Perioperative Respiratory Support and Postoperative Outcomes (RuVent-A)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Respiratory Complications

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 Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Nikita Trembach, MD; Phone Number: +79528589299; Email: trembachnv@mail.ru
• Study Contact Backup: Name: Andrey Yaroshetskiy, MD; Phone Number: +79859900148; Email: yaroshetskiyandrei@me.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• No

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Postoperative Pulmonary Complications (PPCs)	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.	30 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of end-expiratory pressure during anesthesia	The level of end-expiratory pressure during anesthesia used by the anesthesiologist will be assessed	During surgery (intraoperative period).
Use of Alveolar Recruitment Maneuvers During Anesthesia	The frequency of alveolar recruitment maneuvers used during general anesthesia will be assessed.	During surgery (intraoperative period).
Frequency of Non-Invasive Ventilation and High-Flow Oxygen Therapy Post-Extubation	The frequency of non-invasive ventilation (NIV) and high-flow oxygen therapy (HFOT) applied after extubation will be evaluated to determine their role in preventing PPCs.	30 days after surgery
Duration of Intraoperative and Postoperative Mechanical Ventilation	Duration of Intraoperative and Postoperative Mechanical Ventilation	Intraoperative and up to 24 hours postoperatively.
Incidence of Hypoxemia Post-Surgery	The occurrence of hypoxemia (SpO2 <92%) after surgery will be documented, along with the requirement for oxygen therapy.	30 days after surgery
Level of inspiratory oxygen fraction during anesthesia	The level of inspiratory oxygen fraction during anesthesia used by the anesthesiologist will be assessed	During surgery (intraoperative period).
Level of tidal volume during anesthesia	The level of tidal during anesthesia used by the anesthesiologist will be assessed	During surgery (intraoperative period).

Collaborators and Investigators

• Sponsor: Russian Federation of Anesthesiologists and Reanimatologists
• Investigators: Principal Investigator: Andrey Yaroshetskiy, MD, Sechenov First Moscow State Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): April 7, 2025
• Primary Completion (Estimated): April 11, 2025
• Study Completion (Estimated): May 11, 2025

Study Registration Dates

• First Submitted: January 22, 2025
• First Submitted That Met QC Criteria: January 27, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 27, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: anesthesia; mechanical ventilation; complications; respiratory support
• Other Study ID Numbers: FARCT0006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Individual Participant Data (IPD) Sharing Statement

Individual participant data (IPD) will not be shared due to the following reasons:

Privacy and Confidentiality: The study involves sensitive patient data, and ensuring patient confidentiality is a top priority. Although the data will be anonymized, sharing IPD could still pose risks of re-identification.

Regulatory and Ethical Considerations: Sharing IPD may not comply with local regulations and ethical guidelines governing patient data use in the Russian Federation.

Study Scope: The primary objective of this study is to analyze aggregated data to inform clinical practices rather than to enable secondary analyses or external collaborations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No