Postoperative Complications of Orthopedic Surgery in Patients From High-altitude Regions

Not yet recruiting

• Conditions: Orthopedic Surgery; Postoperative Complications; High Altitude

• Registration Number: NCT06638658
• Lead Sponsor: West China Hospital

Brief Summary

This study will focus on orthopedic surgery patients from high-altitude regions, utilizing smart wearables and monitoring tools to gather perioperative data, including heart rate, oxygen saturation, sleep quality, stress levels, and other relevant metrics. Regular follow-ups will assess recovery and complications, in addition to collecting medical records, lab results, imaging data, and other pertinent records. The ultimate goal is to establish a comprehensive follow-up cohort of orthopedic surgery patients from high-altitude areas.

Detailed Description

Prolonged exposure to hypoxic and low-pressure environments leads to structural remodeling and functional abnormalities in the cardiovascular, respiratory, and hematological systems of high-altitude populations. This elevates the risk of postoperative complications, particularly in patients undergoing orthopedic surgery, significantly impacting their recovery and quality of life. This study will focus on orthopedic surgery patients from high-altitude regions. Using smart wearable devices and other monitoring tools, comprehensive perioperative dynamic data of participants, including heart rate, heart rate variability, oxygen saturation, respiratory rate, sleep quality, activity levels, stress index, and other relevant indicators will be collected. Regular follow-ups will be conducted to evaluate postoperative recovery and monitor the incidence of perioperative complications. Additionally, perioperative data such as electronic medical records, laboratory test results, ECG waveforms, echocardiography, chest CT images, and other pertinent records will be also collected. Through that, this study aims to establish a follow-up cohort of orthopedic surgery patients from high-altitude regions.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-05
• Study First Submitted QC: 2024-10-10
• Last Update Submitted: 2024-10-10
• Study First Posted: 2024-10-11
• Last Update Posted: 2024-10-11
• Study Start: 2024-11-15
• Primary Completion: 2028-10-31
• Study Completion: 2029-10-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. Age ≥ 18 years;
2. ASA classification I-III;
3. Patients who have lived at an altitude above 2500 meters for more than 6 months ;
4. Patients scheduled for elective orthopedic surgery.

Exclusion Criteria

1. Urgent or emergent surgery;
2. Expected hospital stay < 48 hours;
3. Inability to provide informed consent；
4. Patients who have been out of high-altitude regions for over three months.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative venous thromboembolism	During hospitalization	Defined according to the European Perioperative Clinical Outcome (EPCO) criteria, including both deep vein thrombosis and pulmonary embolism.

Secondary Outcome Measures

Name	Time	Method
Postoperative venous thromboembolism	Up to 2 weeks postoperatively	Defined according to the European Perioperative Clinical Outcome (EPCO) criteria, including both deep vein thrombosis and pulmonary embolism.
A composite of postoperative pulmonary complications	During hospitalization	Defined according to the European Perioperative Clinical Outcome (EPCO) criteria, including respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, and aspiration pneumonia.
Postoperative major adverse cardiovascular events	During hospitalization	Defined according to the European Perioperative Clinical Outcome (EPCO) criteria, including non-fatal cardiac arrest, acute myocardial infarction, congestive heart failure, new cardiac arrhythmias, angina, et al.
Postoperative nausea and vomiting	During hospitalization	Nausea and vomiting
The quality of postoperative recovery	During hospitalization	Assessed using QoR-15 score at different time points after surgery
Chronic pain after surgery	Up to 1 year postoperatively	Assessed using NRS scale and BPI at different time points after surgery
Postoperative quality of life assessment	Up to 1 year postoperatively	Assessed using WHODAS2.0 scores at different time points after surgery