HypoxemiaOPTIMVSPRIMENCT06298435
Optimising Ventilatory Strategies by Using Positive Respiratory Integer Measurements
An observational study of Hypoxemia and Hypercapnia, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
Background Intermittent Positive Pressure Ventilation is used during general anesthesia but can lead to serious complications. Respiratory parameter settings can be adjusted to minimize the detrimental effects of this unphysiological artificial respiration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoxemia, Hypercapnia, Ventilator Associated Pneumonia
- What is being tested?
- Intermittent Positive pressure ventilation
- Type of treatment
- Surgery or procedure
- How many people
- 20,000 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Mar 2024to 1 Apr 2025
- Phase
- Observational
- 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
Study population: Inclusion criteria: Adult patients having undergone surgery under general anesthesia with IPPV in the UMCG between 01-01-2018 and 01-04-2023. •
- Inclusion criteria: Adult patients having undergone surgery under general anesthesia with Intermittent Positive Pressure Ventilation in the UMCG between 01-01-2018 and 01-04-2023.
- Exclusion criteria: age <18 years; no use ofIntermittent Positive Pressure Ventilation; not under general anesthesia
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
UMCG
Groningen, 9700RB
Rob Spanjersberg, +31503616161, r.spanjersberg@umcg.nl
About this study
- Background Intermittent Positive Pressure Ventilation is used during general anesthesia but can lead to serious complications. Respiratory parameter settings can be adjusted to minimize the detrimental effects of this unphysiological artificial respiration. Determining optimal ventilator settings is a multifactorial problem with many possible realisations. Knowledge of the relationship of patient outcomes with mathematically identifiable integer sets of ventilator setting parameters may help to understand which effects ventilator settings have on patient outcomes. An exploratory database study can provide a basis for further, prospective, interventional studies to find the optimal combination of ventilator settings.
Main research question
- To determine the relationship between the use of mathematically identifiable integer ventilator parameter sets and patient outcomes
- Design (including population, confounders/outcomes) Retrospective database study of all cases of adult patients undergoing procedures in the UMCG under general anesthesia with IPPV between 01-01-2018 and 01-04-2023. Multivariate and mixed-model analyses, where appropriate, will be corrections for patient specific characteristics such as ASA PS, age, BMI, sex.
- Expected results Using mathematically identifiable integer ventilatory parameter sets improves respiratory and/or hemodynamic patient outcomes.
Read the detailed description
- Introduction and rationale
Intermittent Positive Pressure Ventilation (IPPV) is required for almost every patient under general anesthesia. It is recognized that IPPV is an unphysiological way of breathing and it can have serious complications when instituted incorrectly. 1 Known complications of IPPV include (but are not limited to) desaturation, atelectasis and baro-/volutrauma.
Many studies have tried to determine the optimal settings for ventilatory parameters during IPPV. 2 Currently, however, it is unknown whether the use of specific ventilatory parameter sets is related to improved outcomes for patients undergoing procedures under general anesthesia.
IPPV is commonly instituted using a set of parameters which determine respiratory characteristics among which are Peak Inspiratory Pressure (PIP), Positive End Expiratory Pressure (PEEP), Plateau Pressure (PlatP) and the Fraction of Inspired Oxygen(FiO2). 3 Adjustment of these parameters allows the clinician to optimize the mechanical characteristics of the artificial respiration of the patient.
IPPV changes intrathoracic pressure in a cyclic way. Pressure increases during inspiration and decreases during expiration. The influence of increased intrathoracic pressure, caused by IPPV, on hemodynamic parameters is well known and is one of the factors used by anesthesiologists when instituting IPPV. IPPV-pressures may both increase or decrease hemodynamic parameters such as cardiac preload and left ventricular wall tension, thus influencing not only oxygenation and decarbonization, but also cardiac output, myocardial oxygen consumption and direct cerebral oxygenation. The relationship between respiration and circulation exhibits complex dynamics and understanding this may help to promote more natural and physiologic breathing patterns, leading to improved oxygenation and reduced respiratory distress.
