Clinical trial NCT06638658: Postoperative Complications of Orthopedic Surgery in Patients From High-altitude Regions
Official title: Postoperative Complications of Orthopedic Surgery in Patients From High-altitude Regions: a Cohort Study.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Orthopedic Surgery
Postoperative Complications
High Altitude
Keywords: High-altitude population
Perioperative cohort
Orthopedic surgery
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who have lived in high-altitude regions scheduled for 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative venous thromboembolism
timeFrame: During hospitalization
Secondary outcomes:
measure: Postoperative venous thromboembolism
timeFrame: Up to 2 weeks postoperatively
measure: A composite of postoperative pulmonary complications
timeFrame: During hospitalization
measure: Postoperative major adverse cardiovascular events
timeFrame: During hospitalization
measure: Postoperative nausea and vomiting
timeFrame: During hospitalization
measure: The quality of postoperative recovery
timeFrame: During hospitalization
measure: Chronic pain after surgery
timeFrame: Up to 1 year postoperatively
measure: Postoperative quality of life assessment
timeFrame: Up to 1 year postoperatively
Other outcomes:
measure: Pain scores of movement-evoked pain
timeFrame: During hospitalization
measure: Pain scores at rest
timeFrame: During hospitalization
measure: Surgical site infection
timeFrame: During hospitalization
measure: Time of Bowel function recovery
timeFrame: During hospitalization
measure: Sleep quality after surgery
timeFrame: Up to 1 year postoperatively
measure: Postoperative anxiety assessment
timeFrame: Up to 1 year postoperatively
measure: Postoperative depression assessment
timeFrame: Up to 1 year postoperatively
measure: Postoperative cognitive function assessment
timeFrame: Up to 1 year postoperatively
Locations:
Study officials:
affiliation: West China Hospital
name: Chunling Jiang, PhD
role: PRINCIPAL_INVESTIGATOR
References: