Adherence, TreatmentNCT05831683
Standard Operating Procedure As a Valuable Tool to Increase Adherence to Lung Protective Ventilation Among Anesthesiologists.
An observational study of Adherence, Treatment, run by Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s. at 1 site in Czechia.
Trial summary
Lung Protective Ventilation (LPV) is considered the gold standard of care nowadays. Even though, all over the world reported adherence to this concept, among anesthesiologists, is only 15%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adherence, Treatment
- What is being tested?
- Introduction of Standard Operating Procedure regarding lung protective ventilation during general anaesthesia.
- How many people
- 164 participants
- Where
- 1 siteCzechia
- Study dates
- 20 Apr 2023to 18 Jun 2023
- 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: Ventilatory parameters will be recorded during a case of general anesthesia with the use of an endotracheal tube and a time-cycled ventilatory regime. The recording will be from adult-only operating theatres.
Who may be able to join
- A general anaesthesia case with the airway secured with the endotracheal tube
Who cannot join
- General anaesthesia without time cycled ventilator regime
- General anaesthesia without airway secured with an endotracheal tube
- General anaesthesia in which the care is given by a member of the study team of this study
- General anaesthesia in which one lung ventilation is used
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Masarykova Nemocnice v Ústí nad Labem, Krajská Zdravotní a.s.
Ústí nad Labem, Ústí nad Labem Region, 40001
About this study
Lung Protective Ventilation (LPV) is considered the gold standard of care nowadays. Even though, all over the world reported adherence to this concept, among anesthesiologists, is only 15%. The investigators hypothesized that the introduction of the Standard Operating Procedure (SOP) document will increase adherence to LPV among anesthesiologists. In this study, the investigators will record ventilating parameters during general anesthesia using Care Station Insights software. Then, the investigators will evaluate the recorded parameters and match them with LPV criteria. The adherence level to every parameter separately will be counted in percentage.
Read the detailed description
In this study, the investigators will start by stating the current adherence level to the LPV concept during general anesthesia among anesthesiologists. Adherence will be calculated as percentage of cases that will met the criteria. The evaluation will be based on saved data in Care Station Insights software from General Electric. This software is running on anesthesia machines GE Aysis CS2.
The investigators will record and evaluate:
- Positive End Expiratory Pressure (PEEP) [cmH2O]
- Plateau Pressure (Pplat) [cmH2O]
- driving pressure [cmH2O]
- Tidal Volume/Ideal Body Weight (VT/IBW)
- number of recruitment maneuvers during a case
- phase of a case when recruitment maneuver is done (induction/maintenance/emergence)
Each parameter will be evaluated separately. The adherence level for each parameter will be interpreted as a percentage of cases that meet the LPV criteria in terms of the given parameter. The investigators will evaluate the 100 most recent cases, before the SOP introduction, to state the current adherence level.
After stating the current adherence level to the LPV during general anesthesia, the investigators will introduce the Standard Operating Procedure document (SOP). SOP introduction will be supplemented with an educational program regarding LPV.
The SOP will include:
- the definition of LPV
- the theoretical background of LPV
- LPV strategy recommendations/criteria
The educational program:
- set of 11 half-hour-long sessions with LPV experts
- induction recommendations
- preoxygenation recommendations
- PEEP intraoperative recommendations
- LPV strategy during general anaesthesia and perioperative complications
- LPV in specific situations
- laparoscopy
- robotics surgery
- pronation
- recruitment maneuvers during general anaesthesia
- extubation recommendations
- neuromuscular blockade and monitoring recommendations
- Adequacy of Anaesthesia (AoA) strategy
Then, the investigators will begin with recording the second set of ventilatory parameters. The investigators will collect the very same parameters to state the current adherence level to LPV during general anesthesia as in the first data set. Ventilatory parameters will be collected the same way as for the first data set, with the use of Care Station Insights software. Anesthesiologists giving the anesthesia care will not know neither the goal of the study nor which parameters are recorded.
After finishing collecting the second data set, based on sample size calculation, the investigators will evaluate these. The evaluation process will be identical to the evaluation process of stating the current adherence level. The investigators will evaluate each parameter separately. Adherence for each parameter will be interpreted as a percentage of cases that meet the LPV criteria in terms of the given parameter.
At the finish, the investigators will compare adherence levels before and after the SOP introduction.
- Conditions
- Adherence, Treatment
- Being tested
- Introduction of Standard Operating Procedure regarding lung protective ventilation during general anaesthesia.