In addition to direct influence of positive ventilatory pressures on hemodynamic factors the cyclic nature of both IPPV and hemodynamic factors needs to be taken into account when investigating the relationship between IPPV and patient outcomes. When changes in respiratory pressures coincide with related physiological phenomena, each cycle may pose an additive influence on both parameters. Furthermore, coinciding physiological cycles may lead to "respiratory entrainment," where the ventilator-induced breaths becomes asynchronizous with the patient's intrinsic respiratory rhythm, leading to ineffective ventilation and increased risk of lung injury. Additionally, reducing respiratory entrainment may help to reduce the likelihood of mechanical fatigue and stress on the lung tissue, as it avoids repetitive or periodic stress on the respiratory system. Using mathematically identified integer sets as ventilatory parameter settings may reduce the coinciding of respiratory cycles with recurring physiological phenomena. Furthermore, the role of mathematical identification of optimal integer sets for use in ventilator parameters can help find optimal settings to reduce complications from Intermittent Positive Pressure Ventilation
Research question To determine the relationship between the use of mathematically identifiable integer ventilator parameter sets and patient outcomes
METHOD Description study design
This is a retrospective database study. A database search of all cases of adult patients undergoing procedures in the UMCG under general anesthesia with IPPV between 01-01-2018 and 01-04-2023 will be conducted. Researchers will use anonymized data only from the existing patient data records.
This study will investigate the relationship of mathematically identifiable integer sets of ventilator setting parameters during surgery performed under general anesthesia with IPPV. Data will be extracted from the Electronic Patient Database and all data will be handled anonymously.
Parameter integer sets will be identified using probabilistic (or Monte Carlo) algorithms and sieve methods. Non-multifactorial and multifactorial sets will be compared and only non-negative integers will be considered for analysis
Univariate, multivariate regression methods and mixed-model analyses, where appropriate, will be used to determine which integer sets in ventilatory parameter settings during surgery performed under general anesthesia and IPPV are related to patient outcomes such as SpO2 and FiO2/ SpO2-ratio
- Conditions
- Hypoxemia, Hypercapnia, Ventilator Associated Pneumonia, Complication of Anesthesia, Postoperative Complications
- Being tested
- Intermittent Positive pressure ventilation
- Medical subject headings
- Hypoxia, Hypercapnia, Pneumonia, Ventilator-Associated, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent Positive pressure ventilationProcedure or surgery
Intermittent positive pressure ventilation during general anesthesia for non-cardiac surgery
| Study group | Role | What they receive |
|---|---|---|
| GA group | Adult patients having undergone surgery under general anesthesia with IPPV in the UMCG between 01-01-2018 and 01-04-2023 Receives: Procedure: Intermittent Positive pressure ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
SpO2/FiO2 ratio
Measured: from start of intermittent positive pressure ventilation until end of intermittent positive pressure ventilation, assessed for a maximum of 24 hours after start of Intermittent Positive Pressure Ventilation
SpO2
Measured: from start of intermittent positive pressure ventilation until end of intermittent positive pressure ventilation, assessed for a maximum of 24 hours after start of Intermittent Positive Pressure Ventilation
etCO2
Measured: from start of intermittent positive pressure ventilation until end of intermittent positive pressure ventilation, assessed for a maximum of 24 hours after start of Intermittent Positive Pressure Ventilation
Blood Pressure
Measured: from start of intermittent positive pressure ventilation until end of intermittent positive pressure ventilation, assessed for a maximum of 24 hours after start of Intermittent Positive Pressure Ventilation
Heart Rate
Measured: from start of intermittent positive pressure ventilation until end of intermittent positive pressure ventilation, assessed for a maximum of 24 hours after start of Intermittent Positive Pressure Ventilation
Positive end Expiratory Pressure
Measured: from start of intermittent positive pressure ventilation until end of intermittent positive pressure ventilation, assessed for a maximum of 24 hours after start of Intermittent Positive Pressure Ventilation
Plateau Pressure
Measured: from start of intermittent positive pressure ventilation until end of intermittent positive pressure ventilation, assessed for a maximum of 24 hours after start of Intermittent Positive Pressure Ventilation
Respiration rate
Measured: from start of intermittent positive pressure ventilation until end of intermittent positive pressure ventilation, assessed for a maximum of 24 hours after start of Intermittent Positive Pressure Ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start1 Mar 2024 (estimated)
- Primary completion1 Apr 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxemiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clemens Barends, phd, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06298435
- Sponsor's protocol ID
- 17536
- Acronym
- OPTIMVSPRIME
- Status last verified
- Feb 2024
- First submitted
- 12 Feb 2024
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimising Ventilatory Strategies by Using Positive Respiratory Integer Measurements
- ClinicalTrials.gov ID
- NCT06298435
- Acronym / sponsor ID
- OPTIMVSPRIME / 17536
- Conditions
- Hypoxemia, Hypercapnia, Ventilator Associated Pneumonia, Complication of Anesthesia, Postoperative Complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Apr 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 7 Mar 2024 (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.
