Variable Pressure Support Mechanical Ventilation: a Cross-over Study
- ClinicalTrials.gov ID
- NCT03360968
- Acronym / sponsor ID
- EK Nr: 1827/2017
- Conditions
- Mechanical Ventilation Complication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- Vienna University of Technology
- Study start
- 6 Feb 2018 (actual)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 4 Dec 2017 (actual)
- 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.
Rationale Studies show that about a third of all postoperative complications are due to cardiovascular reasons. Furthermore it was shown that more than 50% of postoperative deaths are associated with severe cardiovascular incidents. After surgical interventions seriously ill patients are transferred to intensive care units and mechanically ventilated. However there is not much evidence about the impact of mechanical ventilation on the cardiovascular system and cardiovascular complications. Artificial mechanical ventilation greatly differs from physiological breathing. In contrast to physiological negative pressure ventilation of th lung, mechanical positive pressure ventilation can cause ventilator induced lung injuries. Furthermore a significant deterioration of lung-heart-interaction during mechanical ventilation is known.
Relevance Mechanical ventilation leads to a decreased heartrate-variability, which has to be understood as increased stress on the cardiovascular system. Recently, a new ventilation mode called "variable pressure support ventilation" (VPSV) also known as "noisy pressure support ventilation". This new ventilation mode is similar to the ventilator mode "spontaneous-continuous positive airway pressure/pressure support" (SPN-CPAP), which is often used in a intensive care unit routine. Though VPSV differs through varying applicated pressure support and therefore tidal volumes. Therefore the new ventilation mode rather imitates physiological situation, since tidal volumes vary in physiological breathing, which has positive impact on heart-lung-interaction.
Detailed description
Spontaneous-continuous positive airway pressure support (SPN-CPAP/PS) is the routine ventilator mode used in critically ill patients submitted to an intensive care unit (ICU). It guarantees a positive end expiratory pressure, which prevents atelectasis and minimizes weaning time, by supporting the patient's respiratory drive.
A few years ago, this very established ventilation technique was modified by simply altering the rhythm and volume of gas application: instead of administering same tidal volumes in equal time intervals a variation of applied volume as well as altering frequency in ventilation is introduced. This ventilation method is termed noisy pressure support ventilation (noisy PSV) or variable pressure support ventilation (variable PSV). The variation of pressure support will be within a range around a mean support-pressure (Psupp) and won't exceed a maximum pressure (Pmax), which are both adjusted before starting noisy PSV.
Any variation of breathing is physiological and may occur during speaking, moving and many other factors. As novel concept, the investigator proposes that such variation of ventilation rhythm and volume may have an important impact on heart rate variability (HRV), which is known as to be an indicator of a healthy heart. Since it has been observed that HRV is an important predictor of mortality in coronary care units, investigation of HRV became more important. Recently it was found that low HRV is associated with an increasing mortality and proposed low HRV to be a marker for critical illness.
The analysis and further investigation of HRV has therefore become an important issue in modern medicine. Mechanical ventilation plays a pivotal role in ICUs and should be further improved. Mechanical ventilation per se is stressful for the cardiovascular system. Cardiovascular homeostasis is of major importance and the investigator hypothesises that noisy PSV will decrease the stress applied to the human heart measured via heart rate variability.
In this interventional clinical study, the investigator will apply, in a randomized fashion, conventional PSV and variable PSV each for a duration of one hour. During ventilation the investigator will record all data of the patients monitor, including the electrocardiogram (ECG), which is routinely monitored in patients, and respiratory data, to determine HRV parameters retrospectively. All other ventilatory, hemodynamic and pharmacological treatment will be part of the clinical routine. As two modes of ventilation will be compared, this study is an interventional clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A-B | Experimental | Procedure: Variable-PS, Procedure: SPN-CPAP/PSPatient is treated with 1 hour SPN-CPAP/PS followed by 1 hour of Variable-PS ventilation mode |
| Treatment B-A | Experimental | Procedure: SPN-CPAP/PS, Procedure: Variable-PSPatient is treated with 1 hour Variable-PS followed by 1 hour of SPN-CPAP/PS ventilation mode |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing therapy at an ICU; patients intubated and ventilated using SPN-CPAP/PS ventilator mode; patients with sinus rhythm in electrocardiogram
Key exclusion criteria (1 listed)
- patients with active heart pace maker / defibrillator; patients with absent sinus rhythm in electrocardiogram; patients with known severe disease of autonomous nervous system
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 |
|---|---|---|
| Variable-PSVariable-PS mode switched on for 1 hour | Procedure or surgery | Treatment A-B |
| SPN-CPAP/PSSPN-CPAP/PS mode switched on for 1 hour | Procedure or surgery | Treatment A-B, Treatment B-A |
| Variable-PSVariable-PS mode switched on for 1 hour | Procedure or surgery | Treatment B-A |
Primary outcome
HF components
Time frame: 2 hours
High frequency (HF) components of heartrate-variability in ms²
3 secondary outcomes
SDNN
Time frame: 2 hours
HF-LF-ratio
Time frame: 2 hours
Tidal volumes
Time frame: 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2020.
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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.
Maximlian Schnetzinger, BSc principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Variable-PS and SPN-CPAP/PS in people with Mechanical Ventilation Complication, run by Medical University of Vienna at 1 site in Austria.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 8 Apr 2020. 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 Austria. 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?
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?
HF components (time frame: 2 hours). 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 8 Apr 2020.