- Keywords
- Lung Protective Ventilation, Ventilation, Standard Operating Procedure, Adherence, Mechanical Ventilation
- Medical subject headings
- Treatment Adherence and Compliance, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Introduction of Standard Operating Procedure regarding lung protective ventilation during general anaesthesia.Other
The Standard Operating Procedure document will be introduced. The SOP document will cover the theoretical background, definition, and recommendations/criteria of LPV. The SOP document will reflect the most recent LPV guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Group A - Current state | In this group, ventilator parameters will be recorded before the SOP introduction. We will analyze PEEP, Pplat, driving pressure, VT/IBW, and the number and phase of recruitment maneuvers during general anesthesia. | |
| Group B - After SOP introduction | In this group, ventilator parameters will be collected after the SOP introduction. We will analyze PEEP, Pplat, driving pressure, VT/IBW, and the number and phase of recruitment maneuvers during general anesthesia. Receives: Other: Introduction of Standard Operating Procedure regarding lung protective ventilation during general anaesthesia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
SOP increase adherence level to lung protective ventilation strategy
The primary objective of the study is to demonstrate that the introduction of the SOP document regarding LPV during general anesthesia will increase adherence (number of cases that meet the SOP criteria) to the LPV concept during general anesthesia among anesthesiologists. We will collect ventilatory parameters during general anesthesia. These parameters will be then evaluated against LPV recommendations. The level of adherence will be counted as a percentage of cases that meets the LPV criteria. For each parameter, we will count the level of adherence separately.
Measured: From initiation of mechanical ventilation till extubation, assessed up to 8 hours.
Secondary outcomes (3)
SOP increase the total number of recruitment maneuvers during a case
The secondary aim of this study is to demonstrate that the introduction of the SOP document regarding LPV during general anesthesia will increase the total number of recruitment maneuvers. With the use of Care Station Insights software, we will record how many recruitment maneuvers are done during general anesthesia. We will compare the total number in the first data set (before the SOP introduction) and in the second data set (after the SOP introduction).
Measured: From initiation of mechanical ventilation till extubation, assessed up to 8 hours.
SOP increase the total number of recruitment maneuvers within the first ten minutes in a case.
The secondary aim of this study is to demonstrate that the introduction of the SOP document regarding LPV during general anesthesia will increase the total number of recruitment maneuvers that are performed within the first ten minutes after securing the airway. We will count the number of recruitment maneuvers done within the first ten minutes and we will compare the count in the first data set (before the SOP introduction) and in the second data set (after the SOP introduction).
Measured: From initiation of mechanical ventilation till extubation, assessed up to 8 hours.
SOP increase the number of cases with PEEP greater than six cmH2O
The secondary aim of this study is to demonstrate that the introduction of the SOP document regarding LPV during general anesthesia will result in a statistically significant increase in cases with a PEEP value greater than eight cmH2O. We will record the PEEP during a case. For evaluation, we will use the average value of PEEP during the case. We will compare the average PEEP in the first data set (before the SOP introduction) and in the second data set (after the SOP introduction).
Measured: From initiation of mechanical ventilation till extubation, assessed up to 8 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start20 Apr 2023
- Primary completion11 Jun 2023
- Study completion18 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adherence, TreatmentStudies 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
- Prospective
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michal Kalina, Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
- Investigators
- Michal Kalina, MUDr., Principal investigator, Krajská Zdravotní a.s. Klinika anesteziologie, perioperační a intenzivní medicíny MNUL a FZS UJEP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05831683
- Sponsor's protocol ID
- SOP LPV study
- Status last verified
- Aug 2024
- First submitted
- 3 Apr 2023
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Michal K, Jan B, Josef S, Patricia V, Adela B, Roman S, Vladimir C. The mandatory educational module increases the effect of implementing the standard operating procedure and adherence to the lung-protective ventilation concept during anaesthesia. BMC Med Educ. 2025 Oct 2;25(1):1333. doi: 10.1186/s12909-025-07923-z.
PubMed 41039371
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard Operating Procedure As a Valuable Tool to Increase Adherence to Lung Protective Ventilation Among Anesthesiologists.
- ClinicalTrials.gov ID
- NCT05831683
- Acronym / sponsor ID
- SOP LPV study
- Conditions
- Adherence, Treatment
- Keywords
- Lung Protective Ventilation, Ventilation, Standard Operating Procedure, Adherence, Mechanical Ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.University, hospital or other
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 11 Jun 2023 (actual)
- Study completion
- 18 Jun 2023 (actual)
- First posted
- 26 Apr 2023 (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.
Lung Protective Ventilation (LPV) is considered the gold standard of care nowadays. Even though, all over the world reported adherence to this concept, among anesthesiologists, is only 15%. The investigators hypothesized that the introduction of the Standard Operating Procedure (SOP) document will increase adherence to LPV among anesthesiologists. In this study, the investigators will record ventilating parameters during general anesthesia using Care Station Insights software. Then, the investigators will evaluate the recorded parameters and match them with LPV criteria. The adherence level to every parameter separately will be counted in percentage.
Detailed description
In this study, the investigators will start by stating the current adherence level to the LPV concept during general anesthesia among anesthesiologists. Adherence will be calculated as percentage of cases that will met the criteria. The evaluation will be based on saved data in Care Station Insights software from General Electric. This software is running on anesthesia machines GE Aysis CS2.
The investigators will record and evaluate:
- Positive End Expiratory Pressure (PEEP) [cmH2O]
- Plateau Pressure (Pplat) [cmH2O]
- driving pressure [cmH2O]
- Tidal Volume/Ideal Body Weight (VT/IBW)
- number of recruitment maneuvers during a case
- phase of a case when recruitment maneuver is done (induction/maintenance/emergence)
Each parameter will be evaluated separately. The adherence level for each parameter will be interpreted as a percentage of cases that meet the LPV criteria in terms of the given parameter. The investigators will evaluate the 100 most recent cases, before the SOP introduction, to state the current adherence level.
