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
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.
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.
1,076 studies on the registry are indexed under Hypoxia; 213 are open to participants now.
This study's planned enrollment of 20,000 is above the median of 79 across 277 observational studies indexed under Hypoxia.
Browse Hypoxia studies →2 of the 28 studies in Hypoxia with a site in Netherlands are open now, in 3 countries. Each count lists the studies.
Of the 125 Hypoxia studies recruiting now, 53 (42%) set no upper age limit and 45 (36%) stop at 75 or younger; 15 take children under 18; 33 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →28 studies; the count open now beside each. This study's row is marked.
First in 2005; this study’s year is marked. 1 started in 2024.
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.
1 of 28 have an industry lead sponsor. The 10 most frequent:
University Medical Center Groningen is the lead sponsor of 627 studies on the registry; 176 are open to participants now.
University Medical Center Groningen has 3 studies filed under Hypoxia — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 28 studies in Hypoxia with a site in Netherlands, from their registry updates:
Nothing recorded among them since 2026-09-25.
Main research question
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
Inclusion criteria: Adult patients having undergone surgery under general anesthesia with IPPV in the UMCG between 01-01-2018 and 01-04-2023.
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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
Intermittent positive pressure ventilation during general anesthesia for non-cardiac surgery
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
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Mar 2024; primary completion for Apr 2025, 13 months later.
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