Perioperative Respiratory Support and Postoperative Outcomes

NCT06798883 | Not Yet Recruiting

• 1 other identifier: FARCT0006
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postoperative Respiratory Complications

Keywords

anesthesia; respiratory support; complications; mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

Sponsors & Collaborators

• Russian Federation of Anesthesiologists and Reanimatologists: lead

Study Officials

• Andrey Yaroshetskiy, MD

  Sechenov First Moscow State Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrey Yaroshetskiy, MD

CONTACT

+79859900148; yaroshetskiyandrei@me.com

Nikita Trembach, MD

CONTACT

+79528589299; trembachnv@mail.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: January 29, 2025
• Study Start: April 7, 2025
• Primary Completion: April 11, 2025
• Study Completion: May 11, 2025
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share