After stating the current adherence level to the LPV during general anesthesia, the investigators will introduce the Standard Operating Procedure document (SOP). SOP introduction will be supplemented with an educational program regarding LPV.
The SOP will include:
- the definition of LPV
- the theoretical background of LPV
- LPV strategy recommendations/criteria
The educational program:
- set of 11 half-hour-long sessions with LPV experts
- induction recommendations
- preoxygenation recommendations
- PEEP intraoperative recommendations
- LPV strategy during general anaesthesia and perioperative complications
- LPV in specific situations
- laparoscopy
- robotics surgery
- pronation
- recruitment maneuvers during general anaesthesia
- extubation recommendations
- neuromuscular blockade and monitoring recommendations
- Adequacy of Anaesthesia (AoA) strategy
Then, the investigators will begin with recording the second set of ventilatory parameters. The investigators will collect the very same parameters to state the current adherence level to LPV during general anesthesia as in the first data set. Ventilatory parameters will be collected the same way as for the first data set, with the use of Care Station Insights software. Anesthesiologists giving the anesthesia care will not know neither the goal of the study nor which parameters are recorded.
After finishing collecting the second data set, based on sample size calculation, the investigators will evaluate these. The evaluation process will be identical to the evaluation process of stating the current adherence level. The investigators will evaluate each parameter separately. Adherence for each parameter will be interpreted as a percentage of cases that meet the LPV criteria in terms of the given parameter.
At the finish, the investigators will compare adherence levels before and after the SOP introduction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A - Current state | – | –In this group, ventilator parameters will be recorded before the SOP introduction. We will analyze PEEP, Pplat, driving pressure, VT/IBW, and the number and phase of recruitment maneuvers during general anesthesia. |
| Group B - After SOP introduction | – | Other: Introduction of Standard Operating Procedure regarding lung protective ventilation during general anaesthesia.In this group, ventilator parameters will be collected after the SOP introduction. We will analyze PEEP, Pplat, driving pressure, VT/IBW, and the number and phase of recruitment maneuvers during general anesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ventilatory parameters will be recorded during a case of general anesthesia with the use of an endotracheal tube and a time-cycled ventilatory regime. The recording will be from adult-only operating theatres.
Key inclusion criteria (1 listed)
- A general anaesthesia case with the airway secured with the endotracheal tube
Key exclusion criteria (4 listed)
- General anaesthesia without time cycled ventilator regime
- General anaesthesia without airway secured with an endotracheal tube
- General anaesthesia in which the care is given by a member of the study team of this study
- General anaesthesia in which one lung ventilation is used
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 |
|---|---|---|
| Introduction of Standard Operating Procedure regarding lung protective ventilation during general anaesthesia.The Standard Operating Procedure document will be introduced. The SOP document will cover the theoretical background, definition, and recommendations/criteria of LPV. The SOP document will reflect the most recent LPV guidelines. | Other | Group B - After SOP introduction |
Primary outcome
SOP increase adherence level to lung protective ventilation strategy
Time frame: From initiation of mechanical ventilation till extubation, assessed up to 8 hours.
The primary objective of the study is to demonstrate that the introduction of the SOP document regarding LPV during general anesthesia will increase adherence (number of cases that meet the SOP criteria) to the LPV concept during general anesthesia among anesthesiologists. We will collect ventilatory parameters during general anesthesia. These parameters will be then evaluated against LPV recommendations. The level of adherence will be counted as a percentage of cases that meets the LPV criteria. For each parameter, we will count the level of adherence separately.
3 secondary outcomes
SOP increase the total number of recruitment maneuvers during a case
Time frame: From initiation of mechanical ventilation till extubation, assessed up to 8 hours.
SOP increase the total number of recruitment maneuvers within the first ten minutes in a case.
Time frame: From initiation of mechanical ventilation till extubation, assessed up to 8 hours.
SOP increase the number of cases with PEEP greater than six cmH2O
Time frame: From initiation of mechanical ventilation till extubation, assessed up to 8 hours.
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 5 Feb 2025.
- Derived from this study: PubMed 41039371Michal K, Jan B, Josef S, Patricia V, Adela B, Roman S, Vladimir C. The mandatory educational module increases the effect of implementing the standard operating procedure and adherence to the lung-protective ventilation concept during anaesthesia. BMC Med Educ. 2025 Oct 2;25(1):1333. doi: 10.1186/s12909-025-07923-z.
- Individual participant dataSharing planned: No
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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.
Michal Kalina, MUDr. principal investigator
Krajská Zdravotní a.s. Klinika anesteziologie, perioperační a intenzivní medicíny MNUL a FZS UJEP
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 Adherence, Treatment, run by Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s. at 1 site in Czechia.
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 4 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 5 Feb 2025. 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 Czechia. 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?
SOP increase adherence level to lung protective ventilation strategy (time frame: From initiation of mechanical ventilation till extubation, assessed up to 8 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05831683, which also lists 1 linked publication.
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 5 Feb 2025.