- Background Intermittent Positive Pressure Ventilation is used during general anesthesia but can lead to serious complications. Respiratory parameter settings can be adjusted to minimize the detrimental effects of this unphysiological artificial respiration. Determining optimal ventilator settings is a multifactorial problem with many possible realisations. Knowledge of the relationship of patient outcomes with mathematically identifiable integer sets of ventilator setting parameters may help to understand which effects ventilator settings have on patient outcomes. An exploratory database study can provide a basis for further, prospective, interventional studies to find the optimal combination of ventilator settings.
Main research question
- To determine the relationship between the use of mathematically identifiable integer ventilator parameter sets and patient outcomes
- Design (including population, confounders/outcomes) Retrospective database study of all cases of adult patients undergoing procedures in the UMCG under general anesthesia with IPPV between 01-01-2018 and 01-04-2023. Multivariate and mixed-model analyses, where appropriate, will be corrections for patient specific characteristics such as ASA PS, age, BMI, sex.
- Expected results Using mathematically identifiable integer ventilatory parameter sets improves respiratory and/or hemodynamic patient outcomes.
Detailed description
- Introduction and rationale
Intermittent Positive Pressure Ventilation (IPPV) is required for almost every patient under general anesthesia. It is recognized that IPPV is an unphysiological way of breathing and it can have serious complications when instituted incorrectly. 1 Known complications of IPPV include (but are not limited to) desaturation, atelectasis and baro-/volutrauma.
Many studies have tried to determine the optimal settings for ventilatory parameters during IPPV. 2 Currently, however, it is unknown whether the use of specific ventilatory parameter sets is related to improved outcomes for patients undergoing procedures under general anesthesia.
IPPV is commonly instituted using a set of parameters which determine respiratory characteristics among which are Peak Inspiratory Pressure (PIP), Positive End Expiratory Pressure (PEEP), Plateau Pressure (PlatP) and the Fraction of Inspired Oxygen(FiO2). 3 Adjustment of these parameters allows the clinician to optimize the mechanical characteristics of the artificial respiration of the patient.
IPPV changes intrathoracic pressure in a cyclic way. Pressure increases during inspiration and decreases during expiration. The influence of increased intrathoracic pressure, caused by IPPV, on hemodynamic parameters is well known and is one of the factors used by anesthesiologists when instituting IPPV. IPPV-pressures may both increase or decrease hemodynamic parameters such as cardiac preload and left ventricular wall tension, thus influencing not only oxygenation and decarbonization, but also cardiac output, myocardial oxygen consumption and direct cerebral oxygenation. The relationship between respiration and circulation exhibits complex dynamics and understanding this may help to promote more natural and physiologic breathing patterns, leading to improved oxygenation and reduced respiratory distress.
