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

NCT06638658 | Not Yet Recruiting DMC

• 1 other identifier: 20241284
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Orthopedic Surgery; Postoperative Complications; High Altitude

Keywords

High-altitude population; Perioperative cohort; Orthopedic surgery

Outcome Measures

Primary Outcomes (1)

• Postoperative venous thromboembolism

  Defined according to the European Perioperative Clinical Outcome (EPCO) criteria, including both deep vein thrombosis and pulmonary embolism.

  During hospitalization

Secondary Outcomes (7)

• Postoperative venous thromboembolism

  Up to 2 weeks postoperatively

• A composite of postoperative pulmonary complications

  During hospitalization

• Postoperative major adverse cardiovascular events

  During hospitalization

• Postoperative nausea and vomiting

  During hospitalization

• The quality of postoperative recovery

  During hospitalization

Other Outcomes (8)

• Pain scores of movement-evoked pain

  During hospitalization

• Pain scores at rest

  During hospitalization

• Surgical site infection

  During hospitalization

Study Arms (1)

Orthopedic surgery patients from high-altitude regions

high altitude patients Undergoing orthopedic 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

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• West China Hospital: lead

Biospecimen

Retention: SAMPLES WITH DNA

Blood and hair.

MeSH Terms

Conditions

Postoperative Complications; Altitude Sickness

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Chunling Jiang, PhD

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chunling Jiang, PhD

CONTACT

+86 02885422114; jiangchunling@scu.edu.cn

Fengming Luo, phD

CONTACT

+86 85423593; jiangchunling@scu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 5, 2024
• First Posted: October 15, 2024
• Study Start: November 15, 2024
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): October 31, 2029
• Last Updated: October 15, 2024

Record last verified: 2024-10