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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Complications; Orthopedic Surgery; High Altitude

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 Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Chunling Jiang, PhD; Phone Number: +86 02885422114; Email: jiangchunling@scu.edu.cn
• Study Contact Backup: Name: Fengming Luo, phD; Phone Number: +86 85423593; Email: jiangchunling@scu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients who have lived in high-altitude regions scheduled for orthopedic surgery.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Orthopedic surgery patients from high-altitude regions; high altitude patients Undergoing orthopedic surgery

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scores of movement-evoked pain	Assessed using NRS scale and BPI at different time points after surgery	During hospitalization
Pain scores at rest	Using NRS scale and BPI at different time points after surgery	During hospitalization
Surgical site infection	Defined according to the European Perioperative Clinical Outcome (EPCO) criteria	During hospitalization
Time of Bowel function recovery	Defined as time to first defecation or flatus	During hospitalization
Sleep quality after surgery	Assessed using the Pittsburgh Sleep Quality Index (PSQI) and the Morningness-Eveningness Questionnaire (MEQ) at different time points after surgery	Up to 1 year postoperatively
Postoperative anxiety assessment	Assessed using GAD-7 scores at different time points after surgery	Up to 1 year postoperatively
Postoperative depression assessment	Assessed using PHQ-9 scores at different time points after surgery	Up to 1 year postoperatively
Postoperative cognitive function assessment	Assessed using AD-8 and three-word recall test scores at different time points after surgery	Up to 1 year postoperatively

Collaborators and Investigators

• Sponsor: West China Hospital
• Investigators: Principal Investigator: Chunling Jiang, PhD, West China Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): November 15, 2024
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): October 31, 2029

Study Registration Dates

• First Submitted: October 5, 2024
• First Submitted That Met QC Criteria: October 10, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): October 15, 2024
• Last Update Submitted That Met QC Criteria: October 10, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Orthopedic surgery; High-altitude population; Perioperative cohort
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Altitude Sickness; Postoperative Complications
• Other Study ID Numbers: 20241284

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No