Postoperative Respiratory ComplicationsRuVent-ANCT06798883
Perioperative Respiratory Support and Postoperative Outcomes
An observational study of Postoperative Respiratory Complications, run by Russian Federation of Anesthesiologists and Reanimatologists.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Respiratory Complications
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 7 Apr 2025to 11 May 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients aged ≥18 years undergoing surgical procedures with general anesthesia and respiratory support.
Who cannot join
- No
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Postoperative Respiratory Complications
- Keywords
- anesthesia, respiratory support, complications, mechanical ventilation
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days after surgery
Secondary outcomes (7)
Level of end-expiratory pressure during anesthesia
The level of end-expiratory pressure during anesthesia used by the anesthesiologist will be assessed
Measured: During surgery (intraoperative period).
Use of Alveolar Recruitment Maneuvers During Anesthesia
The frequency of alveolar recruitment maneuvers used during general anesthesia will be assessed.
Measured: 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.
Measured: 30 days after surgery
Duration of Intraoperative and Postoperative Mechanical Ventilation
Duration of Intraoperative and Postoperative Mechanical Ventilation
Measured: 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.
Measured: 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
Measured: During surgery (intraoperative period).
Level of tidal volume during anesthesia
The level of tidal during anesthesia used by the anesthesiologist will be assessed
Measured: During surgery (intraoperative period).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start7 Apr 2025 (estimated)
- Primary completion11 Apr 2025 (estimated)
- Study completion11 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Respiratory ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Russian Federation of Anesthesiologists and Reanimatologists
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrey Yaroshetskiy, MD, Principal investigator, Sechenov First Moscow State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06798883
- Sponsor's protocol ID
- FARCT0006
- Acronym
- RuVent-A
- Status last verified
- Jan 2025
- First submitted
- 22 Jan 2025
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Respiratory Support and Postoperative Outcomes: Russian National Epidemiological Study "RuVent-A"
- ClinicalTrials.gov ID
- NCT06798883
- Acronym / sponsor ID
- RuVent-A / FARCT0006
- Conditions
- Postoperative Respiratory Complications
- Keywords
- anesthesia, respiratory support, complications, mechanical ventilation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Russian Federation of Anesthesiologists and ReanimatologistsUniversity, hospital or other
- Study start
- 7 Apr 2025 (estimated)
- Primary completion
- 11 Apr 2025 (estimated)
- Study completion
- 11 May 2025 (estimated)
- First posted
- 29 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients aged ≥18 years undergoing surgical procedures with general anesthesia and respiratory support.
Key exclusion criteria (1 listed)
- No
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
7 secondary outcomes
Level of end-expiratory pressure during anesthesia
Time frame: During surgery (intraoperative period).
Use of Alveolar Recruitment Maneuvers During Anesthesia
Time frame: During surgery (intraoperative period).
Frequency of Non-Invasive Ventilation and High-Flow Oxygen Therapy Post-Extubation
Time frame: 30 days after surgery
Duration of Intraoperative and Postoperative Mechanical Ventilation
Time frame: Intraoperative and up to 24 hours postoperatively.
Incidence of Hypoxemia Post-Surgery
Time frame: 30 days after surgery
Level of inspiratory oxygen fraction during anesthesia
Time frame: During surgery (intraoperative period).
Level of tidal volume during anesthesia
Time frame: During surgery (intraoperative period).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrey Yaroshetskiy, MD principal investigator
Sechenov First Moscow State Medical University
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Respiratory Complications, run by Russian Federation of Anesthesiologists and Reanimatologists.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrey Yaroshetskiy, MD (+79859900148, yaroshetskiyandrei@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Pulmonary Complications (PPCs) (time frame: 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025; AzTrials last refreshed its copy on 26 Oct 2026.