Clinical trial NCT06798883: Perioperative Respiratory Support and Postoperative Outcomes
Official title: Perioperative Respiratory Support and Postoperative Outcomes: Russian National Epidemiological Study "RuVent-A"
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Postoperative Respiratory Complications
Keywords: anesthesia
respiratory support
complications
mechanical ventilation
Lead sponsor: Russian Federation of Anesthesiologists and Reanimatologists
Sponsor class: OTHER
First posted: 2025-01-29
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will include adult patients (aged ≥18 years) undergoing surgical procedures under general anesthesia with respiratory support in participating medical centers across the Russian Federation. The study will focus on a wide range of surgical specialties, including but not limited to general surgery, orthopedics, neurosurgery, vascular surgery, and thoracic surgery.

Patients with various comorbidities (e.g., obesity, chronic obstructive pulmonary disease, smoking, sleep apnea) that may influence respiratory support strategies will be included to provide a comprehensive assessment of perioperative respiratory management and its outcomes.

No specific exclusion criteria will be applied, allowing for the inclusion of a diverse and representative cohort of surgical patients.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* No

Primary outcomes:
measure: Incidence of Postoperative Pulmonary Complications (PPCs)
timeFrame: 30 days after surgery
Secondary outcomes:
measure: Level of end-expiratory pressure during anesthesia
timeFrame: During surgery (intraoperative period).
measure: Use of Alveolar Recruitment Maneuvers During Anesthesia
timeFrame: During surgery (intraoperative period).
measure: Frequency of Non-Invasive Ventilation and High-Flow Oxygen Therapy Post-Extubation
timeFrame: 30 days after surgery
measure: Duration of Intraoperative and Postoperative Mechanical Ventilation
timeFrame: Intraoperative and up to 24 hours postoperatively.
measure: Incidence of Hypoxemia Post-Surgery
timeFrame: 30 days after surgery
measure: Level of inspiratory oxygen fraction during anesthesia
timeFrame: During surgery (intraoperative period).
measure: Level of tidal volume during anesthesia
timeFrame: During surgery (intraoperative period).
Other outcomes:
Locations:
Study officials:
affiliation: Sechenov First Moscow State Medical University
name: Andrey Yaroshetskiy, MD
role: PRINCIPAL_INVESTIGATOR
References: