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NCT Number: NCT06798883

Perioperative Respiratory Support and Postoperative Outcomes

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.

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Key information

Conditions

Postoperative Respiratory Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • No

Treatment and study plan

Primary outcomes

  1. 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

  1. Level of end-expiratory pressure during anesthesia

    Time frame: During surgery (intraoperative period).

    The level of end-expiratory pressure during anesthesia used by the anesthesiologist will be assessed

  2. Use of Alveolar Recruitment Maneuvers During Anesthesia

    Time frame: During surgery (intraoperative period).

    The frequency of alveolar recruitment maneuvers used during general anesthesia will be assessed.

  3. Frequency of Non-Invasive Ventilation and High-Flow Oxygen Therapy Post-Extubation

    Time frame: 30 days after surgery

    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.

  4. Duration of Intraoperative and Postoperative Mechanical Ventilation

    Time frame: Intraoperative and up to 24 hours postoperatively.

    Duration of Intraoperative and Postoperative Mechanical Ventilation

  5. Incidence of Hypoxemia Post-Surgery

    Time frame: 30 days after surgery

    The occurrence of hypoxemia (SpO2 <92%) after surgery will be documented, along with the requirement for oxygen therapy.

  6. Level of inspiratory oxygen fraction during anesthesia

    Time frame: During surgery (intraoperative period).

    The level of inspiratory oxygen fraction during anesthesia used by the anesthesiologist will be assessed

  7. Level of tidal volume during anesthesia

    Time frame: During surgery (intraoperative period).

    The level of tidal during anesthesia used by the anesthesiologist will be assessed

Study contacts

Contact information is provided by the study sponsor or research team.

Andrey Yaroshetskiy, MD

CONTACT

[email protected]

+79859900148

Nikita Trembach, MD

CONTACT

[email protected]

+79528589299

Sponsors and collaborators

Lead sponsor

Russian Federation of Anesthesiologists and Reanimatologists

Other

Registry information

Official study title

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

Acronym: RuVent-A

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 29, 2025
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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