Optimising Ventilatory Strategies by Using Positive Respiratory Integer Measurements

NCT06298435 | Not Yet Recruiting

• 1 other identifier: 17536
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypoxemia; Hypercapnia; Ventilator Associated Pneumonia; Complication of Anesthesia; Postoperative Complications

Outcome Measures

Primary Outcomes (8)

• SpO2/FiO2 ratio

  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

  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

  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

  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

  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

  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

  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

  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

Study Arms (1)

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

Intermittent Positive pressure ventilation PROCEDURE

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

GA group

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

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

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

UMCG

Groningen, 9700RB, Netherlands

Location

MeSH Terms

Conditions

Hypoxia; Hypercapnia; Pneumonia, Ventilator-Associated; Postoperative Complications

Interventions

Intermittent Positive-Pressure Ventilation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Clemens Barends, phd

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clemens Barends, phd

CONTACT

+31-503616161; c.r.m.barends@umcg.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: March 7, 2024
• Study Start: March 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: March 7, 2024

Record last verified: 2024-02

Locations

NL (1)