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Not yet recruitingNCT06298435OPTIMVSPRIMEUpdated Mar 7, 2024

Optimising Ventilatory Strategies by Using Positive Respiratory Integer Measurements

An observational study in Hypoxemia, Hypercapnia and Ventilator Associated Pneumonia, sponsored by University Medical Center Groningen. Not yet recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-07.

Sponsored by University Medical Center Groningen · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 7 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
20,000
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 28 studies in Hypoxia with a site in Netherlands — 2 open to participants now, 2 under way, 1 of them phase 3. Hypoxia · Netherlands.

Started
2024
the only one that year
Observational
6 of 28
1 open now
Registered
28th of 28
by date
Lead sponsor
3 of 28
University Medical Center Groningen

Among the 28 studies in Hypoxia with a site in Netherlands, this one is the only one that started in 2024, is one of 6 observational ones, and was the 28th registered.

By phase

28 studies; the count open now beside each. This study's row is marked.

No phase12 · 0 open
Observationalthis study6 · 1 open
Phase 25 · 0 open
Phase 1/22 · 0 open
Phase 11 · 0 open
Phase 31 · 1 open
Phase 41 · 0 open

By the year they started

First in 2005; this study’s year is marked. 1 started in 2024.

Size and results

Median enrollment 30 across the 22 interventional studies, 111 across the 6 observational. Of the 21 that completed or were terminated, 1 (5%) have results posted.

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02

Study 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. 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

03

Conditions studied

  • Hypoxemia
  • Hypercapnia
  • Ventilator Associated Pneumonia
  • Complication of Anesthesia
  • Postoperative Complications
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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 criteria

  • 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
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
20,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • GA group

    Adult patients having undergone surgery under general anesthesia with IPPV in the UMCG between 01-01-2018 and 01-04-2023

    Procedure: Intermittent Positive pressure ventilation

Interventions

  • ProcedureIntermittent Positive pressure ventilation

    Intermittent positive pressure ventilation during general anesthesia for non-cardiac surgery

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Mar 2024; primary completion for Apr 2025, 13 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 12, 2024
First posted
Mar 7, 2024
StartEst.
Mar 1, 2024
Primary completionEst.
Apr 1, 2025
CompletionEst.
Apr 1, 2025
Last update
Mar 7, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06298435
Responsible party
Sponsor
First posted
Mar 7, 2024
Start date
Mar 1, 2024 (estimated)
Primary completion
Apr 1, 2025 (estimated)
Completion
Apr 1, 2025 (estimated)
Last update
Mar 7, 2024

Study contacts

Clemens Barends, phd
Contact
c.r.m.barends@umcg.nl
+31-503616161
Clemens Barends, phd
principal investigator · UMCG

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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