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

NCT05831683 | Completed

• 1 other identifier: SOP LPV study
• Study Type: observational
• Target: 164
• Locations: 1 country
• Sites: 1

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.

Conditions

Adherence, Treatment

Keywords

Lung Protective Ventilation; Ventilation; Standard Operating Procedure; Adherence; Mechanical Ventilation

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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.

  From initiation of mechanical ventilation till extubation, assessed up to 8 hours.

• SOP increase the number of cases with PEEP greater than six cmH2O

  From initiation of mechanical ventilation till extubation, assessed up to 8 hours.

Study Arms (2)

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.

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

Interventions

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.

Group B - After SOP introduction

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

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

Ústí nad Labem, Ústí Nad Labem Region, 40001, Czechia

Location

Related Publications (1)

• 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.

  PMID: 41039371 DERIVED

MeSH Terms

Conditions

Treatment Adherence and Compliance; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michal Kalina, MUDr.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: April 26, 2023
• Study Start: April 20, 2023
• Primary Completion: June 11, 2023
• Study Completion: June 18, 2023
• Last Updated: February 5, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)