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

Postoperative Complications of Orthopedic Surgery in Patients From High-altitude Regions: a Cohort Study.

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06638658
Enrollment
400
Registered
2024-10-15
Start date
2024-11-15
Completion date
2029-10-31
Last updated
2024-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High Altitude, Orthopedic Surgery, Postoperative Complications

Keywords

High-altitude population, Perioperative cohort, Orthopedic surgery

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.

Interventions

None listed

Sponsors

West China Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Postoperative venous thromboembolismDuring hospitalizationDefined according to the European Perioperative Clinical Outcome (EPCO) criteria, including both deep vein thrombosis and pulmonary embolism.

Secondary

MeasureTime frameDescription
Postoperative major adverse cardiovascular eventsDuring hospitalizationDefined 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 vomitingDuring hospitalizationNausea and vomiting
The quality of postoperative recoveryDuring hospitalizationAssessed using QoR-15 score at different time points after surgery
Chronic pain after surgeryUp to 1 year postoperativelyAssessed using NRS scale and BPI at different time points after surgery
Postoperative quality of life assessmentUp to 1 year postoperativelyAssessed using WHODAS2.0 scores at different time points after surgery
A composite of postoperative pulmonary complicationsDuring hospitalizationDefined according to the European Perioperative Clinical Outcome (EPCO) criteria, including respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, bronchospasm, and aspiration pneumonia.
Postoperative venous thromboembolismUp to 2 weeks postoperativelyDefined according to the European Perioperative Clinical Outcome (EPCO) criteria, including both deep vein thrombosis and pulmonary embolism.

Other

MeasureTime frameDescription
Postoperative cognitive function assessmentUp to 1 year postoperativelyAssessed using AD-8 and three-word recall test scores at different time points after surgery
Pain scores of movement-evoked painDuring hospitalizationAssessed using NRS scale and BPI at different time points after surgery
Pain scores at restDuring hospitalizationUsing NRS scale and BPI at different time points after surgery
Surgical site infectionDuring hospitalizationDefined according to the European Perioperative Clinical Outcome (EPCO) criteria
Time of Bowel function recoveryDuring hospitalizationDefined as time to first defecation or flatus
Sleep quality after surgeryUp to 1 year postoperativelyAssessed using the Pittsburgh Sleep Quality Index (PSQI) and the Morningness-Eveningness Questionnaire (MEQ) at different time points after surgery
Postoperative anxiety assessmentUp to 1 year postoperativelyAssessed using GAD-7 scores at different time points after surgery
Postoperative depression assessmentUp to 1 year postoperativelyAssessed using PHQ-9 scores at different time points after surgery

Contacts

Primary ContactChunling Jiang, PhD
jiangchunling@scu.edu.cn+86 02885422114
Backup ContactFengming Luo, phD
jiangchunling@scu.edu.cn+86 85423593

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026