In addition to direct influence of positive ventilatory pressures on hemodynamic factors the cyclic nature of both IPPV and hemodynamic factors needs to be taken into account when investigating the relationship between IPPV and patient outcomes. When changes in respiratory pressures coincide with related physiological phenomena, each cycle may pose an additive influence on both parameters. Furthermore, coinciding physiological cycles may lead to "respiratory entrainment," where the ventilator-induced breaths becomes asynchronizous with the patient's intrinsic respiratory rhythm, leading to ineffective ventilation and increased risk of lung injury. Additionally, reducing respiratory entrainment may help to reduce the likelihood of mechanical fatigue and stress on the lung tissue, as it avoids repetitive or periodic stress on the respiratory system. Using mathematically identified integer sets as ventilatory parameter settings may reduce the coinciding of respiratory cycles with recurring physiological phenomena. Furthermore, the role of mathematical identification of optimal integer sets for use in ventilator parameters can help find optimal settings to reduce complications from Intermittent Positive Pressure Ventilation
Research question To determine the relationship between the use of mathematically identifiable integer ventilator parameter sets and patient outcomes
METHOD Description study design
This is a retrospective database study. A database search of all cases of adult patients undergoing procedures in the UMCG under general anesthesia with IPPV between 01-01-2018 and 01-04-2023 will be conducted. Researchers will use anonymized data only from the existing patient data records.
This study will investigate the relationship of mathematically identifiable integer sets of ventilator setting parameters during surgery performed under general anesthesia with IPPV. Data will be extracted from the Electronic Patient Database and all data will be handled anonymously.
Parameter integer sets will be identified using probabilistic (or Monte Carlo) algorithms and sieve methods. Non-multifactorial and multifactorial sets will be compared and only non-negative integers will be considered for analysis
Univariate, multivariate regression methods and mixed-model analyses, where appropriate, will be used to determine which integer sets in ventilatory parameter settings during surgery performed under general anesthesia and IPPV are related to patient outcomes such as SpO2 and FiO2/ SpO2-ratio
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GA group | – | Procedure: Intermittent Positive pressure ventilationAdult patients having undergone surgery under general anesthesia with IPPV in the UMCG between 01-01-2018 and 01-04-2023 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inclusion criteria: Adult patients having undergone surgery under general anesthesia with IPPV in the UMCG between 01-01-2018 and 01-04-2023. •
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 |
|---|---|---|
| Intermittent Positive pressure ventilationIntermittent positive pressure ventilation during general anesthesia for non-cardiac surgery | Procedure or surgery | GA group |
Primary outcome
SpO2/FiO2 ratio
Time frame: from start of intermittent positive pressure ventilation until end of intermittent positive pressure ventilation, assessed for a maximum of 24 hours after start of Intermittent Positive Pressure Ventilation
SpO2
Time frame: from start of intermittent positive pressure ventilation until end of intermittent positive pressure ventilation, assessed for a maximum of 24 hours after start of Intermittent Positive Pressure Ventilation
etCO2
Time frame: from start of intermittent positive pressure ventilation until end of intermittent positive pressure ventilation, assessed for a maximum of 24 hours after start of Intermittent Positive Pressure Ventilation
Blood Pressure
Time frame: from start of intermittent positive pressure ventilation until end of intermittent positive pressure ventilation, assessed for a maximum of 24 hours after start of Intermittent Positive Pressure Ventilation
Heart Rate
Time frame: from start of intermittent positive pressure ventilation until end of intermittent positive pressure ventilation, assessed for a maximum of 24 hours after start of Intermittent Positive Pressure Ventilation
Positive end Expiratory Pressure
Time frame: from start of intermittent positive pressure ventilation until end of intermittent positive pressure ventilation, assessed for a maximum of 24 hours after start of Intermittent Positive Pressure Ventilation
Plateau Pressure
Time frame: from start of intermittent positive pressure ventilation until end of intermittent positive pressure ventilation, assessed for a maximum of 24 hours after start of Intermittent Positive Pressure Ventilation
Respiration rate
Time frame: from start of intermittent positive pressure ventilation until end of intermittent positive pressure ventilation, assessed for a maximum of 24 hours after start of Intermittent Positive Pressure Ventilation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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.
Clemens Barends, phd principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoxemia and Hypercapnia, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 7 Mar 2024. 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 Netherlands. 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?
Contact Clemens Barends, phd (+31-503616161, c.r.m.barends@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SpO2/FiO2 ratio (time frame: from start of intermittent positive pressure ventilation until end of intermittent positive pressure ventilation, assessed for a maximum of 24 hours after start of Intermittent Positive Pressure Ventilation). The study lists 8 primary outcomes in all. 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 7 Mar 2024; AzTrials last refreshed its copy on 26 Oct 2026.