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Clinical Trials/NCT06798883
NCT06798883Not yet recruitingNot Applicable

Perioperative Respiratory Support and Postoperative Outcomes: Russian National Epidemiological Study "RuVent-A"

Russian Federation of Anesthesiologists and Reanimatologists0 sites1,000 target enrollmentStarted: April 7, 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
1,000
Primary Endpoint
Incidence of Postoperative Pulmonary Complications (PPCs)

Study Overview

Brief Summary

This study aims to evaluate the methodology and parameters of perioperative respiratory support (RS) and the frequency of postoperative pulmonary complications (PPCs) in the Russian Federation. The study will analyze respiratory support strategies, equipment availability, and their correlation with PPC outcomes in surgical patients.

Detailed Description

Globally, around 230 million surgical procedures requiring general anesthesia and mechanical ventilation are performed annually. Postoperative pulmonary complications (PPCs) significantly impact clinical outcomes, increasing morbidity and hospitalization duration. Cohort studies have reported a 20-30% risk of PPCs in patients undergoing general anesthesia. Protective ventilation strategies, including low tidal volumes (6-8 mL/kg predicted body weight) and positive end-expiratory pressure (PEEP), have shown to reduce PPCs. However, high tidal volumes (10-15 mL/kg) remain prevalent in routine practice.

The "RuVent-A" study will collect data on respiratory support methodologies, initial ventilation parameters, types of surgical interventions, and associated PPC rates in the Russian Federation. This observational study will analyze patient and equipment data across participating centers without altering routine clinical practices.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients aged ≥18 years undergoing surgical procedures with general anesthesia and respiratory support.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Incidence of Postoperative Pulmonary Complications (PPCs)

Time Frame: 30 days after surgery

The frequency of postoperative pulmonary complications (PPCs) will be measured, including conditions such as atelectasis, hypoxemia, pneumonia, acute respiratory distress syndrome (ARDS), and bronchospasm. PPCs will be evaluated based on clinical and diagnostic criteria following surgery.

Secondary Outcomes

  • Level of end-expiratory pressure during anesthesia(During surgery (intraoperative period).)
  • Use of Alveolar Recruitment Maneuvers During Anesthesia(During surgery (intraoperative period).)
  • Frequency of Non-Invasive Ventilation and High-Flow Oxygen Therapy Post-Extubation(30 days after surgery)
  • Duration of Intraoperative and Postoperative Mechanical Ventilation(Intraoperative and up to 24 hours postoperatively.)
  • Incidence of Hypoxemia Post-Surgery(30 days after surgery)
  • Level of inspiratory oxygen fraction during anesthesia(During surgery (intraoperative period).)
  • Level of tidal volume during anesthesia(During surgery (intraoperative period).)

Investigators

Sponsor
Russian Federation of Anesthesiologists and Reanimatologists
Sponsor Class
Other
Responsible Party
Sponsor

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