Standard Operating Procedure As a Valuable Tool to Increase Adherence to Lung Protective Ventilation Among Anesthesiologists.

NCT ID: NCT05831683

Last Updated: 2025-02-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 164 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-20
• Study Completion Date: 2023-06-18

Brief 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%. 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.

Conditions

Adherence, Treatment

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

Introduction of Standard Operating Procedure regarding lung protective ventilation during general anaesthesia.

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• A general anaesthesia case with the airway secured with the endotracheal tube

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.

OTHER

Sponsor Role: lead

Responsible Party

Michal Kalina

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michal Kalina, MUDr.

Role: PRINCIPAL_INVESTIGATOR

Krajská Zdravotní a.s. Klinika anesteziologie, perioperační a intenzivní medicíny MNUL a FZS UJEP

Locations

Masarykova Nemocnice v Ústí nad Labem, Krajská Zdravotní a.s.

Ústí nad Labem, Ústí Nad Labem Region, Czechia

Countries

Czechia

References

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.

Reference Type: DERIVED

PMID: 41039371 (View on PubMed)

Other Identifiers

SOP LPV study

Identifier Type: -

Identifier Source: org_study_id